<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03286218</url>
  </required_header>
  <id_info>
    <org_study_id>16853</org_study_id>
    <secondary_id>H8H-MC-LAHB</secondary_id>
    <nct_id>NCT03286218</nct_id>
  </id_info>
  <brief_title>A Study of the Abuse Potential of Lasmiditan in Participants Who Are Recreational Drug Users</brief_title>
  <official_title>A Randomized, Subject- and Investigator-Blind, Placebo and Active-Controlled Study to Assess the Abuse Potential of Lasmiditan</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eli Lilly and Company</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the abuse potential of study drug lasmiditan.&#xD;
&#xD;
      Lasmiditan will be compared to a marketed benzodiazepine, alprazolam (positive control), as&#xD;
      well as to placebo (dummy substance that looks like lasmiditan or alprazolam without any&#xD;
      active drug) to determine the potential for drug abuse. The dosages will be in tablet form&#xD;
      and will be taken orally (by mouth).&#xD;
&#xD;
      This study will last about 55 days, including screening. Screening will occur within 28 days&#xD;
      prior to qualification phase.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 15, 2017</start_date>
  <completion_date type="Actual">November 20, 2017</completion_date>
  <primary_completion_date type="Actual">November 20, 2017</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacodynamics (PD): Maximal Effect Score (Emax) of Bipolar Drug Liking Visual Analog Scale (VAS) Scores</measure>
    <time_frame>Each Phase: 24 Hours</time_frame>
    <description>The Emax of Bipolar Drug Liking VAS Scores were derived as the maximum at-the-moment Drug Liking VAS score where the time to Emax was the corresponding time point at which the maximum score occurred. The bipolar Drug Liking VAS is consistent with FDA Guidance (January 2017) such that placebo should produce a score between 40 and 60 representing neutral drug-liking (ie, neither like nor dislike); a score ranging from 0 to 100 and a score of 0 indicates strong disliking, and a score of 100 indicates strong liking. Least squares mean (LS mean) was calculated using a linear mixed-effects model, including period, sequence, and treatment as fixed effects, and subject as a random effect, was used to evaluate the hypothesis tests of primary interest (at-the-moment Drug Liking) at the Emax.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan</measure>
    <time_frame>Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours Post Dose</time_frame>
    <description>Pharmacokinetics (PK) defined as the maximum observed drug concentration (Cmax) of lasmiditan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK: Area Under the Curve of Lasmiditan From Zero to Infinity (AUC[0-∞])</measure>
    <time_frame>Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours Post Dose</time_frame>
    <description>PK defined as the area under the curve of lasmiditan from zero to infinity (AUC[0-∞])</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PD: Maximal Drug Effects (Emax) Visual Analog Scale (VAS)</measure>
    <time_frame>Each Phase: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5,3, 3.5, 4, 4.5, 5, 6, 8, 12, 24 Hours Post Dose</time_frame>
    <description>Drug Effects VAS Battery lists a series of measures that evaluate different effects of the abuse potential of the study drug. Scales include: Overall drug liking (overall, my liking for this drug is) and ranges from 0 definitely not to 100 definitely so. Take Drug Again (I would take this drug again) and ranges from 0 definitely not to 100 definitely so. Good effects (I can feel good drug effects) and ranges from 0 definitely not to 100 definitely so. Bad effects (I can feel bad drug effects) and ranges from 0 definitely not to 100 definitely so. High (I am feeling) and ranges from 0 not at all high to 100 extremely high. Emax is derived as the maximum score across all postdose time points for each participant. Least Square (LS) Mean is calculated using the linear mixed-effects model with period, sequence and treatment as fixed effects and participant as a random effect.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PD: Maximal Drug Effects (Emax) VAS (Hallucinations)</measure>
    <time_frame>Each Phase: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5,3, 3.5, 4, 4.5, 5, 6, 8, 12, 24 Hours Post Dose</time_frame>
    <description>Drug Effects VAS Battery lists a series of measures that evaluate different effects of the abuse potential of the study drug. The hallucinations scale is presented meaning (I am hallucinating) and ranges from 0 not at all to 100 extremely. Emax is derived as the maximum score across all postdose time points for each participant. Median and interquartile range are reported for each treatment group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PD: Minimum Drug Effects (Emin) Visual Analog Scale (VAS)</measure>
    <time_frame>Each Phase:Predose, 0.25, 0.5, 1, 1.5, 2, 2.5,3, 3.5, 4, 4.5, 5, 6, 8, 12, 24 Hours Post Dose</time_frame>
    <description>Drug Effects VAS Battery lists a series of measures that evaluate different effects of the abuse potential of the study drug. The scales included: Alertness/Drowsiness (I am feeling) ranges from 0 very drowsy to 100 very alert. Agitation/Relaxation (my mood is) and ranges from 0 very relaxed to 100 very agitated. Emin is derived across all postdose time points for each participant. LS Mean was calculated using the linear mixed-effects model with period, sequence and treatment as fixed effects and participant as a random effect.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PD: Mean Scores on Drug Similarity VAS Measures</measure>
    <time_frame>Each Phase: 24 Hours Post Dose</time_frame>
    <description>Participants marked a point on a 100-mm horizontal line that best represented their response to the given question. The endpoints of each electronic scale were marked with descriptive anchors on a scale from 0 to 100 (Fraser et al. 1961; Bond and Lader 1974; Bigelow 1991; Shram et al. 2010). In the &quot;How similar&quot; questions, ranges from 0 to 100 and a score of 0 indicates definitely not similar, and a score of 100 indicates definitely similar.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">96</enrollment>
  <condition>Recreational Drug Use</condition>
  <condition>Prescription Drug Abuse (Not Dependent)</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo was administered orally in one of five treatment periods</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Alprazolam 2 milligram (mg)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>2 mg of alprazolam was administered orally in one of five treatment periods</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lasmiditan 100 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>100 mg of lasmiditan was administered orally in one of five treatment periods</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lasmiditan 200 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>200 mg of lasmiditan was administered orally in one of five treatment periods</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lasmiditan 400 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>400 mg of lasmiditan was administered orally in one of five treatment periods</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lasmiditan</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>Lasmiditan 100 mg</arm_group_label>
    <arm_group_label>Lasmiditan 200 mg</arm_group_label>
    <arm_group_label>Lasmiditan 400 mg</arm_group_label>
    <other_name>LY573144</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Alprazolam</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>Alprazolam 2 milligram (mg)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Are overtly healthy males or females, as determined by medical history and physical&#xD;
             examination.&#xD;
&#xD;
          -  Have a body mass index (BMI) of 18 to 32 kilograms per meter squared (kg/m²)&#xD;
             inclusive, at the time of screening.&#xD;
&#xD;
          -  Must be recreational drug user and agree not to consume any recreational drugs during&#xD;
             the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have known allergies to lasmiditan, alprazolam, related compounds, or any components&#xD;
             of the formulation, or a history of significant atopy.&#xD;
&#xD;
          -  Are currently seeking or participating in treatment for addiction or substance-related&#xD;
             disorders, or have recovered from substance abuse disorder.&#xD;
&#xD;
          -  Are currently taking excluded prescription or over-the-counter (OTC) medications.&#xD;
&#xD;
          -  Have a history of significant sleep disorder, including sleep apnea or narcolepsy.&#xD;
&#xD;
          -  Have a history of orthostatic hypotension, vertigo, syncope, or presyncope.&#xD;
&#xD;
          -  Have a history of brain injury, including a history of concussions.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)</last_name>
    <role>Study Director</role>
    <affiliation>Eli Lilly and Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vince &amp; Associates Clinical Research, Inc.</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <results_first_submitted>November 8, 2019</results_first_submitted>
  <results_first_submitted_qc>December 20, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">January 10, 2020</results_first_posted>
  <last_update_submitted>December 20, 2019</last_update_submitted>
  <last_update_submitted_qc>December 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alprazolam</mesh_term>
    <mesh_term>Lasmiditan</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 5, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/18/NCT03286218/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 11, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/18/NCT03286218/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Qualification Phase: Participants randomized in a 2-period crossover design with a washout period of at least 72 hours Treatment Phase: Participants randomized to 1 of 10 dosing sequences, irrespective of their qualification randomization, in a 5-period crossover design with a washout period of 3 days in between doses.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Qualification Phase - Alprazolam Then Placebo Sequence 1</title>
          <description>Sequence 1 - One tablet of 1 milligram (mg) alprazolam was administered orally in period 1 then placebo period 2.</description>
        </group>
        <group group_id="P2">
          <title>Qualification Phase - Placebo Then Alprazolam (Alp) Sequence 2</title>
          <description>Sequence 2 - Placebo was administered orally period 1 then one tablet of 2 mg alprazolam period 2.</description>
        </group>
        <group group_id="P3">
          <title>Sequence 1</title>
          <description>Sequence 1, Periods 1 - 5: (Placebo, 100 mg Las, 2 mg Alp, 200 mg Las, then 400 mg Las)&#xD;
All participants received:&#xD;
Period 1: Placebo Period 2: 100 mg Las Period 3: 200 mg Las Period 4: 400 mg Las Period 5: 2 mg Alp&#xD;
Orally with a 3 day washout between doses.</description>
        </group>
        <group group_id="P4">
          <title>Sequence 2</title>
          <description>Sequence 2 , Periods 1 - 5: (100 mg Las, 200 mg Las, Placebo, 400 mg Las, then 2 mg Alp)&#xD;
All participants received:&#xD;
Period 1: 100 mg Las Period 2: 200 mg Las Period 3: Placebo Period 4: 400 mg Las Period 5: 2 mg Alp&#xD;
Orally with a 3 day washout between doses.</description>
        </group>
        <group group_id="P5">
          <title>Sequence 3</title>
          <description>Sequence 3, Periods 1 - 5: (200 mg Las, 400 mg Las, 100 mg Las, 2 mg Alp, then Placebo)&#xD;
All participants received:&#xD;
Period 1: 200 mg Las Period 2: 400 mg Las Period 3: 100 mg Las Period 4: 2 mg Las Period 5: Placebo&#xD;
Orally with a 3 day washout between doses.</description>
        </group>
        <group group_id="P6">
          <title>Sequence 4</title>
          <description>Sequence 4, Periods 1 - 5: (400 mg Las, 2 mg Alp, 200 mg Las, Placebo, then 100 mg Las)&#xD;
All participants received:&#xD;
Period 1: 400 mg Las Period 2: 2 mg Alp Period 3: 200 mg Las Period 4: Placebo Period 5: 100 mg Las&#xD;
Orally with a 3 day washout between doses.</description>
        </group>
        <group group_id="P7">
          <title>Sequence 5</title>
          <description>Sequence 5, Periods 1 - 5: (2 mg Alp, Placebo, 400 mg Las, then 200 mg Las)&#xD;
All participants received:&#xD;
Period 1: 2 mg Alp Period 2: Placebo Period 3: 400 mg Las Period 4: 200 mg Las Period 5: 100 mg Las&#xD;
Orally with a 3 day washout between doses.</description>
        </group>
        <group group_id="P8">
          <title>Sequence 6</title>
          <description>Sequence 6, Periods 1 - 5 (400 mg Las, 200 mg Las, 2 mg Alp, 100 mg Las, then Placebo)&#xD;
All participants received:&#xD;
Period 1: 400 mg Las Period 2: 200 mg Las Period 3: 2 mg Alp Period 4: 100 mg Las Period 5: Placebo&#xD;
Orally with a 3 day washout between doses.</description>
        </group>
        <group group_id="P9">
          <title>Sequence 7</title>
          <description>Sequence 7, Periods 1-5: (2 mg Alp, 400 mg Las, Placebo, 200 mg Las, then 100 mg Las)&#xD;
All participants received:&#xD;
Period 1: 2 mg Alp Period 2: 400 mg Las Period 3: Placebo Period 4: 200 mg Las Period 5: 100 mg Las&#xD;
Orally with a 3 day washout between doses.</description>
        </group>
        <group group_id="P10">
          <title>Sequence 8</title>
          <description>Sequence 8, Periods 1 - 5: Placebo, 2 mg Lap, 100 mg Las, 400 mg Las, then 200 mg Las)&#xD;
All participants received:&#xD;
Period 1: Placebo Period 2: 2 mg Las Period 3: 100 mg Las Period 4: 400 mg Las Period 5: 200 mg Las&#xD;
Orally with a 3 day washout between doses.</description>
        </group>
        <group group_id="P11">
          <title>Sequence 9</title>
          <description>Sequence 9, Periods 1 - 5: (100 mg Las, Placebo, 200 mg Las, 2 mg Alp, 400 mg Las)&#xD;
All participants received:&#xD;
Period 1: 100 mg Las Period 2: Placebo Period 3: 200 mg Las Period 4: 2 mg Alp Period 5: 400 mg Las&#xD;
Orally with a 3 day washout between doses.</description>
        </group>
        <group group_id="P12">
          <title>Sequence 10</title>
          <description>Sequence 10, Periods 1 - 5: (200 mg Las, 100 mg Las, 400 mg Las, Placebo, then 2 mg Alp)&#xD;
All participants received:&#xD;
Period 1: 200 mg Las Period 2: 100 mg Las Period 3: 400 mg Las Period 4: Placebo Period 5: 2 mg Alp&#xD;
Orally with a 3 day washout between doses.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Qualification Phase Period 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="48"/>
                <participants group_id="P2" count="48"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least One Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="47"/>
                <participants group_id="P2" count="47"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="47"/>
                <participants group_id="P2" count="47"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Qualification Phase Period 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="47"/>
                <participants group_id="P2" count="47"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="28"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="19"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Failure to meet randomization criteria</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Treatment Phase Period 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0">Participants completed the Qualification Phase prior to entering the Treatment Phase.</participants>
                <participants group_id="P2" count="0">Participants completed the Qualification Phase prior to entering the Treatment Phase.</participants>
                <participants group_id="P3" count="6">Participants completed the Qualification Phase and crossed over to the Treatment Phase.</participants>
                <participants group_id="P4" count="6">Participants completed the Qualification Phase and crossed over to the Treatment Phase.</participants>
                <participants group_id="P5" count="5">Participants completed the Qualification Phase and crossed over to the Treatment Phase.</participants>
                <participants group_id="P6" count="6">Participants completed the Qualification Phase and crossed over to the Treatment Phase.</participants>
                <participants group_id="P7" count="6">Participants completed the Qualification Phase and crossed over to the Treatment Phase.</participants>
                <participants group_id="P8" count="6">Participants completed the Qualification Phase and crossed over to the Treatment Phase.</participants>
                <participants group_id="P9" count="6">Participants completed the Qualification Phase and crossed over to the Treatment Phase.</participants>
                <participants group_id="P10" count="6">Participants completed the Qualification Phase and crossed over to the Treatment Phase.</participants>
                <participants group_id="P11" count="5">Participants completed the Qualification Phase and crossed over to the Treatment Phase.</participants>
                <participants group_id="P12" count="6">Participants completed the Qualification Phase and crossed over to the Treatment Phase.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least One Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="6"/>
                <participants group_id="P7" count="6"/>
                <participants group_id="P8" count="6"/>
                <participants group_id="P9" count="6"/>
                <participants group_id="P10" count="6"/>
                <participants group_id="P11" count="5"/>
                <participants group_id="P12" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="5"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="5"/>
                <participants group_id="P7" count="6"/>
                <participants group_id="P8" count="6"/>
                <participants group_id="P9" count="6"/>
                <participants group_id="P10" count="6"/>
                <participants group_id="P11" count="5"/>
                <participants group_id="P12" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Treatment Phase Period 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="5"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="5"/>
                <participants group_id="P7" count="6"/>
                <participants group_id="P8" count="6"/>
                <participants group_id="P9" count="6"/>
                <participants group_id="P10" count="6"/>
                <participants group_id="P11" count="5"/>
                <participants group_id="P12" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="5"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="5"/>
                <participants group_id="P7" count="6"/>
                <participants group_id="P8" count="6"/>
                <participants group_id="P9" count="6"/>
                <participants group_id="P10" count="6"/>
                <participants group_id="P11" count="5"/>
                <participants group_id="P12" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Treatment Phase Period 3</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="5"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="5"/>
                <participants group_id="P7" count="6"/>
                <participants group_id="P8" count="6"/>
                <participants group_id="P9" count="6"/>
                <participants group_id="P10" count="6"/>
                <participants group_id="P11" count="5"/>
                <participants group_id="P12" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="5"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="5"/>
                <participants group_id="P7" count="6"/>
                <participants group_id="P8" count="6"/>
                <participants group_id="P9" count="6"/>
                <participants group_id="P10" count="6"/>
                <participants group_id="P11" count="5"/>
                <participants group_id="P12" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Treatment Phase Period 4</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="5"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="5"/>
                <participants group_id="P7" count="6"/>
                <participants group_id="P8" count="6"/>
                <participants group_id="P9" count="6"/>
                <participants group_id="P10" count="6"/>
                <participants group_id="P11" count="5"/>
                <participants group_id="P12" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="5"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="5"/>
                <participants group_id="P7" count="6"/>
                <participants group_id="P8" count="6"/>
                <participants group_id="P9" count="6"/>
                <participants group_id="P10" count="6"/>
