<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/NCT03037203</url>
  </required_header>
  <id_info>
    <org_study_id>JZP166-201</org_study_id>
    <nct_id>NCT03037203</nct_id>
  </id_info>
  <brief_title>A 4-Week Study of the Safety, Efficacy, and Pharmacokinetics of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in Subjects With Parkinson's Disease and Excessive Sleepiness</brief_title>
  <official_title>A 4-Week, Double-blind, Placebo-controlled, Randomized, Multicenter, Crossover Study of the Safety, Efficacy, and Pharmacokinetics of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in Subjects With Parkinson's Disease and Excessive Sleepiness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jazz Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jazz Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a 4-week, multicenter, randomized, double-blind, placebo-controlled, ascending&#xD;
      dose, 4-period crossover study designed to evaluate the safety, tolerability, efficacy, and&#xD;
      PK of JZP-110 (75, 150, and 300 mg) in the treatment of excessive sleepiness in adult&#xD;
      subjects with idiopathic PD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">August 2018</completion_date>
  <primary_completion_date type="Actual">August 2018</primary_completion_date>
  <phase>Phase 2</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>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Early Discontinuation</measure>
    <time_frame>Up to Day 35</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score</measure>
    <time_frame>Baseline to Weeks 1, 2, 3, and 4</time_frame>
    <description>Change from Baseline ESS defined in terms of change from study baseline (prior to first dose in Period 1) to the end of each Treatment Period (Weeks 1, 2, 3, and 4).&#xD;
The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions, asking subjects how likely they would be to doze off or fall asleep in different situations. Responses range from 0 = would never doze to 3 = high chance of dozing. Higher scores represent greater severity of excessive sleepiness. The total score ranges from 0 - 24, with higher scores representing greater severity of excessive sleepiness.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change From Baseline in the Mean Sleep Latency Time (in Minutes) on the Maintenance of Wakefulness Test (MWT)</measure>
    <time_frame>Baseline to Weeks 1, 2, 3, and 4</time_frame>
    <description>Change from Baseline mean sleep latency (in minutes) on the MWT defined in terms of change from study baseline (prior to first dose in Period 1) to the end of each Treatment Period (Weeks 1, 2, 3, and 4).&#xD;
The MWT is the standard objective measure of an individual's ability to remain awake during the daytime in a darkened, quiet environment. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicated greater ability to stay awake.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Excessive Sleepiness</condition>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>JZP-110 and Placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>JZP-110 and Placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm C</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JZP-110</intervention_name>
    <description>75 mg, 150 mg, 300 mg</description>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_label>Arm B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_label>Arm B</arm_group_label>
    <arm_group_label>Arm C</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of idiopathic PD according to the UK PDS Brain Bank Criteria.&#xD;
&#xD;
          2. Hoehn and Yahr stage 1, 2, or 3.&#xD;
&#xD;
          3. Screening and Baseline ESS scores &gt;11.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of other degenerative Parkinsonian syndromes (e.g., progressive supranuclear&#xD;
             palsy, multiple system atrophy [MSA], or dementia with Lewy bodies [DLB]).&#xD;
&#xD;
          2. Usual nightly time in bed of &lt;6 hours, including the night before the Baseline visit.&#xD;
&#xD;
          3. Untreated or inadequately treated moderate to severe OSA.&#xD;
&#xD;
          4. Has evidence at screening of severe cognitive impairment or has cognitive impairment&#xD;
             that in the opinion of the investigator would prevent completion of study procedures&#xD;
             or the ability to provide informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Millie Gottwald, PharmD</last_name>
    <role>Study Director</role>
    <affiliation>Jazz Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Southern California Institute For Respiratory Diseases, Inc.</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pacific Research Network, Inc</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alpine Clinical Research Center</name>
      <address>
        <city>Boulder</city>
        <state>Colorado</state>
        <zip>80301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Movement Disorders Center, PC</name>
      <address>
        <city>Englewood</city>
        <state>Colorado</state>
        <zip>80113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parkinson's Disease and Movement Disorders Center of Boca Raton</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33486</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PAB Clinical Research</name>
      <address>
        <city>Brandon</city>
        <state>Florida</state>
        <zip>33511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MD Clinical</name>
      <address>
        <city>Hallandale Beach</city>
        <state>Florida</state>
        <zip>33009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>QPS MRA (Miami Research Associates)</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bioclinica Research</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>USF Health Byrd Institute</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33613</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kansas Medical Center Research Institute, Inc.</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Sleep &amp; Wake Disorders</name>
      <address>
        <city>Chevy Chase</city>
        <state>Maryland</state>
        <zip>20815</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>QUEST Research Institute</name>
      <address>
        <city>Farmington Hills</city>
        <state>Michigan</state>
        <zip>48334</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Neurophysiology Services, P.C.</name>
      <address>
        <city>Sterling Heights</city>
        <state>Michigan</state>
        <zip>48314</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Medical Center - West Bloomfield</name>
      <address>
        <city>West Bloomfield</city>
        <state>Michigan</state>
        <zip>48322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Lukes Hospital Medical Center</name>
      <address>
        <city>Chesterfield</city>
        <state>Missouri</state>
        <zip>63017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montefiore Sleep-Wake Disorders Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Strong Sleep Disorders Center</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14618</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lynn Health Science Institute</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parkinson's Disease Research Unit - Thomas Jefferson University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SleepMed of South Carolina</name>
      <address>
        <city>Columbia</city>
        <state>South Carolina</state>
        <zip>29201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Villages at Vanderbilt</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Evergreen Hospital Medical Center</name>
      <address>
        <city>Kirkland</city>
        <state>Washington</state>
        <zip>98034</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Premier Clinical Research - Sherman</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>January 23, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <results_first_submitted>August 16, 2019</results_first_submitted>
  <results_first_submitted_qc>January 3, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">January 9, 2020</results_first_posted>
  <last_update_submitted>January 3, 2020</last_update_submitted>
  <last_update_submitted_qc>January 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 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>Parkinson Disease</mesh_term>
    <mesh_term>Disorders of Excessive Somnolence</mesh_term>
    <mesh_term>Sleepiness</mesh_term>
  </condition_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>January 26, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/03/NCT03037203/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>October 10, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/03/NCT03037203/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Treatment Sequence A</title>
          <description>Subjects in Treatment Sequence A were assigned the following from Period 1, Week 1 through Period 4, Week 4: Placebo, JZP-110 75 mg, JZP 110 150 mg, and JZP 110 300 mg.</description>
        </group>
        <group group_id="P2">
          <title>Treatment Sequence B</title>
          <description>Subjects in Treatment Sequence B were assigned the following from Period 1, Week 1 through Period 4, Week 4: JZP-110 75 mg, JZP 110 150 mg, JZP 110 300 mg, and Placebo.</description>
        </group>
        <group group_id="P3">
          <title>Treatment Sequence C</title>
          <description>Subjects in Treatment Sequence C were assigned Placebo for each Period.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="28"/>
                <participants group_id="P3" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="26"/>
                <participants group_id="P3" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Treatment Sequence A</title>
          <description>Subjects in Treatment Sequence A were assigned the following from Period 1, Week 1 through Period 4, Week 4: Placebo, JZP-110 75 mg, JZP 110 150 mg, and JZP 110 300 mg.</description>
        </group>
