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The objective of this study is to evaluate the long-term safety, tolerability, and efficacy of MP-214 in patients with receiving multiple drugs schizophrenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MP-214 1.5-9 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MP-214 | Drug | Patients who meet eligibility criteria will be administered a once daily oral fixed dose (3mg) of MP-214 for four weeks, then flexible dose (1.5-9 mg) of MP-214 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Up to 60 weeks |
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Inclusion Criteria:
Exclusion Criteria:
The information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kurayoshi | Tottori | Japan |
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| ID | Title | Description |
|---|---|---|
| FG000 | MP-214 1.5-9 mg | MP-214: Patients who meet eligibility criteria will be administered a once daily oral fixed dose (3mg) of MP-214 for four weeks, then flexible dose (1.5-9 mg) of MP-214 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MP-214 1.5-9 mg | MP-214: Patients who meet eligibility criteria will be administered a once daily oral fixed dose (3mg) of MP-214 for four weeks, then flexible dose (1.5-9 mg) of MP-214 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Posted | Count of Participants | Participants | Up to 60 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MP-214 1.5-9 mg | MP-214: Patients who meet eligibility criteria will be administered a once daily oral fixed dose (3mg) of MP-214 for four weeks, then flexible dose (1.5-9 mg) of MP-214 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 17.0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 17.0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials, Information Desk | Tanabe Pharma Corporation | cti-inq-ml.JP@ml.tanabe-pharma.com |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| 2 |
| 42 |
| 37 |
| 42 |
| Schizophrenia | Psychiatric disorders | MedDRA 17.0 |
|
| Vomiting | Gastrointestinal disorders | MedDRA 17.0 |
|
| Nasopharyngitis | Infections and infestations | MedDRA 17.0 |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 17.0 |
|
| Alanine aminotransferase increased | Investigations | MedDRA 17.0 |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 17.0 |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 17.0 |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 17.0 |
|
| Weight increased | Investigations | MedDRA 17.0 |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 |
|
| Akathisia | Nervous system disorders | MedDRA 17.0 |
|
| Dizziness | Nervous system disorders | MedDRA 17.0 |
|
| Extrapyramidal disorder | Nervous system disorders | MedDRA 17.0 |
|
| Headache | Nervous system disorders | MedDRA 17.0 |
|
| Somnolence | Nervous system disorders | MedDRA 17.0 |
|
| Anxiety | Psychiatric disorders | MedDRA 17.0 |
|
| Initial insomnia | Psychiatric disorders | MedDRA 17.0 |
|
| Insomnia | Psychiatric disorders | MedDRA 17.0 |
|
| Irritability | Psychiatric disorders | MedDRA 17.0 |
|
| Schizophrenia | Psychiatric disorders | MedDRA 17.0 |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 |
|
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