                <participants group_id="P11" count="5"/>
                <participants group_id="P12" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Treatment Phase Period 5</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="5"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="5"/>
                <participants group_id="P7" count="6"/>
                <participants group_id="P8" count="6"/>
                <participants group_id="P9" count="6"/>
                <participants group_id="P10" count="6"/>
                <participants group_id="P11" count="5"/>
                <participants group_id="P12" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="5"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="5"/>
                <participants group_id="P7" count="6"/>
                <participants group_id="P8" count="6"/>
                <participants group_id="P9" count="6"/>
                <participants group_id="P10" count="6"/>
                <participants group_id="P11" count="5"/>
                <participants group_id="P12" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All randomized participants.</population>
      <group_list>
        <group group_id="B1">
          <title>Overall Participants</title>
          <description>All participants received one dose of alprazolam and placebo in the qualification phase and participants received at least one dose lasmiditan, alprazolam and/or placebo in the treatment phase.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="96"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31.4" spread="8.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="91"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="69"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pharmacodynamics (PD): Maximal Effect Score (Emax) of Bipolar Drug Liking Visual Analog Scale (VAS) Scores</title>
        <description>The Emax of Bipolar Drug Liking VAS Scores were derived as the maximum at-the-moment Drug Liking VAS score where the time to Emax was the corresponding time point at which the maximum score occurred. The bipolar Drug Liking VAS is consistent with FDA Guidance (January 2017) such that placebo should produce a score between 40 and 60 representing neutral drug-liking (ie, neither like nor dislike); a score ranging from 0 to 100 and a score of 0 indicates strong disliking, and a score of 100 indicates strong liking. Least squares mean (LS mean) was calculated using a linear mixed-effects model, including period, sequence, and treatment as fixed effects, and subject as a random effect, was used to evaluate the hypothesis tests of primary interest (at-the-moment Drug Liking) at the Emax.</description>
        <time_frame>Each Phase: 24 Hours</time_frame>
        <population>All randomized participants who received at least one dose of study drug had evaluable PD data in each of the 5 periods.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo was administered orally in one of five treatment periods.</description>
          </group>
          <group group_id="O2">
            <title>Alprazolam - 2 mg</title>
            <description>2 mg of Alprazolam administered orally in one of five treatment periods</description>
          </group>
          <group group_id="O3">
            <title>Lasmiditan - 100 mg</title>
            <description>100 mg of lasmiditan administered orally in one of five treatment periods</description>
          </group>
          <group group_id="O4">
            <title>Lasmiditan - 200 mg</title>
            <description>200 mg of lasmiditan administered orally in one of five treatment periods</description>
          </group>
          <group group_id="O5">
            <title>Lasmiditan - 400 mg</title>
            <description>400 mg of lasmiditan administered orally in one of five treatment periods</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacodynamics (PD): Maximal Effect Score (Emax) of Bipolar Drug Liking Visual Analog Scale (VAS) Scores</title>
          <description>The Emax of Bipolar Drug Liking VAS Scores were derived as the maximum at-the-moment Drug Liking VAS score where the time to Emax was the corresponding time point at which the maximum score occurred. The bipolar Drug Liking VAS is consistent with FDA Guidance (January 2017) such that placebo should produce a score between 40 and 60 representing neutral drug-liking (ie, neither like nor dislike); a score ranging from 0 to 100 and a score of 0 indicates strong disliking, and a score of 100 indicates strong liking. Least squares mean (LS mean) was calculated using a linear mixed-effects model, including period, sequence, and treatment as fixed effects, and subject as a random effect, was used to evaluate the hypothesis tests of primary interest (at-the-moment Drug Liking) at the Emax.</description>
          <population>All randomized participants who received at least one dose of study drug had evaluable PD data in each of the 5 periods.</population>
          <units>millimeter (mm)</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="53"/>
                <count group_id="O3" value="53"/>
                <count group_id="O4" value="53"/>
                <count group_id="O5" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.0" spread="1.94"/>
                    <measurement group_id="O2" value="85.4" spread="1.94"/>
                    <measurement group_id="O3" value="68.6" spread="1.94"/>
                    <measurement group_id="O4" value="73.3" spread="1.94"/>
                    <measurement group_id="O5" value="76.6" spread="1.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 14 mm.</non_inferiority_desc>
            <param_type>Least Squares (LS) Mean Difference</param_type>
            <param_value>32.4</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>28.4</ci_lower_limit>
            <ci_upper_limit>36.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The non-inferiority (NI) margin for Lasmiditan doses vs Placebo is 14 mm.</non_inferiority_desc>
            <param_type>LS Mean Difference</param_type>
            <param_value>15.6</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>11.7</ci_lower_limit>
            <ci_upper_limit>19.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The non-inferiority (NI) margin for Lasmiditan doses vs Placebo is 14 mm.</non_inferiority_desc>
            <param_type>LS Mean Difference</param_type>
            <param_value>20.3</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>16.3</ci_lower_limit>
            <ci_upper_limit>24.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The non-inferiority (NI) margin for Lasmiditan doses vs Placebo is 14 mm.</non_inferiority_desc>
            <param_type>LS Mean Difference</param_type>
            <param_value>23.6</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>19.6</ci_lower_limit>
            <ci_upper_limit>27.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The non-inferiority (NI) margin for Alprazolam and Lasmiditan 100 mg dose is 5 mm.</non_inferiority_desc>
            <param_type>LS Mean Difference</param_type>
            <param_value>16.8</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>12.8</ci_lower_limit>
            <ci_upper_limit>20.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The non-inferiority (NI) margin for Alprazolam and Lasmiditan 200 mg dose is 5 mm.</non_inferiority_desc>
            <param_type>LS Mean Difference</param_type>
            <param_value>12.1</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>8.10</ci_lower_limit>
            <ci_upper_limit>16.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The non-inferiority (NI) margin for Alprazolam and Lasmiditan 400 mg dose is 5 mm.</non_inferiority_desc>
            <param_type>LS Mean Difference</param_type>
            <param_value>8.79</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>4.8</ci_lower_limit>
            <ci_upper_limit>12.8</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan</title>
        <description>Pharmacokinetics (PK) defined as the maximum observed drug concentration (Cmax) of lasmiditan</description>
        <time_frame>Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours Post Dose</time_frame>
        <population>All randomized participants who received at least one dose of study drug and had evaluable PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>Lasmiditan - 100 mg</title>
            <description>100 mg of lasmiditan administered orally in one of five treatment periods</description>
          </group>
          <group group_id="O2">
            <title>Lasmiditan - 200 mg</title>
            <description>200 of lasmiditan administered orally in one of five treatment periods</description>
          </group>
          <group group_id="O3">
            <title>Lasmiditan - 400 mg</title>
            <description>400 mg of lasmiditan administered orally in one of five treatment periods</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan</title>
          <description>Pharmacokinetics (PK) defined as the maximum observed drug concentration (Cmax) of lasmiditan</description>
          <population>All randomized participants who received at least one dose of study drug and had evaluable PK data.</population>
          <units>nanogram/milliliter (ng/mL)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="55"/>
                <count group_id="O3" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="132" spread="37"/>
                    <measurement group_id="O2" value="299" spread="35"/>
                    <measurement group_id="O3" value="689" spread="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PK: Area Under the Curve of Lasmiditan From Zero to Infinity (AUC[0-∞])</title>
        <description>PK defined as the area under the curve of lasmiditan from zero to infinity (AUC[0-∞])</description>
        <time_frame>Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours Post Dose</time_frame>
        <population>All randomized participants who received at least one dose of study drug and had evaluable PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>Lasmiditan - 100 mg</title>
            <description>100 mg lasmiditan administered orally in one of five treatment periods</description>
          </group>
          <group group_id="O2">
            <title>Lasmiditan - 200 mg</title>
            <description>200 mg of lasmiditan administered orally in one of five treatment periods</description>
          </group>
          <group group_id="O3">
            <title>Lasmiditan - 400 mg Dose</title>
            <description>400 of lasmiditan administered orally in one of five treatment periods</description>
          </group>
        </group_list>
        <measure>
          <title>PK: Area Under the Curve of Lasmiditan From Zero to Infinity (AUC[0-∞])</title>
          <description>PK defined as the area under the curve of lasmiditan from zero to infinity (AUC[0-∞])</description>
          <population>All randomized participants who received at least one dose of study drug and had evaluable PK data.</population>
          <units>nanogram*hour/milliliter (ng*h/mL)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="55"/>
                <count group_id="O3" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="856" spread="32"/>
                    <measurement group_id="O2" value="1810" spread="35"/>
                    <measurement group_id="O3" value="3920" spread="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PD: Maximal Drug Effects (Emax) Visual Analog Scale (VAS)</title>
        <description>Drug Effects VAS Battery lists a series of measures that evaluate different effects of the abuse potential of the study drug. Scales include: Overall drug liking (overall, my liking for this drug is) and ranges from 0 definitely not to 100 definitely so. Take Drug Again (I would take this drug again) and ranges from 0 definitely not to 100 definitely so. Good effects (I can feel good drug effects) and ranges from 0 definitely not to 100 definitely so. Bad effects (I can feel bad drug effects) and ranges from 0 definitely not to 100 definitely so. High (I am feeling) and ranges from 0 not at all high to 100 extremely high. Emax is derived as the maximum score across all postdose time points for each participant. Least Square (LS) Mean is calculated using the linear mixed-effects model with period, sequence and treatment as fixed effects and participant as a random effect.</description>
        <time_frame>Each Phase: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5,3, 3.5, 4, 4.5, 5, 6, 8, 12, 24 Hours Post Dose</time_frame>
        <population>All randomized participants who received at least one dose of study drug and had evaluable PD data, and completed the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo was administered orally in one of five treatment periods.</description>
          </group>
          <group group_id="O2">
            <title>Alprazolam - 2 mg</title>
            <description>2 mg of Alprazolam administered orally in one of five treatment periods</description>
          </group>
          <group group_id="O3">
            <title>Lasmiditan - 100 mg</title>
            <description>100 mg of lasmiditan administered orally in one of five treatment periods</description>
          </group>
          <group group_id="O4">
            <title>Lasmiditan - 200 mg</title>
            <description>200 mg of lasmiditan administered orally in one of five treatment periods</description>
          </group>
          <group group_id="O5">
            <title>Lasmiditan - 400 mg</title>
            <description>400 mg of lasmiditan administered orally in one of five treatment periods</description>
          </group>
        </group_list>
        <measure>
          <title>PD: Maximal Drug Effects (Emax) Visual Analog Scale (VAS)</title>
          <description>Drug Effects VAS Battery lists a series of measures that evaluate different effects of the abuse potential of the study drug. Scales include: Overall drug liking (overall, my liking for this drug is) and ranges from 0 definitely not to 100 definitely so. Take Drug Again (I would take this drug again) and ranges from 0 definitely not to 100 definitely so. Good effects (I can feel good drug effects) and ranges from 0 definitely not to 100 definitely so. Bad effects (I can feel bad drug effects) and ranges from 0 definitely not to 100 definitely so. High (I am feeling) and ranges from 0 not at all high to 100 extremely high. Emax is derived as the maximum score across all postdose time points for each participant. Least Square (LS) Mean is calculated using the linear mixed-effects model with period, sequence and treatment as fixed effects and participant as a random effect.</description>
          <population>All randomized participants who received at least one dose of study drug and had evaluable PD data, and completed the study.</population>
          <units>mm</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="53"/>
                <count group_id="O3" value="53"/>
                <count group_id="O4" value="53"/>
                <count group_id="O5" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall Drug Liking</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.1" spread="2.41"/>
                    <measurement group_id="O2" value="86.2" spread="2.41"/>
                    <measurement group_id="O3" value="71.7" spread="2.41"/>
                    <measurement group_id="O4" value="72.2" spread="2.41"/>
                    <measurement group_id="O5" value="77.4" spread="2.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Take Drug Again</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.0" spread="2.70"/>
                    <measurement group_id="O2" value="86.0" spread="2.70"/>
                    <measurement group_id="O3" value="71.1" spread="2.70"/>
                    <measurement group_id="O4" value="72.7" spread="2.70"/>
                    <measurement group_id="O5" value="77.3" spread="2.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Good Effects</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.8" spread="4.10"/>
                    <measurement group_id="O2" value="80.5" spread="4.10"/>
                    <measurement group_id="O3" value="46.4" spread="4.10"/>
                    <measurement group_id="O4" value="62.9" spread="4.10"/>
                    <measurement group_id="O5" value="63.8" spread="4.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bad Effects</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.47" spread="3.22"/>
                    <measurement group_id="O2" value="22.9" spread="3.22"/>
                    <measurement group_id="O3" value="7.51" spread="3.22"/>
                    <measurement group_id="O4" value="9.75" spread="3.22"/>
                    <measurement group_id="O5" value="15.0" spread="3.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Effects</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.35" spread="4.05"/>
                    <measurement group_id="O2" value="83.7" spread="4.05"/>
                    <measurement group_id="O3" value="53.3" spread="4.05"/>
                    <measurement group_id="O4" value="65.1" spread="4.05"/>
                    <measurement group_id="O5" value="73.2" spread="4.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.61" spread="3.89"/>
                    <measurement group_id="O2" value="77.2" spread="3.89"/>
                    <measurement group_id="O3" value="43.0" spread="3.89"/>
                    <measurement group_id="O4" value="56.1" spread="3.89"/>
                    <measurement group_id="O5" value="67.0" spread="3.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Overall Drug Liking</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>33.1</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>28.5</ci_lower_limit>
            <ci_upper_limit>37.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Overall Drug Liking</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>18.6</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>14.0</ci_lower_limit>
            <ci_upper_limit>23.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Overall Drug Liking</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>19.1</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>14.5</ci_lower_limit>
            <ci_upper_limit>23.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>Overall Drug Liking</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>24.3</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>19.7</ci_lower_limit>
            <ci_upper_limit>28.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Take drug again</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>34.0</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>29.1</ci_lower_limit>
            <ci_upper_limit>38.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Take drug again</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>19.1</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>14.2</ci_lower_limit>
            <ci_upper_limit>24.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Take drug again</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>20.6</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>15.7</ci_lower_limit>
            <ci_upper_limit>25.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>Take drug again</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>25.3</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>20.3</ci_lower_limit>
            <ci_upper_limit>30.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Good effects</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>69.7</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>62.1</ci_lower_limit>
            <ci_upper_limit>77.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Good effects</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>35.5</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>27.9</ci_lower_limit>
            <ci_upper_limit>43.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Good effects</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>52.0</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>44.4</ci_lower_limit>
            <ci_upper_limit>59.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>Good effects</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>53.0</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>45.4</ci_lower_limit>
            <ci_upper_limit>60.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Bad effects</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>20.4</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>13.6</ci_lower_limit>
            <ci_upper_limit>27.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Bad effects</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>5.04</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.76</ci_lower_limit>
            <ci_upper_limit>11.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Bad effects</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>7.28</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.487</ci_lower_limit>
