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Pharmacokinetic and Safety Study of LY03004 in Stable Patients With Schizophrenia or Schizoaffective Disorder (LY03004SAD)

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.
 
ClinicalTrials.gov Identifier: NCT02055287
Recruitment Status : Completed
First Posted : February 5, 2014
Last Update Posted : November 10, 2014
Sponsor:
Information provided by (Responsible Party):
Luye Pharma Group Ltd.

Brief Summary:
The purpose of this study is to characterize the pharmacokinetics (PK) of LY03004 following an escalating single intramuscular injection at 12.5, 25, 37.5, or 50 mg; and to evaluate the safety and tolerability and preliminary efficacy of LY03004 following intramuscular injection.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Single Ascending Dose Pharmacokinetic and Safety Study of LY03004 Following Escalating Single Intramuscular Injection in Stable Patients With Schizophrenia or Schizoaffective Disorder
Study Start Date : March 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: LY03004- 12.5
LY03004 dosage strength at 12.5mg
Drug: LY03004
Experimental: LY03004 - 25
LY03004 Dose Strength 25mg
Drug: LY03004
Experimental: LY03004- 37.5
LY03004 Dose Strength 37.5mg
Drug: LY03004
Experimental: LY03004 - 50
LY03004 Dose Strength 50mg
Drug: LY03004



Primary Outcome Measures :
  1. Cmax for the Pharmacokinetics (PK) of LY03004 [ Time Frame: 43 Days ]

Secondary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 43 Days ]
  2. The change of the PANSS score for the Preliminary efficacy of LY03004 [ Time Frame: 43 Days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
Criteria

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 to 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 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 screening form 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 to 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 stabilizers 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 ClinicalTrials.gov identifier (NCT number): NCT02055287


Locations
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United States, California
Neuropsychiatric Research Center of Orange County
Orange, 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.
ClinicalTrials.gov Identifier: NCT02055287    
Other Study ID Numbers: LY03004
First Posted: February 5, 2014    Key Record Dates
Last Update Posted: November 10, 2014
Last Verified: November 2014
Keywords provided by Luye Pharma Group Ltd.:
schizophrenia
schizoaffective disorder
Additional relevant MeSH terms:
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Disease
Schizophrenia
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders