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

Primary Purpose

Schizophrenia

Status

Completed

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

Cariprazine 3 mg

Cariprazine 6 mg

Cariprazine 12.5 mg

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, antipsychotics, dopamine D3/D2 antagonist

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hoyu Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Event and Adverse Drug Reaction

Secondary Outcome Measures

Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 14

Time to Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at 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

Full Information

NCT ID

NCT00862992

First Posted

March 15, 2009

Last Updated

April 8, 2021

Sponsor

Mitsubishi Tanabe Pharma Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00862992

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

April 2008 (undefined)

Primary Completion Date

September 2009 (Actual)

Study Completion Date

September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mitsubishi Tanabe Pharma Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia

Keywords

schizophrenia, antipsychotics, dopamine D3/D2 antagonist

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Cariprazine 3 mg

Other Intervention Name(s)

Cariprazine(INN), RGH-188

Intervention Type

Drug

Intervention Name(s)

Cariprazine 6 mg

Intervention Type

Drug

Intervention Name(s)

Cariprazine 12.5 mg

Primary Outcome Measure Information:

Title

Number of Participants With Adverse Event and Adverse Drug Reaction

Time Frame

Up to 7 weeks

Secondary Outcome Measure Information:

Title

Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 14

Time Frame

Pre-dose, 3, 4, 6, 8, 24, 48, 72, 96 and 168 hours post-dose of Day 14.

Title

Time to Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 14

Time Frame

Pre-dose, 3, 4, 6, 8, 24, 48, 72, 96 and 168 hours post-dose of Day 14.

Title

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

Time Frame

Pre-dose, 3, 4, 6, 8, 24, 48, 72, 96 and 168 hours post-dose of Day 14.

Other Pre-specified Outcome Measures:

Title

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 14 (Last Observation Carried Forward; LOCF)

Description

PANSS score is a 30-item rating scale to assess both the positive and negative symptom syndromes of patients with schizophrenia. Each item is scored on a 7-point scale, from 1 (absent) to 7 (extreme). The PANSS total score of the 30 PANSS items ranges from 30 to 210. High scores indicate greater severity of symptoms.

Time Frame

at baseline, and on Day 14 or a last observation carried forward (LOCF)

Title

Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score at Day 14 (Last Observation Carried Forward; LOCF)

Description

CGI-S is a 7-point scale to assess the global severity of the participant's illness. CGI-S scores range from 1 (normal, not ill at all) to 7 (extremely ill).

Time Frame

at baseline, and on Day 14 or a last observation carried forward (LOCF)

Title

The Clinical Global Impression-Improvement (CGI-I) Score at Day 14 (Last Observation Carried Forward; LOCF)

Description

CGI-I is a 7-point scale to assess the global improvement of the participant's illness relative to baseline. CGI-I scores range from 1 (very much improved) to 7 (very much worse).

Time Frame

on Day 14 or a last observation carried forward (LOCF)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Teruhiko Higuchi, President

Organizational Affiliation

National Center of Neurology and Psychiatry

Official's Role

Study Chair

Facility Information:

Facility Name

Hoyu Hospital

City

Kure-City

State/Province

Hiroshima-ken

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

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

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