NCT01626872CompletedPhase 2
Long-Term Extension Study of MP-214 in Patients With Schizophrenia
Tanabe Pharma Corporation3 sites in 3 countries254 target enrollmentStarted: September 1, 2012Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Tanabe Pharma Corporation
- Enrollment
- 254
- Locations
- 3
- Primary Endpoint
- Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Study Overview
Brief Summary
The objective of this study is to evaluate the long-term safety, tolerability, and efficacy of MP-214 in patients with schizophrenia.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
MP-214 3mg
Experimental
Intervention: MP-214 3mg (Drug)
MP-214 6mg
Experimental
Intervention: MP-214 6mg (Drug)
MP-214 9mg
Experimental
Intervention: MP-214 9mg (Drug)
Risperidone 4mg
Active Comparator
Intervention: Risperidone 4mg (Drug)
Outcomes
Primary Outcomes
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time Frame: Up to 60 weeks (Treatment Period (48 weeks) and Follow-up Period (12 weeks))
The Numbers show Subjects with at least one Adverse Event
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (3)
Loading locations...
Similar Trials
Completed
Phase 2
A Long-Term Study of MP-214 in Patients With Receiving Multiple Drugs SchizophreniaSchizophreniaNCT01626885Tanabe Pharma Corporation42
Completed
Phase 2
A Long-Term Study of MP-214 in Patients With Chronic Phase or Elderly SchizophreniaSchizophreniaNCT01625897Tanabe Pharma Corporation125
Completed
Phase 3
Long-Term Extension Study of Lu AA21004 in Participants With Major Depressive DisorderMajor Depressive DisorderNCT01395147Takeda119
Completed
Phase 2
A Long-term Extension Study of E2007 in Patients With Refractory Partial Seizures Uncontrolled With Other Anti-Epileptic Drugs (AEDs)Refractory Partial SeizuresNCT00903786Eisai Co., Ltd.21
Terminated
Phase 3
An Extension Study to Evaluate Casimersen or Golodirsen in Patients With Duchenne Muscular DystrophyDuchenne Muscular DystrophyNCT03532542Sarepta Therapeutics, Inc.171