            <ci_upper_limit>14.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>Bad effects</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>12.5</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.69</ci_lower_limit>
            <ci_upper_limit>19.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Any effects</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>75.4</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>67.2</ci_lower_limit>
            <ci_upper_limit>83.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Any effects</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>44.9</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>36.8</ci_lower_limit>
            <ci_upper_limit>53.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Any effects</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>56.8</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>48.7</ci_lower_limit>
            <ci_upper_limit>64.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>Any effects</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>64.8</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>56.7</ci_lower_limit>
            <ci_upper_limit>73.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>High</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>68.6</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>60.6</ci_lower_limit>
            <ci_upper_limit>76.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>High</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>34.4</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>26.4</ci_lower_limit>
            <ci_upper_limit>42.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>High</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>47.5</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>39.5</ci_lower_limit>
            <ci_upper_limit>55.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>High</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>58.4</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>50.4</ci_lower_limit>
            <ci_upper_limit>66.3</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PD: Maximal Drug Effects (Emax) VAS (Hallucinations)</title>
        <description>Drug Effects VAS Battery lists a series of measures that evaluate different effects of the abuse potential of the study drug. The hallucinations scale is presented meaning (I am hallucinating) and ranges from 0 not at all to 100 extremely. Emax is derived as the maximum score across all postdose time points for each participant. Median and interquartile range are reported for each treatment group.</description>
        <time_frame>Each Phase: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5,3, 3.5, 4, 4.5, 5, 6, 8, 12, 24 Hours Post Dose</time_frame>
        <population>All randomized participants who received at least one dose of study drug and had evaluable PD data, and completed the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo was administered orally in one of five treatment periods.</description>
          </group>
          <group group_id="O2">
            <title>Alprazolam - 2 mg</title>
            <description>2 mg of Alprazolam administered orally in one of five treatment periods</description>
          </group>
          <group group_id="O3">
            <title>Lasmiditan - 100 mg</title>
            <description>100 mg of lasmiditan administered orally in one of five treatment periods</description>
          </group>
          <group group_id="O4">
            <title>Lasmiditan - 200 mg</title>
            <description>200 mg of lasmiditan administered orally in one of five treatment periods</description>
          </group>
          <group group_id="O5">
            <title>Lasmiditan - 400 mg</title>
            <description>400 mg of lasmiditan administered orally in one of five treatment periods</description>
          </group>
        </group_list>
        <measure>
          <title>PD: Maximal Drug Effects (Emax) VAS (Hallucinations)</title>
          <description>Drug Effects VAS Battery lists a series of measures that evaluate different effects of the abuse potential of the study drug. The hallucinations scale is presented meaning (I am hallucinating) and ranges from 0 not at all to 100 extremely. Emax is derived as the maximum score across all postdose time points for each participant. Median and interquartile range are reported for each treatment group.</description>
          <population>All randomized participants who received at least one dose of study drug and had evaluable PD data, and completed the study.</population>
          <units>mm</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="53"/>
                <count group_id="O3" value="53"/>
                <count group_id="O4" value="53"/>
                <count group_id="O5" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="1.00"/>
                    <measurement group_id="O3" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O4" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O5" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0781</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>0</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0625</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>0</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0098</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>0</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PD: Minimum Drug Effects (Emin) Visual Analog Scale (VAS)</title>
        <description>Drug Effects VAS Battery lists a series of measures that evaluate different effects of the abuse potential of the study drug. The scales included: Alertness/Drowsiness (I am feeling) ranges from 0 very drowsy to 100 very alert. Agitation/Relaxation (my mood is) and ranges from 0 very relaxed to 100 very agitated. Emin is derived across all postdose time points for each participant. LS Mean was calculated using the linear mixed-effects model with period, sequence and treatment as fixed effects and participant as a random effect.</description>
        <time_frame>Each Phase:Predose, 0.25, 0.5, 1, 1.5, 2, 2.5,3, 3.5, 4, 4.5, 5, 6, 8, 12, 24 Hours Post Dose</time_frame>
        <population>All randomized participants who received at least one dose of study drug and had evaluable PD data, and completed the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo was administered orally in one of five treatment periods.</description>
          </group>
          <group group_id="O2">
            <title>Alprazolam - 2 mg</title>
            <description>2 mg of Alprazolam administered orally in one of five treatment periods</description>
          </group>
          <group group_id="O3">
            <title>Lasmiditan - 100 mg</title>
            <description>100 mg of lasmiditan administered orally in one of five treatment periods</description>
          </group>
          <group group_id="O4">
            <title>Lasmiditan - 200 mg</title>
            <description>200 mg of lasmiditan administered orally in one of five treatment periods</description>
          </group>
          <group group_id="O5">
            <title>Lasmiditan - 400 mg</title>
            <description>400 mg of lasmiditan administered orally in one of five treatment periods</description>
          </group>
        </group_list>
        <measure>
          <title>PD: Minimum Drug Effects (Emin) Visual Analog Scale (VAS)</title>
          <description>Drug Effects VAS Battery lists a series of measures that evaluate different effects of the abuse potential of the study drug. The scales included: Alertness/Drowsiness (I am feeling) ranges from 0 very drowsy to 100 very alert. Agitation/Relaxation (my mood is) and ranges from 0 very relaxed to 100 very agitated. Emin is derived across all postdose time points for each participant. LS Mean was calculated using the linear mixed-effects model with period, sequence and treatment as fixed effects and participant as a random effect.</description>
          <population>All randomized participants who received at least one dose of study drug and had evaluable PD data, and completed the study.</population>
          <units>mm</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="53"/>
                <count group_id="O3" value="53"/>
                <count group_id="O4" value="53"/>
                <count group_id="O5" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Alertness/drowsiness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.5" spread="1.97"/>
                    <measurement group_id="O2" value="12.5" spread="1.97"/>
                    <measurement group_id="O3" value="25.6" spread="1.97"/>
                    <measurement group_id="O4" value="22.9" spread="1.97"/>
                    <measurement group_id="O5" value="17.7" spread="1.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Agitation/relaxation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.1" spread="1.94"/>
                    <measurement group_id="O2" value="13.4" spread="1.94"/>
                    <measurement group_id="O3" value="24.6" spread="1.94"/>
                    <measurement group_id="O4" value="22.4" spread="1.94"/>
                    <measurement group_id="O5" value="15.4" spread="1.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Alertness/drowsiness</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-29.9</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-34.0</ci_lower_limit>
            <ci_upper_limit>-25.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Alertness/drowsiness</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-16.9</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-20.9</ci_lower_limit>
            <ci_upper_limit>-12.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Alertness/drowsiness</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-19.6</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-23.6</ci_lower_limit>
            <ci_upper_limit>-15.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>Alertness/drowsiness</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-24.8</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-28.8</ci_lower_limit>
            <ci_upper_limit>-20.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Agitation/relaxation</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-30.8</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-35.0</ci_lower_limit>
            <ci_upper_limit>-26.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Agitation/relaxation</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-19.5</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-23.7</ci_lower_limit>
            <ci_upper_limit>-15.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Agitation/relaxation</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-21.7</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-25.9</ci_lower_limit>
            <ci_upper_limit>-17.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>Agitation/relaxation</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-28.8</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-33.0</ci_lower_limit>
            <ci_upper_limit>-24.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PD: Mean Scores on Drug Similarity VAS Measures</title>
        <description>Participants marked a point on a 100-mm horizontal line that best represented their response to the given question. The endpoints of each electronic scale were marked with descriptive anchors on a scale from 0 to 100 (Fraser et al. 1961; Bond and Lader 1974; Bigelow 1991; Shram et al. 2010). In the &quot;How similar&quot; questions, ranges from 0 to 100 and a score of 0 indicates definitely not similar, and a score of 100 indicates definitely similar.</description>
        <time_frame>Each Phase: 24 Hours Post Dose</time_frame>
        <population>All randomized participants who received at least one dose of study drug, were familiar with each listed drug on the questionnaire and had evaluable data.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo - Qualification Phase</title>
            <description>Placebo was administered orally in one of 2 treatment periods.</description>
          </group>
          <group group_id="O2">
            <title>1 mg Alprazolam - Qualification Phase</title>
            <description>1 mg of Alprazolam was administered orally in one of 2 treatment periods.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo was administered orally in one of five treatment periods.</description>
          </group>
          <group group_id="O4">
            <title>2 mg Alprazolam</title>
            <description>2 mg of Alprazolam was administered orally in one of five treatment periods.</description>
          </group>
          <group group_id="O5">
            <title>Lasmiditan - 100 mg</title>
            <description>100 mg of lasmiditan administered orally in one of five treatment periods</description>
          </group>
          <group group_id="O6">
            <title>Lasmiditan - 200 mg</title>
            <description>200 mg of lasmiditan administered orally in one of five treatment periods</description>
          </group>
          <group group_id="O7">
            <title>Lasmiditan - 400 mg</title>
            <description>400 mg of lasmiditan administered orally in one of five treatment periods</description>
          </group>
        </group_list>
        <measure>
          <title>PD: Mean Scores on Drug Similarity VAS Measures</title>
          <description>Participants marked a point on a 100-mm horizontal line that best represented their response to the given question. The endpoints of each electronic scale were marked with descriptive anchors on a scale from 0 to 100 (Fraser et al. 1961; Bond and Lader 1974; Bigelow 1991; Shram et al. 2010). In the &quot;How similar&quot; questions, ranges from 0 to 100 and a score of 0 indicates definitely not similar, and a score of 100 indicates definitely similar.</description>
          <population>All randomized participants who received at least one dose of study drug, were familiar with each listed drug on the questionnaire and had evaluable data.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="95"/>
                <count group_id="O2" value="94"/>
                <count group_id="O3" value="55"/>
                <count group_id="O4" value="53"/>
                <count group_id="O5" value="55"/>
                <count group_id="O6" value="55"/>
                <count group_id="O7" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>How similar with cocaine /</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="28"/>
                    <count group_id="O4" value="27"/>
                    <count group_id="O5" value="28"/>
                    <count group_id="O6" value="28"/>
                    <count group_id="O7" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" spread="3.5"/>
                    <measurement group_id="O2" value="5.8" spread="10.6"/>
                    <measurement group_id="O3" value="2.2" spread="6.6"/>
                    <measurement group_id="O4" value="6.1" spread="13.6"/>
                    <measurement group_id="O5" value="2.7" spread="4.2"/>
                    <measurement group_id="O6" value="14.6" spread="26.3"/>
                    <measurement group_id="O7" value="12.5" spread="23.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>How similar with caffeine</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="73"/>
                    <count group_id="O3" value="43"/>
                    <count group_id="O4" value="42"/>
                    <count group_id="O5" value="44"/>
                    <count group_id="O6" value="44"/>
                    <count group_id="O7" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" spread="10.3"/>
                    <measurement group_id="O2" value="3.2" spread="6.0"/>
                    <measurement group_id="O3" value="1.5" spread="7.2"/>
                    <measurement group_id="O4" value="4.4" spread="9.7"/>
                    <measurement group_id="O5" value="2.2" spread="2.4"/>
                    <measurement group_id="O6" value="4.4" spread="9.8"/>
                    <measurement group_id="O7" value="4.1" spread="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>How similar to MDMA (Ectasy)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="31"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="18"/>
                    <count group_id="O4" value="17"/>
                    <count group_id="O5" value="17"/>
                    <count group_id="O6" value="18"/>
                    <count group_id="O7" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.7" spread="13.5"/>
                    <measurement group_id="O2" value="10.0" spread="20.4"/>
                    <measurement group_id="O3" value="1.4" spread="3.9"/>
                    <measurement group_id="O4" value="20.5" spread="23.7"/>
                    <measurement group_id="O5" value="10.6" spread="19.9"/>
                    <measurement group_id="O6" value="17.1" spread="28.2"/>
                    <measurement group_id="O7" value="18.7" spread="28.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>How similar to amphetamine or methamphetamine</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="24"/>
                    <count group_id="O3" value="16"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="16"/>
                    <count group_id="O6" value="17"/>
                    <count group_id="O7" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" spread="5.4"/>
                    <measurement group_id="O2" value="4.3" spread="6.3"/>
                    <measurement group_id="O3" value="2.4" spread="6.0"/>
                    <measurement group_id="O4" value="3.9" spread="5.5"/>
                    <measurement group_id="O5" value="2.3" spread="2.5"/>
                    <measurement group_id="O6" value="4.6" spread="4.8"/>
                    <measurement group_id="O7" value="4.4" spread="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>How similar to phencyclidine (PCP)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="3"/>
                    <count group_id="O5" value="3"/>
                    <count group_id="O6" value="3"/>
                    <count group_id="O7" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.0" spread="30.6"/>
                    <measurement group_id="O2" value="0.5" spread="1.0"/>
                    <measurement group_id="O3" value="0.0" spread="0.0"/>
                    <measurement group_id="O4" value="26.7" spread="40.3"/>
                    <measurement group_id="O5" value="1.3" spread="1.5"/>
                    <measurement group_id="O6" value="24.0" spread="37.3"/>
                    <measurement group_id="O7" value="32.3" spread="43.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>How similar to codeine or morphine use</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                    <count group_id="O2" value="82"/>
                    <count group_id="O3" value="49"/>
                    <count group_id="O4" value="47"/>
                    <count group_id="O5" value="49"/>
                    <count group_id="O6" value="49"/>
                    <count group_id="O7" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.4" spread="23.8"/>
                    <measurement group_id="O2" value="41.5" spread="35.1"/>
                    <measurement group_id="O3" value="8.1" spread="21.7"/>
                    <measurement group_id="O4" value="50.8" spread="31.2"/>
                    <measurement group_id="O5" value="30.9" spread="30.4"/>
                    <measurement group_id="O6" value="37.6" spread="31.7"/>
                    <measurement group_id="O7" value="45.9" spread="32.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>How similar to (lysergic acid diethylamide (LSD)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="6"/>
                    <count group_id="O6" value="7"/>
                    <count group_id="O7" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="3.9"/>
                    <measurement group_id="O2" value="4.1" spread="6.9"/>
                    <measurement group_id="O3" value="4.2" spread="6.6"/>
                    <measurement group_id="O4" value="6.2" spread="7.5"/>
                    <measurement group_id="O5" value="3.5" spread="4.6"/>
                    <measurement group_id="O6" value="5.9" spread="5.5"/>
                    <measurement group_id="O7" value="7.2" spread="8.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>How similar to nicotine</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                    <count group_id="O2" value="76"/>
                    <count group_id="O3" value="44"/>
                    <count group_id="O4" value="42"/>
                    <count group_id="O5" value="44"/>
                    <count group_id="O6" value="43"/>
                    <count group_id="O7" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" spread="11.8"/>
                    <measurement group_id="O2" value="5.1" spread="9.6"/>
                    <measurement group_id="O3" value="1.4" spread="5.5"/>
                    <measurement group_id="O4" value="3.8" spread="9.4"/>
                    <measurement group_id="O5" value="3.3" spread="11.0"/>
                    <measurement group_id="O6" value="3.6" spread="9.0"/>
                    <measurement group_id="O7" value="4.3" spread="8.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>How similar to cannabis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="92"/>
                    <count group_id="O2" value="91"/>
                    <count group_id="O3" value="53"/>
                    <count group_id="O4" value="51"/>
                    <count group_id="O5" value="53"/>
                    <count group_id="O6" value="53"/>
                    <count group_id="O7" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.8" spread="24.7"/>
                    <measurement group_id="O2" value="39.9" spread="33.5"/>
                    <measurement group_id="O3" value="8.9" spread="22.9"/>
                    <measurement group_id="O4" value="51.2" spread="30.3"/>
                    <measurement group_id="O5" value="29.9" spread="30.0"/>
                    <measurement group_id="O6" value="37.4" spread="29.6"/>
                    <measurement group_id="O7" value="41.7" spread="31.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>How similar to benzodiazepine</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="94"/>
                    <count group_id="O2" value="93"/>
                    <count group_id="O3" value="55"/>
                    <count group_id="O4" value="53"/>
                    <count group_id="O5" value="55"/>
                    <count group_id="O6" value="55"/>
                    <count group_id="O7" value="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.4" spread="32.4"/>
                    <measurement group_id="O2" value="75.9" spread="36.2"/>
                    <measurement group_id="O3" value="13.1" spread="30.6"/>
                    <measurement group_id="O4" value="88.1" spread="22.6"/>
                    <measurement group_id="O5" value="57.2" spread="40.3"/>
                    <measurement group_id="O6" value="66.9" spread="38.7"/>
                    <measurement group_id="O7" value="74.6" spread="31.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>How similar to mushrooms</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="7"/>
                    <count group_id="O4" value="7"/>
                    <count group_id="O5" value="7"/>
                    <count group_id="O6" value="8"/>
                    <count group_id="O7" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="0.0"/>
                    <measurement group_id="O2" value="2.7" spread="3.8"/>
                    <measurement group_id="O3" value="2.1" spread="5.2"/>
                    <measurement group_id="O4" value="3.7" spread="6.1"/>
                    <measurement group_id="O5" value="2.1" spread="2.1"/>
                    <measurement group_id="O6" value="3.8" spread="5.7"/>
                    <measurement group_id="O7" value="4.9" spread="6.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>How similar to heroin</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="2"/>
                    <count group_id="O6" value="2"/>
                    <count group_id="O7" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="0.0"/>
                    <measurement group_id="O2" value="17.8" spread="38.1"/>
                    <measurement group_id="O3" value="NA" spread="NA">Mean and standard deviation are not calculated due to N=2, minimum and maximum values are reported: minimum value is 0 and maximum value is 0.</measurement>
                    <measurement group_id="O4" value="NA" spread="NA">Mean and standard deviation are not calculated due to N=2, minimum and maximum values are reported: minimum value is 0 and maximum value is 79.</measurement>
                    <measurement group_id="O5" value="NA" spread="NA">Mean and standard deviation are not calculated due to N=2, minimum and maximum values are reported: minimum value is 0 and maximum value is 3.</measurement>
                    <measurement group_id="O6" value="NA" spread="NA">Mean and standard deviation are not calculated due to N=2, minimum and maximum values are reported: minimum value is 2 and maximum value is 60.</measurement>
                    <measurement group_id="O7" value="NA" spread="NA">Mean and standard deviation are not calculated due to N=2, minimum and maximum values are reported: minimum value is 2 and maximum value is 96.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From Baseline to Study Completion (Up to 2 months)</time_frame>
      <desc>All randomized participants who received at least one dose of study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>Qualification Phase - Placebo</title>
          <description>Placebo was administered orally.</description>
        </group>
        <group group_id="E2">
          <title>Qualification Phase - Alprazolam</title>
          <description>1 mg of alprazolam was administered orally.</description>
        </group>
        <group group_id="E3">
          <title>Treatment Phase - Placebo</title>
          <description>Placebo was administered orally in one of five treatment periods.</description>
        </group>
        <group group_id="E4">
          <title>Treatment Phase - 2 mg Alprazolam</title>
          <description>2 mg alprazolam was administered orally in one of five treatment periods.</description>
        </group>
        <group group_id="E5">
          <title>Treatment Phase - 100 mg Lasmiditan</title>
          <description>100 mg of Lasmiditan was administered orally in one of five treatment periods.</description>
        </group>
        <group group_id="E6">
          <title>Treatment Phase - 200 mg Lasmiditan</title>
          <description>200 mg of Lasmiditan was administered orally in one of five treatment periods.</description>
        </group>
        <group group_id="E7">
          <title>Treatment Phase - 400 mg Lasmiditan</title>
          <description>400 mg of Lasmiditan was administered orally in one of five treatment periods.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="95"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="95"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 20.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="95"/>
                <counts group_id="E2" subjects_affected="74" subjects_at_risk="94"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="55"/>
                <counts group_id="E4" subjects_affected="49" subjects_at_risk="53"/>
                <counts group_id="E5" subjects_affected="33" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="42" subjects_at_risk="55"/>
                <counts group_id="E7" subjects_affected="47" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Feeling of relaxation</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="95"/>
                <counts group_id="E2" events="20" subjects_affected="20" subjects_at_risk="94"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E4" events="12" subjects_affected="12" subjects_at_risk="53"/>
                <counts group_id="E5" events="6" subjects_affected="6" subjects_at_risk="55"/>
                <counts group_id="E6" events="4" subjects_affected="4" subjects_at_risk="55"/>
                <counts group_id="E7" events="4" subjects_affected="4" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="95"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="55"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Amnesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="95"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E4" events="10" subjects_affected="10" subjects_at_risk="53"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="95"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="53"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="55"/>
                <counts group_id="E6" events="6" subjects_affected="6" subjects_at_risk="55"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="95"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="94"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="55"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="53"/>
                <counts group_id="E5" events="4" subjects_affected="3" subjects_at_risk="55"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="55"/>
                <counts group_id="E7" events="4" subjects_affected="4" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="95"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="55"/>
                <counts group_id="E6" events="6" subjects_affected="6" subjects_at_risk="55"/>
                <counts group_id="E7" events="5" subjects_affected="5" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="95"/>
                <counts group_id="E2" events="52" subjects_affected="52" subjects_at_risk="94"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E4" events="45" subjects_affected="45" subjects_at_risk="53"/>
                <counts group_id="E5" events="18" subjects_affected="18" subjects_at_risk="55"/>
                <counts group_id="E6" events="22" subjects_affected="22" subjects_at_risk="55"/>
                <counts group_id="E7" events="30" subjects_affected="30" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="95"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="53"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="55"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Euphoric mood</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="95"/>
                <counts group_id="E2" events="22" subjects_affected="22" subjects_at_risk="94"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="55"/>
                <counts group_id="E4" events="23" subjects_affected="23" subjects_at_risk="53"/>
                <counts group_id="E5" events="14" subjects_affected="14" subjects_at_risk="55"/>
                <counts group_id="E6" events="27" subjects_affected="27" subjects_at_risk="55"/>
                <counts group_id="E7" events="25" subjects_affected="25" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Chief Medical Officer</name_or_title>
      <organization>Eli Lilly and Company</organization>
      <phone>(800) 545-5979</phone>
      <email>ClinicalTrials.gov@lilly.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03286218
org study id: 16853
secondary id: H8H-MC-LAHB
nct id: NCT03286218
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to assess the abuse potential of study drug lasmiditan.

