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An Randomized Open-Label PK Study of LY03004 Compared to Risperdal® Consta® in Stable Patients With Schizophrenia or Schizoaffective Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02186769
Recruitment Status : Completed
First Posted : July 10, 2014
Last Update Posted : June 18, 2015
Information provided by (Responsible Party):
Luye Pharma Group Ltd.

Brief Summary:
A review of the amount of drug in your blood over time.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Drug: Risperdal® Consta® Drug: LY03004 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : July 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Risperidone

Arm Intervention/treatment
Active Comparator: Risperdal® Consta®
25 Mg or 50 mg
Drug: Risperdal® Consta®
Experimental: L03004
25 mg or 50 mg
Drug: LY03004

Primary Outcome Measures :
  1. Cmax for the Pharmacokinetics (PK) of Risperdal® Consta® [ Time Frame: 57 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male or female patients aged 18 to 65 years old;
  2. Patients must have a DSM-IV diagnosis of schizophrenia or schizoaffective disorder based on the Mini-International Neuropsychiatric Interview (MINI);
  3. Patients must be clinically stable on antipsychotic medications other than risperidone or paliperidone or clozapine for at least 4 weeks prior to screening, based on clinical assessments and a Positive and Negative Syndrome Scale (PANSS) total score less than or equal 70 at screening visit;
  4. Patients with a Body Mass Index in range of 18.0 to 35.0;
  5. Patients with an Informed consent form signed by the patient or legally acceptable representative

Exclusion Criteria:

  1. Patients with a mental disorders other than schizophrenia or schizoaffective disorder, according to the DSM-IV;
  2. Patients who received oral risperidone or paliperidone or clozapine within 14 days prior to screening, or Risperdal® Consta® within 100 days or LY03004 within 80 days prior to screening or paliperidone palmitate within 10 months prior to screening;
  3. Patients with neuroleptic malignant syndrome or physical fatigue associated with dehydration or malnutrition;
  4. Patients who pose a significant risk of a suicide attempt based on history, investigator's judgment or have answered "yes" on the questions 4 or 5 for current or past 30 days on the Baseline/Screening Version of the Columbia Suicide Severity Rating Scale (C-SSRS).
  5. Patients with a history of sensitivity to akathisia and other EPS, especially with previous use of risperidone or paliperidone.
  6. Patients with uncontrolled diabetes mellitus as indicated by a HbA1c level greater than or equal 7%;
  7. Patients with a history of or currently having epilepsy or convulsion disorders;
  8. Patients who have had electroconvulsive therapy within the past 2 months prior to screening;
  9. Patients who used medication known to be an inducer or inhibitor for CYP 2D6 less than 2 weeks prior to screening;
  10. Patients with a history of allergic reaction to risperidone or to the excipients of LY03004;
  11. Patients who have met DSM-IV-TR criteria for substance abuse or dependence with the exception of caffeine or nicotine in the past 6 months prior to screening
  12. Patients with a history of clinically relevant cardiac arrhythmia's, cardiovascular disease, thyrotoxicosis, parkinsonism, or hemorrhagic diathesis;
  13. Patients who are currently taking medications with primarily CNS activities such as antidepressants, mood stablizers or anticonvulsants;
  14. Patients who have participated in a clinical trial of another investigational drug within 30 days prior to screening;
  15. Female patients who are pregnant or are breastfeeding or are of childbearing potential without adequate contraception.
  16. Patients who have any clinically relevant hepatic, renal and cardiac dysfunction, or other medical condition or laboratory abnormality, which in the judgment of the investigator would interfere with the subject's ability to participate in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02186769

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United States, California
Neuropsychiatric Research Center of Orange County
Orange County, California, United States, 92868
United States, Texas
Community Clinical Research Inc
Austin, Texas, United States, 78754
Sponsors and Collaborators
Luye Pharma Group Ltd.
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Responsible Party: Luye Pharma Group Ltd. Identifier: NCT02186769    
Other Study ID Numbers: LY03004/CT-USA-104
First Posted: July 10, 2014    Key Record Dates
Last Update Posted: June 18, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents