Safety, Pharmacokinetics and Efficacy Study of MP-214 in Patients With Schizophrenia

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety, pharmacokinetics and efficacy of 3 fixed doses of MP-214 orally administered once daily to patients with schizophrenia. MP-214 tablets will be administered to patients starting at an initial dose, followed by up-titration to a fixed dose (low, medium or high) for 14 days.

Official Title
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Phase II Study of MP-214 in Patients With Schizophrenia (Exploratory Study)

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Cariprazine 3 mg
* Drug: Cariprazine 6 mg
* Drug: Cariprazine 12.5 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients meeting DSM-IV-TR criteria for schizophrenia PANSS total score <= 120 during the observation period Patients who have been treated with oral antipsychotics within 4 weeks before informed consent Patients whose consent is obtained from themselves in written form Exclusion Criteria: Patients who have defined as any mental disorder other than Schizophrenia based on the criteria of DSM-IV-TR History of drug or alcohol abuse Concurrent Parkinson's disease History of, or concurrent spastic disorders like epilepsy, cerebrovascular disease, anuresis or adynamic(= paralytic) ileus, malignant syndrome, diabetes, hepatic disorder Patients who exhibit abnormalities on Physical Examination, have abnormal vital signs, ECG, or clinical laboratory values Current cataract during the observation period History of shock or anaphylactoid symptoms to drugs The information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Cariprazine 3 mg<br> <br> * Other names: RGH-188;|
| Experimental: 2<br> | Drug: Cariprazine 6 mg<br> <br> |
| Experimental: 3<br> | Drug: Cariprazine 12.5 mg<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Event and Adverse Drug Reaction |  | Up to 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 14 |  | Pre-dose, 3, 4, 6, 8, 24, 48, 72, 96 and 168 hours post-dose of Day 14. | 
| Time to Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 14 |  | Pre-dose, 3, 4, 6, 8, 24, 48, 72, 96 and 168 hours post-dose of Day 14. | 
| Area Under the Plasma Concentration-Time Curve From Time Zero to Last of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 14 |  | Pre-dose, 3, 4, 6, 8, 24, 48, 72, 96 and 168 hours post-dose of Day 14. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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schizophrenia, antipsychotics, dopamine D3/D2 antagonist