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NCT01626872 Clinical Trial

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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01626872
Other study ID # A002-A5
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date September 2012
Est. completion date October 2016

Study information
Verified date April 2021
Source Mitsubishi Tanabe Pharma Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 254
Est. completion date October 2016
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender All
Age group 20 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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).
• 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).
• 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).
• 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).

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Mitsubishi Tanabe Pharma Corporation

Countries where clinical trial is conducted

Japan,  Korea, Republic of,  Taiwan, 

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