Long-Term Study of MP-214 in Patients With Schizophrenia

April 8, 2021 updated by: Mitsubishi Tanabe Pharma Corporation

Long-Term Extension Study of MP-214 in Patients With Schizophrenia

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

254

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

The information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MP-214 3mg
Drug: MP-214 3mg
In the double-blind period (before Week 6), participants continue in the same arm they were on in core trial A002-A4 (except placebo arm starts 3mg or 6mg of MP-214). In the open-label period (after Week 6), patients will be rerandomized to 3mg or 6mg of MP-214. After the fourth week of the open-label treatment period, they will be received MP-214 at flexible doses (3mg or 6mg or 9mg).
Experimental: MP-214 6mg
Drug: MP-214 6mg
In the double-blind period (before Week 6), participants continue in the same arm they were on in core trial A002-A4 (except placebo arm starts 3mg or 6mg of MP-214). In the open-label period (after Week 6), patients will be rerandomized to 3mg or 6mg of MP-214. After the fourth week of the open-label treatment period, they will be received MP-214 at flexible doses (3mg or 6mg or 9mg).
Experimental: MP-214 9mg
Drug: MP-214 9mg
In the double-blind period (before Week 6), participants continue in the same arm they were on in core trial A002-A4 (except placebo arm starts 3mg or 6mg of MP-214). In the open-label period (after Week 6), patients will be rerandomized to 3mg or 6mg of MP-214. After the fourth week of the open-label treatment period, they will be received MP-214 at flexible doses (3mg or 6mg or 9mg).
Active Comparator: Risperidone 4mg
Drug: Risperidone 4mg
In the double-blind period (before Week 6), participants continue in the same arm they were on in core trial A002-A4. In the open-label period (after Week 6), patients will be rerandomized to 3mg or 6mg of MP-214. After the fourth week of the open-label treatment period, they will be received MP-214 at flexible doses (3mg or 6mg or 9mg).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time Frame: Up to 60 weeks (Treatment Period (48 weeks) and Follow-up Period (12 weeks))
The Numbers show Subjects with at least one Adverse Event
Up to 60 weeks (Treatment Period (48 weeks) and Follow-up Period (12 weeks))

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mitsubishi Tanabe Pharma Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

June 19, 2012

First Submitted That Met QC Criteria

June 20, 2012

First Posted (Estimate)

June 25, 2012

Study Record Updates

Last Update Posted (Actual)

April 12, 2021

Last Update Submitted That Met QC Criteria

April 8, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A002-A5

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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