Phase 3 N=508 Randomized Quadruple-blind Treatment

Safety and Efficacy of MP-214 in Patients With Schizophrenia

Schizophrenia

Bottom Line

View on ClinicalTrials.gov: NCT01625000 ↗

Enrolled (actual)

508

Serious AEs

9.5%

Results posted

Apr 2021

Primary outcome: Primary: Change in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 — -10.4; -13.8; -14.0; -20.2 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: MP-214 3mg (Drug); MP-214 6mg (Drug); MP-214 9mg (Drug); Risperidone 4mg (Drug); Placebo (Drug)
Age: Adult · 20+ yrs
Sex: All
Sponsor: Tanabe Pharma Corporation
Primary completion: Aug 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6	-10.4; -13.8; -14.0; -20.2; -9.5	—
SECONDARY Change in the Clinical Global Impression-Severity (CGI-S) Score at Week 6	-0.7; -0.8; -0.7; -1.2; -0.6	—

Summary

The objective of this study is to evaluate the efficacy, safety, and tolerability of MP-214 relative to placebo in patients with acute exacerbation of schizophrenia.

Eligibility Criteria

Inclusion Criteria

Written informed consent obtained from the patient before the initiation of any study-specific procedures
Patients diagnosed with schizophrenia according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia
Patients with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ECG)

Exclusion Criteria

Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01625000). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.