<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/NCT02202226</url>
  </required_header>
  <id_info>
    <org_study_id>14754A</org_study_id>
    <nct_id>NCT02202226</nct_id>
  </id_info>
  <brief_title>Safety and Tolerability Study of Lu AF35700 After Repeated Dosing in Patients With Schizophrenia</brief_title>
  <official_title>Interventional, Randomised, Double-blind, Placebo-controlled, Sequential Group, Multiple Dose Study Investigating the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of Lu AF35700 in Patients With Schizophrenia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>H. Lundbeck A/S</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>H. Lundbeck A/S</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the tolerability and safety of Lu AF35700 after&#xD;
      repeated oral dosing to patients with schizophrenia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <primary_completion_date type="Actual">February 2015</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Absolute values and change from baseline in safety variables (Adverse events, clinical safety laboratory tets, vital signs, weight, and ECG)</measure>
    <time_frame>Screening to day 78 (up to 8 weeks after last dose)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in AIMS, BARS and SAS Total score</measure>
    <time_frame>Baseline to day 21</time_frame>
    <description>Abnormal movement rating scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Columbia Suicide Severity Rating Scale (C-SSRS)</measure>
    <time_frame>Sceening to day 78 (up to 8 weeks after last dose)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Day 21 area under the Lu AF35700 and Lu AF36152 plasma concentration-time curve from 0-24 hours post dose (AUC0-tau) in a daily dosing regime</measure>
    <time_frame>Day 21 in the dosing period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum observed concentration (Cmax) of Lu AF35700 and Lu AF36152</measure>
    <time_frame>Day 1 and 21 in the dosing period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Half-lives (t½) of Lu AF35700 and Lu AF36152</measure>
    <time_frame>Day 1 and 21 in the dosing period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Day 14-21 area under the Lu AF35700 and LuAF36152 plasma-concentration-time curve from 0-168 hours post-dose (AUCtau) in a weekly dosing regimen</measure>
    <time_frame>Day 14-21 in the dosing period</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">96</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>Lu AF35700 oral solution (1 mg/mL)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Planned daily doses range from 5 mg/day to 30 mg/day for 3 weeks. Weekly doses up to 75 mg/week for 3 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Matching placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Oral solution</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lu AF35700</intervention_name>
    <arm_group_label>Lu AF35700 oral solution (1 mg/mL)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Matching placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men or women between 18 and 60 years (extremes included)&#xD;
&#xD;
          -  BMI of ≤38&#xD;
&#xD;
          -  Primary diagnosis of schizophrenia according to DSM-IV-TR™ (codes 295.10, 295.20,&#xD;
             295.30, 295.90)&#xD;
&#xD;
          -  Clinical Global Impression - Severity of Illness (CGI-S) score ≤4 (moderately ill) at&#xD;
             screening and baseline&#xD;
&#xD;
          -  PANSS total score ≤80&#xD;
&#xD;
          -  Score ≤4 (moderate) on the following PANSS items at screening and safety baseline: P7&#xD;
             (hostility), G8 (uncooperativeness)&#xD;
&#xD;
          -  Willing to be hospitalised for 4 to 5 weeks after the Safety Baseline Visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The patient experienced an acute exacerbation requiring hospitalization within the&#xD;
             last 6 months&#xD;
&#xD;
          -  The patient experienced an acute exacerbation requiring change in antipsychotic&#xD;
             medication (with reference to drug or dose) within the last 4 weeks&#xD;
&#xD;
          -  The patient has a diagnosis or history of substance dependence (except nicotine) or&#xD;
             substance abuse according to DSM-IV-TR® criteria ≤3 months prior to screening&#xD;
&#xD;
          -  The patient smokes &gt;20 cigarettes per day&#xD;
&#xD;
        Other protocol-defined inclusion and exclusion criteria may apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Email contact via H.Lundbeck A/S</last_name>
    <role>Study Director</role>
    <affiliation>LundbeckClinicalTrials@Lundbeck.com</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>PAREXEL Phase I Unit</name>
      <address>
        <city>Glendale</city>
        <state>California</state>
        <zip>91206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>July 25, 2014</study_first_submitted>
  <study_first_submitted_qc>July 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 28, 2014</study_first_posted>
  <last_update_submitted>March 4, 2015</last_update_submitted>
  <last_update_submitted_qc>March 4, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 6, 2015</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>Schizophrenia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02202226
org study id: 14754A
nct id: NCT02202226
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the tolerability and safety of Lu AF35700 after
      repeated oral dosing to patients with schizophrenia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Absolute values and change from baseline in safety variables (Adverse events, clinical safety laboratory tets, vital signs, weight, and ECG)
time frame: Screening to day 78 (up to 8 weeks after last dose)
measure: Change from baseline in AIMS, BARS and SAS Total score
time frame: Baseline to day 21
description: Abnormal movement rating scale
measure: Columbia Suicide Severity Rating Scale (C-SSRS)
time frame: Sceening to day 78 (up to 8 weeks after last dose)
measure: Day 21 area under the Lu AF35700 and Lu AF36152 plasma concentration-time curve from 0-24 hours post dose (AUC0-tau) in a daily dosing regime
time frame: Day 21 in the dosing period
measure: Maximum observed concentration (Cmax) of Lu AF35700 and Lu AF36152
time frame: Day 1 and 21 in the dosing period
measure: Half-lives (t½) of Lu AF35700 and Lu AF36152
time frame: Day 1 and 21 in the dosing period
measure: Day 14-21 area under the Lu AF35700 and LuAF36152 plasma-concentration-time curve from 0-168 hours post-dose (AUCtau) in a weekly dosing regimen
time frame: Day 14-21 in the dosing period
arm group label: Lu AF35700 oral solution (1 mg/mL)
arm group type: Experimental
description: Planned daily doses range from 5 mg/day to 30 mg/day for 3 weeks. Weekly doses up to 75 mg/week for 3 weeks.
arm group label: Matching placebo
arm group type: Placebo Comparator
description: Oral solution
intervention type: Drug
intervention name: Lu AF35700
arm group label: Lu AF35700 oral solution (1 mg/mL)
intervention type: Drug
intervention name: Placebo
arm group label: Matching placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Email contact via H.Lundbeck A/S
role: Study Director
affiliation: LundbeckClinicalTrials@Lundbeck.com
facility: 
country: United States
responsible party type: Sponsor
mesh term: Schizophrenia