      Lasmiditan will be compared to a marketed benzodiazepine, alprazolam (positive control), as
      well as to placebo (dummy substance that looks like lasmiditan or alprazolam without any
      active drug) to determine the potential for drug abuse. The dosages will be in tablet form
      and will be taken orally (by mouth).

      This study will last about 55 days, including screening. Screening will occur within 28 days
      prior to qualification phase.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Pharmacodynamics (PD): Maximal Effect Score (Emax) of Bipolar Drug Liking Visual Analog Scale (VAS) Scores
time frame: Each Phase: 24 Hours
description: The Emax of Bipolar Drug Liking VAS Scores were derived as the maximum at-the-moment Drug Liking VAS score where the time to Emax was the corresponding time point at which the maximum score occurred. The bipolar Drug Liking VAS is consistent with FDA Guidance (January 2017) such that placebo should produce a score between 40 and 60 representing neutral drug-liking (ie, neither like nor dislike); a score ranging from 0 to 100 and a score of 0 indicates strong disliking, and a score of 100 indicates strong liking. Least squares mean (LS mean) was calculated using a linear mixed-effects model, including period, sequence, and treatment as fixed effects, and subject as a random effect, was used to evaluate the hypothesis tests of primary interest (at-the-moment Drug Liking) at the Emax.
measure: Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan
time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours Post Dose
description: Pharmacokinetics (PK) defined as the maximum observed drug concentration (Cmax) of lasmiditan
measure: PK: Area Under the Curve of Lasmiditan From Zero to Infinity (AUC[0-∞])
time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours Post Dose
description: PK defined as the area under the curve of lasmiditan from zero to infinity (AUC[0-∞])
measure: PD: Maximal Drug Effects (Emax) Visual Analog Scale (VAS)
time frame: Each Phase: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5,3, 3.5, 4, 4.5, 5, 6, 8, 12, 24 Hours Post Dose
description: Drug Effects VAS Battery lists a series of measures that evaluate different effects of the abuse potential of the study drug. Scales include: Overall drug liking (overall, my liking for this drug is) and ranges from 0 definitely not to 100 definitely so. Take Drug Again (I would take this drug again) and ranges from 0 definitely not to 100 definitely so. Good effects (I can feel good drug effects) and ranges from 0 definitely not to 100 definitely so. Bad effects (I can feel bad drug effects) and ranges from 0 definitely not to 100 definitely so. High (I am feeling) and ranges from 0 not at all high to 100 extremely high. Emax is derived as the maximum score across all postdose time points for each participant. Least Square (LS) Mean is calculated using the linear mixed-effects model with period, sequence and treatment as fixed effects and participant as a random effect.
measure: PD: Maximal Drug Effects (Emax) VAS (Hallucinations)
time frame: Each Phase: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5,3, 3.5, 4, 4.5, 5, 6, 8, 12, 24 Hours Post Dose
description: Drug Effects VAS Battery lists a series of measures that evaluate different effects of the abuse potential of the study drug. The hallucinations scale is presented meaning (I am hallucinating) and ranges from 0 not at all to 100 extremely. Emax is derived as the maximum score across all postdose time points for each participant. Median and interquartile range are reported for each treatment group.
measure: PD: Minimum Drug Effects (Emin) Visual Analog Scale (VAS)
time frame: Each Phase:Predose, 0.25, 0.5, 1, 1.5, 2, 2.5,3, 3.5, 4, 4.5, 5, 6, 8, 12, 24 Hours Post Dose
description: Drug Effects VAS Battery lists a series of measures that evaluate different effects of the abuse potential of the study drug. The scales included: Alertness/Drowsiness (I am feeling) ranges from 0 very drowsy to 100 very alert. Agitation/Relaxation (my mood is) and ranges from 0 very relaxed to 100 very agitated. Emin is derived across all postdose time points for each participant. LS Mean was calculated using the linear mixed-effects model with period, sequence and treatment as fixed effects and participant as a random effect.
measure: PD: Mean Scores on Drug Similarity VAS Measures
time frame: Each Phase: 24 Hours Post Dose
description: Participants marked a point on a 100-mm horizontal line that best represented their response to the given question. The endpoints of each electronic scale were marked with descriptive anchors on a scale from 0 to 100 (Fraser et al. 1961; Bond and Lader 1974; Bigelow 1991; Shram et al. 2010). In the "How similar" questions, ranges from 0 to 100 and a score of 0 indicates definitely not similar, and a score of 100 indicates definitely similar.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo was administered orally in one of five treatment periods
arm group label: Alprazolam 2 milligram (mg)
arm group type: Active Comparator
description: 2 mg of alprazolam was administered orally in one of five treatment periods
arm group label: Lasmiditan 100 mg
arm group type: Experimental
description: 100 mg of lasmiditan was administered orally in one of five treatment periods
arm group label: Lasmiditan 200 mg
arm group type: Experimental
description: 200 mg of lasmiditan was administered orally in one of five treatment periods
arm group label: Lasmiditan 400 mg
arm group type: Experimental
description: 400 mg of lasmiditan was administered orally in one of five treatment periods
intervention type: Drug
intervention name: Lasmiditan
description: Administered orally
arm group label: Lasmiditan 100 mg
arm group label: Lasmiditan 200 mg
arm group label: Lasmiditan 400 mg
other name: LY573144
intervention type: Drug
intervention name: Alprazolam
description: Administered orally
arm group label: Alprazolam 2 milligram (mg)
intervention type: Drug
intervention name: Placebo
description: Administered orally
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: Study Director
affiliation: Eli Lilly and Company
facility: 
country: United States
responsible party type: Sponsor
mesh term: Substance-Related Disorders
mesh term: Alprazolam
mesh term: Lasmiditan
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 