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The purpose of this study is to assess the safety, pharmacokinetics and efficacy of 3 fixed doses of MP-214 orally administered once daily to patients with schizophrenia. MP-214 tablets will be administered to patients starting at an initial dose, followed by up-titration to a fixed dose (low, medium or high) for 14 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cariprazine 3 mg | Drug |
|
| |
| Cariprazine 6 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Event and Adverse Drug Reaction | Up to 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 14 | Pre-dose, 3, 4, 6, 8, 24, 48, 72, 96 and 168 hours post-dose of Day 14. | |
| Time to Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 14 (Last Observation Carried Forward; LOCF) | PANSS score is a 30-item rating scale to assess both the positive and negative symptom syndromes of patients with schizophrenia. Each item is scored on a 7-point scale, from 1 (absent) to 7 (extreme). The PANSS total score of the 30 PANSS items ranges from 30 to 210. High scores indicate greater severity of symptoms. |
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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| Name | Affiliation | Role |
|---|---|---|
| Teruhiko Higuchi, President | National Center of Neurology and Psychiatry | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hoyu Hospital | Kure | Hiroshima | Japan |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cariprazine 3 mg | |
| FG001 | Cariprazine 6 mg | |
| FG002 | Cariprazine 12.5 mg |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cariprazine 3 mg | |
| BG001 | Cariprazine 6 mg | |
| BG002 | Cariprazine 12.5 mg |
| 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 Event and Adverse Drug Reaction | Posted | Count of Participants | Participants | Up to 7 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 | Cariprazine 3 mg |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 12.0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinus bradycardia | Cardiac disorders | MedDRA 12.0 |
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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 |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C533287 | cariprazine |
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| Drug |
|
| Cariprazine 12.5 mg | Drug |
|
| Pre-dose, 3, 4, 6, 8, 24, 48, 72, 96 and 168 hours post-dose of Day 14. |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Last of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 14 | Pre-dose, 3, 4, 6, 8, 24, 48, 72, 96 and 168 hours post-dose of Day 14. |
| at baseline, and on Day 14 or a last observation carried forward (LOCF) |
| Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score at Day 14 (Last Observation Carried Forward; LOCF) | CGI-S is a 7-point scale to assess the global severity of the participant's illness. CGI-S scores range from 1 (normal, not ill at all) to 7 (extremely ill). | at baseline, and on Day 14 or a last observation carried forward (LOCF) |
| The Clinical Global Impression-Improvement (CGI-I) Score at Day 14 (Last Observation Carried Forward; LOCF) | CGI-I is a 7-point scale to assess the global improvement of the participant's illness relative to baseline. CGI-I scores range from 1 (very much improved) to 7 (very much worse). | on Day 14 or a last observation carried forward (LOCF) |
| Withdrawal by Subject |
|
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Secondary | Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 14 | Of the 34 participants, 7 subjects who prematurely discontinued during the titration period, 1 subject used prohibited concomitant medication and 1 subject did not take the test product on Day 12 of the fixed-dose period were excluded from the pharmacokinetic analysis. | Posted | Mean | Standard Deviation | ng/mL | Pre-dose, 3, 4, 6, 8, 24, 48, 72, 96 and 168 hours post-dose of Day 14. |
|
|
|
| Secondary | Time to Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 14 | Of the 34 participants, 7 subjects who prematurely discontinued during the titration period, 1 subject used prohibited concomitant medication and 1 subject did not take the test product on Day 12 of the fixed-dose period were excluded from the pharmacokinetic analysis. | Posted | Mean | Standard Deviation | hour | Pre-dose, 3, 4, 6, 8, 24, 48, 72, 96 and 168 hours post-dose of Day 14. |
|
|
|
| Secondary | Area Under the Plasma Concentration-Time Curve From Time Zero to Last of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 14 | Of the 34 participants, 7 subjects who prematurely discontinued during the titration period, 1 subject used prohibited concomitant medication and 1 subject did not take the test product on Day 12 of the fixed-dose period were excluded from the pharmacokinetic analysis. | Posted | Mean | Standard Deviation | ng*hr/mL | Pre-dose, 3, 4, 6, 8, 24, 48, 72, 96 and 168 hours post-dose of Day 14. |
|
|
|
| Other Pre-specified | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 14 (Last Observation Carried Forward; LOCF) | PANSS score is a 30-item rating scale to assess both the positive and negative symptom syndromes of patients with schizophrenia. Each item is scored on a 7-point scale, from 1 (absent) to 7 (extreme). The PANSS total score of the 30 PANSS items ranges from 30 to 210. High scores indicate greater severity of symptoms. | Posted | Mean | Standard Deviation | units on a scale | at baseline, and on Day 14 or a last observation carried forward (LOCF) |
|
|
|
| