Phase 3
N=248
Long-Term Study of MP-214 in Patients With Schizophrenia
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT01626872 ↗Enrolled (actual)
248
Serious AEs
24.6%
Results posted
Apr 2021
Primary outcome: Primary: Number of Participants With Adverse Events as a Measure of Safety and Tolerability — 67; 92; 50 Participants
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)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Tanabe Pharma Corporation
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events as a Measure of Safety and Tolerability |
67; 92; 50 | — |
Summary
The objective of this study is to evaluate the long-term safety, tolerability, and efficacy of MP-214 in patients with schizophrenia.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01626872). 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.