Overview

This trial is active, not recruiting.

Condition schizophrenia
Treatments mp-214 low dose, mp-214 middle dose, mp-214 high dose, risperidone
Phase phase 2/phase 3
Sponsor Mitsubishi Tanabe Pharma Corporation
Start date June 2012
End date July 2016
Trial size 254 participants
Trial identifier NCT01626872, A002-A5

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
mp-214 low dose
Participants continue in the same arm they were on in core trial A002-A4 (except placebo arm starts low or middle dose of MP-214) and will be re-randomized after Week 6 to low dose or middle dose of MP-214
(Experimental)
mp-214 middle dose
Participants continue in the same arm they were on in core trial A002-A4 (except placebo arm starts low or middle dose of MP-214) and will be re-randomized after Week 6 to low dose or middle dose of MP-214
(Experimental)
mp-214 high dose
Participants continue in the same arm they were on in core trial A002-A4 (except placebo arm starts low or middle dose of MP-214) and will be re-randomized after Week 6 to low dose or middle dose of MP-214
(Active Comparator)
risperidone
Participants continue in the same arm they were on in core trial A002-A4 (except placebo arm starts low or middle dose of MP-214) and will be re-randomized after Week 6 to low dose or middle dose of MP-214

Primary Outcomes

Measure
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
time frame: 60 weeks

Eligibility Criteria

Male or female participants from 20 years up to 64 years old.

Inclusion Criteria: - Written informed consent obtained from the patient before the completion of Study A002-A4 - Patients who have completed the A002-A4 study Exclusion Criteria: - Patients who are experiencing ongoing, uncontrolled, clinically significant adverse events (AEs), as judged by the investigator (or subinvestigator)

Additional Information

Official title Long-Term Extension Study of MP-214 in Patients With Schizophrenia
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Mitsubishi Tanabe Pharma Corporation.