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

Phase 2

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Risperidone 4mg; Drug: MP-214 9mg; Drug: MP-214 3mg; Drug: MP-214 6mg

• Registration Number: NCT01626872
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-19
• Study First Submitted QC: 2012-06-20
• Study First Posted: 2012-06-25
• Study Start: 2012-09
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Results First Submitted: 2021-01-11
• Status Verified: 2021-04
• Results First Submitted QC: 2021-04-08
• Last Update Submitted: 2021-04-08
• Results First Posted: 2021-04-12
• Last Update Posted: 2021-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 254

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Risperidone 4mg	Risperidone 4mg	-
MP-214 9mg	MP-214 9mg	-
MP-214 3mg	MP-214 3mg	-
MP-214 6mg	MP-214 6mg	-

Primary Outcome Measures

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