A Pharmacokinetic Study of MP-214 in Patients With Schizophrenia

NCT01626859 | Completed Phase 2 Results

• 1 other identifier: A002-A11
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the pharmacokinetics, safety and efficacy of MP-214 in patients with schizophrenia.

Conditions

Schizophrenia

Keywords

Schizophrenia; Antipsychotic Agents; Mental Disorder; Psychotropic Drugs; Dopamine Agents; Central Nervous System Agents

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Adverse Events as a Measure of Safety and Tolerability

  Up to 24 weeks

• Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 84

  On Day 84 samples were taken pre-dose and 3, 4, 6 and 8 hours post-dose.

• Time to Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 84

  On Day 84 samples were taken pre-dose and 3, 4, 6 and 8 hours post-dose.

• Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 84

  On Day 84 samples were taken pre-dose and 3, 4, 6 and 8 hours post-dose.

Study Arms (3)

MP-214 3mg

EXPERIMENTAL

Drug: MP-214 3mg

MP-214 6mg

EXPERIMENTAL

Drug: MP-214 6mg

MP-214 9mg

EXPERIMENTAL

Drug: MP-214 9mg

Interventions

MP-214 3mg DRUG

Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for twelve weeks.

MP-214 3mg

MP-214 6mg DRUG

Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for twelve weeks.

MP-214 6mg

MP-214 9mg DRUG

Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for twelve weeks.

MP-214 9mg

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Written informed consent obtained from the patient before the initiation of any study-specific procedures
• Patients diagnosed with schizophrenia according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia
• Patients with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ECG)

You may not qualify if:

• Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder
• The information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (1)

Unknown Facility

Sakai, Osaka, Japan

Location

MeSH Terms

Conditions

Schizophrenia; Mental Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders

Results Point of Contact

• Title: Clinical Trials, Information Desk
• Organization: Tanabe Pharma Corporation

cti-inq-ml.JP@ml.tanabe-pharma.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2012
• First Posted: June 25, 2012
• Study Start: May 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: January 5, 2026
• Results First Posted: April 12, 2021

Record last verified: 2025-12

Locations

JP (1)