Schizophrenia
Conditions
Keywords
Schizophrenia, Antipsychotic Agents, Mental Disorder, Psychotropic Drugs, Dopamine Agents, Risperidone, Central Nervous System Agents
Brief summary
The objective of this study is to evaluate the long-term safety, tolerability, and efficacy of MP-214 in patients with schizophrenia.
Interventions
DRUGRisperidone 4mg
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).
DRUGMP-214 3mg
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).
DRUGMP-214 6mg
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).
DRUGMP-214 9mg
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).
Sponsors
Tanabe Pharma Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Up to 60 weeks (Treatment Period (48 weeks) and Follow-up Period (12 weeks)) | The Numbers show Subjects with at least one Adverse Event |
Countries
Japan, South Korea, Taiwan
Participant flow
Pre-assignment details
Six patients who did not receive MP-214 during the open-label phase were excluded from the analysis population.
Participants by arm
| Arm | Count |
|---|---|
| MP-214 3mg | 81 |
| MP-214 6mg | 109 |
| MP-214 9mg | 58 |
| Total | 248 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event (including Death) | 20 | 28 | 8 |
| Overall Study | Physician Decision | 13 | 9 | 6 |
| Overall Study | Protocol Violation (including Pregnancy) | 0 | 2 | 2 |
| Overall Study | Withdrawal by Subject | 19 | 27 | 8 |
Baseline characteristics
| Characteristic | MP-214 3mg | MP-214 6mg | MP-214 9mg | Total |
|---|---|---|---|---|
| Age, Continuous | 38.0 years STANDARD_DEVIATION 11.1 | 40.8 years STANDARD_DEVIATION 11.3 | 42.5 years STANDARD_DEVIATION 8.9 | 40.3 years STANDARD_DEVIATION 10.8 |
| Sex: Female, Male Female | 40 Participants | 56 Participants | 20 Participants | 116 Participants |
| Sex: Female, Male Male | 41 Participants | 53 Participants | 38 Participants | 132 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 55 / 81 | 72 / 109 | 42 / 58 |
| serious Total, serious adverse events | 14 / 81 | 33 / 109 | 14 / 58 |
Outcome results
Primary
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
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))
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MP-214 3mg | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 67 Participants |
| MP-214 6mg | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 92 Participants |
| MP-214 9mg | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 50 Participants |