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

Tanabe Pharma Corporation

Status and phase: Completed; Phase 3; Phase 2

Conditions: Schizophrenia

Treatments: Drug: MP-214 9mg; Drug: MP-214 6mg; Drug: MP-214 3mg; Drug: Risperidone 4mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01626872

A002-A5

Details and patient eligibility

About

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

Enrollment: 254 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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254 participants in 4 patient groups

MP-214 3mg

Experimental group

Treatment:

Drug: MP-214 3mg

MP-214 6mg

Experimental group

Treatment:

Drug: MP-214 6mg

MP-214 9mg

Experimental group

Treatment:

Drug: MP-214 9mg

Risperidone 4mg

Active Comparator group

Treatment:

Drug: Risperidone 4mg