<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/NCT02186769</url>
  </required_header>
  <id_info>
    <org_study_id>LY03004/CT-USA-104</org_study_id>
    <nct_id>NCT02186769</nct_id>
  </id_info>
  <brief_title>An Randomized Open-Label PK Study of LY03004 Compared to Risperdal® Consta® in Stable Patients With Schizophrenia or Schizoaffective Disorder</brief_title>
  <official_title>A Randomized, Open-Label Pharmacokinetic Study of LY03004 Compared to Risperdal® Consta® Following a Single Intramuscular Injection at 25 mg or 50 mg in Stable Patients With Schizophrenia and/or Schizoaffective Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Luye Pharma Group Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Luye Pharma Group Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A review of the amount of drug in your blood over time.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cmax for the Pharmacokinetics (PK) of Risperdal® Consta®</measure>
    <time_frame>57 days</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Schizophrenia</condition>
  <condition>Schizoaffective Disorder</condition>
  <arm_group>
    <arm_group_label>Risperdal® Consta®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>25 Mg or 50 mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>L03004</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>25 mg or 50 mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Risperdal® Consta®</intervention_name>
    <arm_group_label>Risperdal® Consta®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LY03004</intervention_name>
    <arm_group_label>L03004</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female patients aged 18 to 65 years old;&#xD;
&#xD;
          2. Patients must have a DSM-IV diagnosis of schizophrenia or schizoaffective disorder&#xD;
             based on the Mini-International Neuropsychiatric Interview (MINI);&#xD;
&#xD;
          3. Patients must be clinically stable on antipsychotic medications other than risperidone&#xD;
             or paliperidone or clozapine for at least 4 weeks prior to screening, based on&#xD;
             clinical assessments and a Positive and Negative Syndrome Scale (PANSS) total score&#xD;
             less than or equal 70 at screening visit;&#xD;
&#xD;
          4. Patients with a Body Mass Index in range of 18.0 to 35.0;&#xD;
&#xD;
          5. Patients with an Informed consent form signed by the patient or legally acceptable&#xD;
             representative&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with a mental disorders other than schizophrenia or schizoaffective disorder,&#xD;
             according to the DSM-IV;&#xD;
&#xD;
          2. Patients who received oral risperidone or paliperidone or clozapine within 14 days&#xD;
             prior to screening, or Risperdal® Consta® within 100 days or LY03004 within 80 days&#xD;
             prior to screening or paliperidone palmitate within 10 months prior to screening;&#xD;
&#xD;
          3. Patients with neuroleptic malignant syndrome or physical fatigue associated with&#xD;
             dehydration or malnutrition;&#xD;
&#xD;
          4. Patients who pose a significant risk of a suicide attempt based on history,&#xD;
             investigator's judgment or have answered &quot;yes&quot; on the questions 4 or 5 for current or&#xD;
             past 30 days on the Baseline/Screening Version of the Columbia Suicide Severity Rating&#xD;
             Scale (C-SSRS).&#xD;
&#xD;
          5. Patients with a history of sensitivity to akathisia and other EPS, especially with&#xD;
             previous use of risperidone or paliperidone.&#xD;
&#xD;
          6. Patients with uncontrolled diabetes mellitus as indicated by a HbA1c level greater&#xD;
             than or equal 7%;&#xD;
&#xD;
          7. Patients with a history of or currently having epilepsy or convulsion disorders;&#xD;
&#xD;
          8. Patients who have had electroconvulsive therapy within the past 2 months prior to&#xD;
             screening;&#xD;
&#xD;
          9. Patients who used medication known to be an inducer or inhibitor for CYP 2D6 less than&#xD;
             2 weeks prior to screening;&#xD;
&#xD;
         10. Patients with a history of allergic reaction to risperidone or to the excipients of&#xD;
             LY03004;&#xD;
&#xD;
         11. Patients who have met DSM-IV-TR criteria for substance abuse or dependence with the&#xD;
             exception of caffeine or nicotine in the past 6 months prior to screening&#xD;
&#xD;
         12. Patients with a history of clinically relevant cardiac arrhythmia's, cardiovascular&#xD;
             disease, thyrotoxicosis, parkinsonism, or hemorrhagic diathesis;&#xD;
&#xD;
         13. Patients who are currently taking medications with primarily CNS activities such as&#xD;
             antidepressants, mood stablizers or anticonvulsants;&#xD;
&#xD;
         14. Patients who have participated in a clinical trial of another investigational drug&#xD;
             within 30 days prior to screening;&#xD;
&#xD;
         15. Female patients who are pregnant or are breastfeeding or are of childbearing potential&#xD;
             without adequate contraception.&#xD;
&#xD;
         16. Patients who have any clinically relevant hepatic, renal and cardiac dysfunction, or&#xD;
             other medical condition or laboratory abnormality, which in the judgment of the&#xD;
             investigator would interfere with the subject's ability to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Neuropsychiatric Research Center of Orange County</name>
      <address>
        <city>Orange County</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community Clinical Research Inc</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78754</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>June 4, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>June 17, 2015</last_update_submitted>
  <last_update_submitted_qc>June 17, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 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>
    <mesh_term>Psychotic Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Risperidone</mesh_term>
  </intervention_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/NCT02186769
org study id: LY03004/CT-USA-104
nct id: NCT02186769
lead sponsor: 
has dmc: No
A review of the amount of drug in your blood over time.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cmax for the Pharmacokinetics (PK) of Risperdal® Consta®
time frame: 57 days
arm group label: Risperdal® Consta®
arm group type: Active Comparator
description: 25 Mg or 50 mg
arm group label: L03004
arm group type: Experimental
description: 25 mg or 50 mg
intervention type: Drug
intervention name: Risperdal® Consta®
arm group label: Risperdal® Consta®
intervention type: Drug
intervention name: LY03004
arm group label: L03004
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Schizophrenia
mesh term: Psychotic Disorders
mesh term: Risperidone