Back to resultsLong-Term Study of MP-214 in Patients With Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MP-214 3mg
MP-214 6mg
MP-214 9mg
Risperidone 4mg
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Antipsychotic Agents, Mental Disorder, Psychotropic Drugs, Dopamine Agents, Risperidone, Central Nervous System Agents
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
MP-214 3mg
MP-214 6mg
MP-214 9mg
Risperidone 4mg
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
The Numbers show Subjects with at least one Adverse Event
Secondary Outcome Measures
Full Information
NCT ID
NCT01626872
First Posted
June 19, 2012
Last Updated
April 8, 2021
Sponsor
Mitsubishi Tanabe Pharma Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01626872
Brief Title
Long-Term Study of MP-214 in Patients With Schizophrenia
Official Title
Long-Term Extension Study of MP-214 in Patients With Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsubishi Tanabe Pharma Corporation
4. Oversight
5. Study Description
Brief Summary
The objective of this study is to evaluate the long-term safety, tolerability, and efficacy of MP-214 in patients with schizophrenia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Antipsychotic Agents, Mental Disorder, Psychotropic Drugs, Dopamine Agents, Risperidone, Central Nervous System Agents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
254 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MP-214 3mg
Arm Type
Experimental
Arm Title
MP-214 6mg
Arm Type
Experimental
Arm Title
MP-214 9mg
Arm Type
Experimental
Arm Title
Risperidone 4mg
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
MP-214 3mg
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
MP-214 6mg
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
MP-214 9mg
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Risperidone 4mg
Intervention Description
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).
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Description
The Numbers show Subjects with at least one Adverse Event
Time Frame
Up to 60 weeks (Treatment Period (48 weeks) and Follow-up Period (12 weeks))
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
City
Sapporo
State/Province
Hokkaido
Country
Japan
City
Seoul
Country
Korea, Republic of
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Long-Term Study of MP-214 in Patients With Schizophrenia
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