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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 schizophrenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MP-214 3mg | Experimental |
| |
| MP-214 6mg | Experimental |
| |
| MP-214 9mg | Experimental |
| |
| Risperidone 4mg | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MP-214 3mg | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | The Numbers show Subjects with at least one Adverse Event | Up to 60 weeks (Treatment Period (48 weeks) and Follow-up Period (12 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 |
|---|---|---|---|---|---|---|
| Sapporo | Hokkaido | Japan | ||||
Six patients who did not receive MP-214 during the open-label phase were excluded from the analysis population.
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| ID | Title | Description |
|---|---|---|
| FG000 | MP-214 3mg | |
| FG001 | MP-214 6mg | |
| FG002 | MP-214 9mg |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MP-214 3mg | |
| BG001 | MP-214 6mg | |
| BG002 | MP-214 9mg |
| 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 | The Numbers show Subjects with at least one Adverse Event | Posted | Count of Participants | Participants | Up to 60 weeks (Treatment Period (48 weeks) and Follow-up Period (12 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 3mg |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 18.1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 18.1 |
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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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| ID | Term |
|---|---|
| D018967 | Risperidone |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| MP-214 6mg | Drug | 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). |
|
| MP-214 9mg | Drug | 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). |
|
| Risperidone 4mg | Drug | 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). |
|
| Seoul |
| South Korea |
| Taipei | Taiwan |
| Adverse Event (including Death) |
|
| Protocol Violation (including Pregnancy) |
|
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| 14 |
| 81 |
| 55 |
| 81 |
| EG001 | MP-214 6mg | 33 | 109 | 72 | 109 |
| EG002 | MP-214 9mg | 14 | 58 | 42 | 58 |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 18.1 |
|
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA 18.1 |
|
| Scar | Injury, poisoning and procedural complications | MedDRA 18.1 |
|
| Skin scar contracture | Injury, poisoning and procedural complications | MedDRA 18.1 |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 |
|
| Completed suicide | Psychiatric disorders | MedDRA 18.1 |
|
| Insomnia | Psychiatric disorders | MedDRA 18.1 |
|
| Mania | Psychiatric disorders | MedDRA 18.1 |
|
| Psychiatric symptom | Psychiatric disorders | MedDRA 18.1 |
|
| Schizophrenia | Psychiatric disorders | MedDRA 18.1 |
|
| Schizophrenia, paranoid type | Psychiatric disorders | MedDRA 18.1 |
|
| Somatoform disorder | Psychiatric disorders | MedDRA 18.1 |
|
| Suicidal ideation | Psychiatric disorders | MedDRA 18.1 |
|
| Suicide attempt | Psychiatric disorders | MedDRA 18.1 |
|
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA 18.1 |
|
| Abortion induced | Surgical and medical procedures | MedDRA 18.1 |
|
| Constipation | Gastrointestinal disorders | MedDRA 18.1 |
|
| Dental caries | Gastrointestinal disorders | MedDRA 18.1 |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 |
|
| Nausea | Gastrointestinal disorders | MedDRA 18.1 |
|
| Vomiting | Gastrointestinal disorders | MedDRA 18.1 |
|
| Nasopharyngitis | Infections and infestations | MedDRA 18.1 |
|
| Tinea pedis | Infections and infestations | MedDRA 18.1 |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 18.1 |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 18.1 |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 18.1 |
|
| Weight increased | Investigations | MedDRA 18.1 |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 |
|
| Akathisia | Nervous system disorders | MedDRA 18.1 |
|
| Dizziness | Nervous system disorders | MedDRA 18.1 |
|
| Extrapyramidal disorder | Nervous system disorders | MedDRA 18.1 |
|
| Headache | Nervous system disorders | MedDRA 18.1 |
|
| Somnolence | Nervous system disorders | MedDRA 18.1 |
|
| Tremor | Nervous system disorders | MedDRA 18.1 |
|
| Anxiety | Psychiatric disorders | MedDRA 18.1 |
|
| Insomnia | Psychiatric disorders | MedDRA 18.1 |
|
| Restlessness | Psychiatric disorders | MedDRA 18.1 |
|
| Schizophrenia | Psychiatric disorders | MedDRA 18.1 |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 18.1 |
|
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA 18.1 |
|
| Hypertension | Vascular disorders | MedDRA 18.1 |
|
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