<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/NCT02202213</url>
  </required_header>
  <id_info>
    <org_study_id>15698A</org_study_id>
    <nct_id>NCT02202213</nct_id>
  </id_info>
  <brief_title>Safety and Tolerability Study of Lu AF11167 After Repeated Dosing in Patients With Schizophrenia</brief_title>
  <official_title>Interventional, Randomised, Double-blind, Placebo Controlled, Multiple-dose Study Investigating the Safety, Tolerability, PK and PD Properties of Lu AF11167 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 safety and tolerability of Lu AF11167 in&#xD;
      patients with schizophrenia following various repeated dosing regimens of Lu AF11167 (alone&#xD;
      or as added treatment to risperidone).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 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 changes from baseline in safety variables (Adverse events, clinical safety laboratory tests, vital signs,respiratory rate, weight, body temperature and ECG)</measure>
    <time_frame>Screnning to day 25</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Columbia Suicide Severity Rating Scale (C-SSRS)</measure>
    <time_frame>Screening to day 25</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>Lu AF11167 hard capsules; 0.25, 0.5 and 1 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Part A: Lu AF11167 monotherapy Part B: Lu AF11167 adjunctive therapy to risperidone&#xD;
Three times daily oral dosing for 14 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Matching placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Daily oral dosing matching the experimental arm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Matching placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lu AF11167</intervention_name>
    <arm_group_label>Lu AF11167 hard capsules; 0.25, 0.5 and 1 mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Man or woman aged ≥18 years and ≤60 years with a body mass index (BMI) of ≥18.5 and&#xD;
             ≤38 m2&#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;
             the Screening Visit and Baseline Visit (Day -1)&#xD;
&#xD;
          -  PANSS total score ≤80 at the Screening Visit and the Baseline Visit (Day -1)&#xD;
&#xD;
          -  Score of 4 (moderate) of the following PANSS items at the Screening Visit and the&#xD;
             Baseline Visit (Day -1): P7 (hostility), G8 (uncooperativeness)&#xD;
&#xD;
          -  Minimal level of extrapyramidal signs, defined as a score ≤5 (moderately severe) in&#xD;
             any of the four Clinical Global Impression of Severity (CGI-S) items of the ESRS-A;&#xD;
             parkinsonism, akathisia, dystonia, and tardive dyskinesia at the Screening Visit and&#xD;
             the Baseline Visit&#xD;
&#xD;
          -  Willingness to be hospitalised for approximately 3 weeks after the Baseline Visit (Day&#xD;
             -1)&#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 increase in antipsychotic&#xD;
             medication (with reference to drug or dose) within the last 4 weeks&#xD;
&#xD;
        Other pre-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.com</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Parexel International</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>February 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>February 17, 2015</last_update_submitted>
  <last_update_submitted_qc>February 17, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 18, 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/NCT02202213
org study id: 15698A
nct id: NCT02202213
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the safety and tolerability of Lu AF11167 in
      patients with schizophrenia following various repeated dosing regimens of Lu AF11167 (alone
      or as added treatment to risperidone).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Absolute values and changes from baseline in safety variables (Adverse events, clinical safety laboratory tests, vital signs,respiratory rate, weight, body temperature and ECG)
time frame: Screnning to day 25
measure: Columbia Suicide Severity Rating Scale (C-SSRS)
time frame: Screening to day 25
arm group label: Lu AF11167 hard capsules; 0.25, 0.5 and 1 mg
arm group type: Experimental
description: Part A: Lu AF11167 monotherapy Part B: Lu AF11167 adjunctive therapy to risperidone
Three times daily oral dosing for 14 days.
arm group label: Matching placebo
arm group type: Placebo Comparator
description: Daily oral dosing matching the experimental arm.
intervention type: Drug
intervention name: Placebo
arm group label: Matching placebo
intervention type: Drug
intervention name: Lu AF11167
arm group label: Lu AF11167 hard capsules; 0.25, 0.5 and 1 mg
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.com
facility: 
country: United States
responsible party type: Sponsor
mesh term: Schizophrenia