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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 chronic phase or elderly schizophrenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MP-214 1.5-9mg | Experimental |
| |
| Risperidone 2-12mg | Active Comparator |
|
| 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 or 6mg) of MP-214 for four weeks, then flexible dose (1.5-9mg) 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:
Written informed consent obtained from the patient before the initiation of any study-specific procedures
Patients diagnosed with schizophrenia according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia
Patients who meet at least one of the following:
Patients with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ECG)
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 |
|---|---|---|---|---|---|---|
| Aizu-Wakamatsu | Fukushima | Japan |
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| ID | Title | Description |
|---|---|---|
| FG000 | MP-214 1.5-9mg | Patients who meet eligibility criteria will be administered a once daily oral fixed dose (3mg or 6mg) of MP-214 for four weeks, then flexible dose (1.5-9mg) of MP-214 |
| FG001 | Risperidone 2-12mg | Patients who meet eligibility criteria will be administered a once daily oral fixed dose (4mg) of risperidone for two weeks, then flexible dose (2-12mg) of risperidone |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MP-214 1.5-9mg | Patients who meet eligibility criteria will be administered a once daily oral fixed dose (3mg or 6mg) of MP-214 for four weeks, then flexible dose (1.5-9mg) of MP-214 |
| BG001 | Risperidone 2-12mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| 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 1.5-9mg | Patients who meet eligibility criteria will be administered a once daily oral fixed dose (3mg or 6mg) of MP-214 for four weeks, then flexible dose (1.5-9mg) of MP-214 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholangitis | Hepatobiliary disorders | MedDRA 17.1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperprolactinaemia | Endocrine disorders | MedDRA 17.1 |
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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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| Risperidone | Drug | Patients who meet eligibility criteria will be administered a once daily oral fixed dose (4mg) of risperidone for two weeks, then flexible dose (2-12mg) of risperidone |
|
| Withdrawal by Subject |
|
Patients who meet eligibility criteria will be administered a once daily oral fixed dose (4mg) of risperidone for two weeks, then flexible dose (2-12mg) of risperidone
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 13 |
| 83 |
| 72 |
| 83 |
| EG001 | Risperidone 2-12mg | Patients who meet eligibility criteria will be administered a once daily oral fixed dose (4mg) of risperidone for two weeks, then flexible dose (2-12mg) of risperidone | 4 | 42 | 39 | 42 |
| Diverticulitis | Infections and infestations | MedDRA 17.1 |
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| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 17.1 |
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| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 17.1 |
|
| Brain stem haemorrhage | Nervous system disorders | MedDRA 17.1 |
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| Schizophrenia | Psychiatric disorders | MedDRA 17.1 |
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| Constipation | Gastrointestinal disorders | MedDRA 17.1 |
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| Dental caries | Gastrointestinal disorders | MedDRA 17.1 |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 |
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| Nausea | Gastrointestinal disorders | MedDRA 17.1 |
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| Vomiting | Gastrointestinal disorders | MedDRA 17.1 |
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| Malaise | General disorders | MedDRA 17.1 |
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| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 17.1 |
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| Influenza | Infections and infestations | MedDRA 17.1 |
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| Nasopharyngitis | Infections and infestations | MedDRA 17.1 |
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| Blood creatine phosphokinase increased | Investigations | MedDRA 17.1 |
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| Blood prolactin increased | Investigations | MedDRA 17.1 |
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| Blood urine present | Investigations | MedDRA 17.1 |
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| Weight increased | Investigations | MedDRA 17.1 |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 |
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| Akathisia | Nervous system disorders | MedDRA 17.1 |
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| Headache | Nervous system disorders | MedDRA 17.1 |
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| Parkinsonism | Nervous system disorders | MedDRA 17.1 |
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| Somnolence | Nervous system disorders | MedDRA 17.1 |
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| Insomnia | Nervous system disorders | MedDRA 17.1 |
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| Schizophrenia | Nervous system disorders | MedDRA 17.1 |
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| Suicidal ideation | Nervous system disorders | MedDRA 17.1 |
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| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA 17.1 |
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| Hypertension | Vascular disorders | MedDRA 17.1 |
|
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