        <group group_id="B2">
          <title>Treatment Sequence B</title>
          <description>Subjects in Treatment Sequence B were assigned the following from Period 1, Week 1 through Period 4, Week 4: JZP-110 75 mg, JZP 110 150 mg, JZP 110 300 mg, and Placebo.</description>
        </group>
        <group group_id="B3">
          <title>Treatment Sequence C</title>
          <description>Subjects in Treatment Sequence C were assigned Placebo for each Period.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="28"/>
            <count group_id="B2" value="28"/>
            <count group_id="B3" value="10"/>
            <count group_id="B4" value="66"/>
          </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="65.9" spread="7.64"/>
                    <measurement group_id="B2" value="62.9" spread="8.75"/>
                    <measurement group_id="B3" value="65.4" spread="9.75"/>
                    <measurement group_id="B4" value="64.6" spread="8.45"/>
                  </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="10"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="45"/>
                  </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="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="60"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Early Discontinuation</title>
        <time_frame>Up to Day 35</time_frame>
        <population>The Safety population includes all subjects who received at least one dose of study drug</population>
        <group_list>
          <group group_id="O1">
            <title>JZP-110 75mg</title>
            <description>The JZP-110 75 mg group consists of all subjects in the Safety population who also received at least 1 dose of 75 mg from Sequences A (28) and B (28), with a total of 56 subjects.</description>
          </group>
          <group group_id="O2">
            <title>JZP-110 150mg</title>
            <description>The JZP-110 150 mg group consists of all subjects in the Safety population who also received at least 1 dose of 150 mg from Sequences A (28) and B (27), with a total of 55 subjects.</description>
          </group>
          <group group_id="O3">
            <title>JZP-110 300mg</title>
            <description>The JZP-110 300 mg group consists of all subjects in the Safety population who also received at least 1 dose of 300 mg from Sequences A (28) and B (26), with a total of 54 subjects.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>The Placebo group consists of all subjects in the Safety population who also received at least 1 dose of Placebo from Sequences A (28), B (26), and C (10) with a total of 64 subjects.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Early Discontinuation</title>
          <population>The Safety population includes all subjects who received at least one dose of study drug</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
                <count group_id="O2" value="55"/>
                <count group_id="O3" value="54"/>
                <count group_id="O4" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score</title>
        <description>Change from Baseline ESS defined in terms of change from study baseline (prior to first dose in Period 1) to the end of each Treatment Period (Weeks 1, 2, 3, and 4).&#xD;
The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions, asking subjects how likely they would be to doze off or fall asleep in different situations. Responses range from 0 = would never doze to 3 = high chance of dozing. Higher scores represent greater severity of excessive sleepiness. The total score ranges from 0 - 24, with higher scores representing greater severity of excessive sleepiness.</description>
        <time_frame>Baseline to Weeks 1, 2, 3, and 4</time_frame>
        <population>The modified Intent-to-Treat population is defined as all randomized subjects who took at least one dose of study drug and have a Baseline and at least one post-Baseline efficacy assessment. Two subjects who did not have at least one post-baseline efficacy data were excluded from the mITT Population, resulting in a total of 64 subjects.</population>
        <group_list>
          <group group_id="O1">
            <title>JZP-110 75mg</title>
            <description>The JZP-110 75 mg group consisted of all subjects in the mITT population from Sequences A (28 subjects) and B (27 subjects), for a total of 55 subjects.</description>
          </group>
          <group group_id="O2">
            <title>JZP-110 150mg</title>
            <description>The JZP-110 150 mg group consisted of all subjects in the mITT population from Sequences A (28 subjects) and B (27 subjects), for a total of 55 subjects.</description>
          </group>
          <group group_id="O3">
            <title>JZP-110 300mg</title>
            <description>The JZP-110 300 mg group consisted of all subjects in the mITT population from Sequences A (28 subjects) and B (27 subjects), for a total of 55 subjects.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>The Placebo group includes all subjects in the mITT population from Sequences A, B, and C - 64 subjects in total.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score</title>
          <description>Change from Baseline ESS defined in terms of change from study baseline (prior to first dose in Period 1) to the end of each Treatment Period (Weeks 1, 2, 3, and 4).&#xD;
The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions, asking subjects how likely they would be to doze off or fall asleep in different situations. Responses range from 0 = would never doze to 3 = high chance of dozing. Higher scores represent greater severity of excessive sleepiness. The total score ranges from 0 - 24, with higher scores representing greater severity of excessive sleepiness.</description>
          <population>The modified Intent-to-Treat population is defined as all randomized subjects who took at least one dose of study drug and have a Baseline and at least one post-Baseline efficacy assessment. Two subjects who did not have at least one post-baseline efficacy data were excluded from the mITT Population, resulting in a total of 64 subjects.</population>
          <units>score on a scale</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="55"/>
                <count group_id="O2" value="55"/>
                <count group_id="O3" value="55"/>
                <count group_id="O4" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.82" spread="0.67"/>
                    <measurement group_id="O2" value="-5.04" spread="0.70"/>
                    <measurement group_id="O3" value="-5.72" spread="0.68"/>
                    <measurement group_id="O4" value="-4.78" spread="0.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline in the Mean Sleep Latency Time (in Minutes) on the Maintenance of Wakefulness Test (MWT)</title>
        <description>Change from Baseline mean sleep latency (in minutes) on the MWT defined in terms of change from study baseline (prior to first dose in Period 1) to the end of each Treatment Period (Weeks 1, 2, 3, and 4).&#xD;
The MWT is the standard objective measure of an individual's ability to remain awake during the daytime in a darkened, quiet environment. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicated greater ability to stay awake.</description>
        <time_frame>Baseline to Weeks 1, 2, 3, and 4</time_frame>
        <population>The MWT analysis evaluated results from subjects in the mITT population who were in Group 1 only (N=53 subjects).</population>
        <group_list>
          <group group_id="O1">
            <title>JZP-110 75mg</title>
            <description>The JZP-110 75 mg group consisted of all subjects in the mITT population in Group 1 from Sequences A (24 subjects) and B (23 subjects), with a total of 47 subjects.</description>
          </group>
          <group group_id="O2">
            <title>JZP-110 150mg</title>
            <description>The JZP-110 150 mg group consisted of all subjects in the mITT population in Group 1 from Sequences A (24 subjects) and B (23 subjects), with a total of 47 subjects.</description>
          </group>
          <group group_id="O3">
            <title>JZP-110 300mg</title>
            <description>The JZP-110 300 mg group consisted of all subjects in the mITT population in Group 1 from Sequences A (24 subjects) and B (23 subjects), with a total of 47 subjects.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>The Placebo group includes all subjects in the mITT population in Group 1 from Sequences A, B, and C - 53 subjects in total.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Mean Sleep Latency Time (in Minutes) on the Maintenance of Wakefulness Test (MWT)</title>
          <description>Change from Baseline mean sleep latency (in minutes) on the MWT defined in terms of change from study baseline (prior to first dose in Period 1) to the end of each Treatment Period (Weeks 1, 2, 3, and 4).&#xD;
The MWT is the standard objective measure of an individual's ability to remain awake during the daytime in a darkened, quiet environment. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicated greater ability to stay awake.</description>
          <population>The MWT analysis evaluated results from subjects in the mITT population who were in Group 1 only (N=53 subjects).</population>
          <units>minutes</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="47"/>
                <count group_id="O2" value="47"/>
                <count group_id="O3" value="47"/>
                <count group_id="O4" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4289" spread="2.1254"/>
                    <measurement group_id="O2" value="2.6721" spread="2.1961"/>
                    <measurement group_id="O3" value="6.8133" spread="2.1351"/>
                    <measurement group_id="O4" value="1.7670" spread="1.8479"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to Day 35</time_frame>
      <desc>The Safety population includes all subjects who received at least one dose of study drug</desc>
      <group_list>
        <group group_id="E1">
          <title>JZP-110 75 mg</title>
          <description>The JZP-110 75 mg group consists of all subjects in the Safety population who also received at least 1 dose of 75 mg from Sequences A (28) and B (28), with a total of 56 subjects.</description>
        </group>
        <group group_id="E2">
          <title>JZP-110 150 mg</title>
          <description>The JZP-110 150 mg group consists of all subjects in the Safety population who also received at least 1 dose of 150 mg from Sequences A (28) and B (27), with a total of 55 subjects.</description>
        </group>
        <group group_id="E3">
          <title>JZP-110 300 mg</title>
          <description>The JZP-110 300 mg group consists of all subjects in the Safety population who also received at least 1 dose of 300 mg from Sequences A (28) and B (26), with a total of 54 subjects.</description>
        </group>
        <group group_id="E4">
          <title>Placebo</title>
          <description>The Placebo group consists of all subjects in the Safety population who also received at least 1 dose of Placebo from Sequences A (28), B (26), and C (10) with a total of 64 subjects.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (18.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="56"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (18.0)</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="4" subjects_at_risk="56"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="55"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="55"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
              </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 sponsor can review trial results communications prior to public release and can embargo such communications for a period of at least 60 days from the time submitted to sponsor for review. If requested by sponsor, the PI will withhold publication for up to an additional 30 days. Furthermore, the first publication of study results must be a joint publication of all study sites unless a joint manuscript has not been submitted for publication within 12 months of completion of the study.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Director, Disclosure &amp; Transparency</name_or_title>
      <organization>Jazz Pharmaceuticals</organization>
      <phone>2159707145</phone>
      <email>ClinicalTrialDisclosure@JazzPharma.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/NCT03037203
org study id: JZP166-201
nct id: NCT03037203
lead sponsor: 
has dmc: No
This study is a 4-week, multicenter, randomized, double-blind, placebo-controlled, ascending
      dose, 4-period crossover study designed to evaluate the safety, tolerability, efficacy, and
      PK of JZP-110 (75, 150, and 300 mg) in the treatment of excessive sleepiness in adult
      subjects with idiopathic PD.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Early Discontinuation
time frame: Up to Day 35
measure: Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score
time frame: Baseline to Weeks 1, 2, 3, and 4
description: Change from Baseline ESS defined in terms of change from study baseline (prior to first dose in Period 1) to the end of each Treatment Period (Weeks 1, 2, 3, and 4).
The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions, asking subjects how likely they would be to doze off or fall asleep in different situations. Responses range from 0 = would never doze to 3 = high chance of dozing. Higher scores represent greater severity of excessive sleepiness. The total score ranges from 0 - 24, with higher scores representing greater severity of excessive sleepiness.
measure: Change From Baseline in the Mean Sleep Latency Time (in Minutes) on the Maintenance of Wakefulness Test (MWT)
time frame: Baseline to Weeks 1, 2, 3, and 4
description: Change from Baseline mean sleep latency (in minutes) on the MWT defined in terms of change from study baseline (prior to first dose in Period 1) to the end of each Treatment Period (Weeks 1, 2, 3, and 4).
The MWT is the standard objective measure of an individual's ability to remain awake during the daytime in a darkened, quiet environment. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicated greater ability to stay awake.
arm group label: Arm A
arm group type: Experimental
description: JZP-110 and Placebo
arm group label: Arm B
arm group type: Experimental
description: JZP-110 and Placebo
arm group label: Arm C
arm group type: Placebo Comparator
description: Placebo
intervention type: Drug
intervention name: JZP-110
description: 75 mg, 150 mg, 300 mg
arm group label: Arm A
arm group label: Arm B
intervention type: Other
intervention name: Placebo
arm group label: Arm A
arm group label: Arm B
arm group label: Arm C
criteria: 
gender: All
minimum age: 35 Years
maximum age: 80 Years
healthy volunteers: No
last name: Millie Gottwald, PharmD
role: Study Director
affiliation: Jazz Pharmaceuticals
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country: United States
responsible party type: Sponsor
mesh term: Parkinson Disease
mesh term: Disorders of Excessive Somnolence
mesh term: Sleepiness
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 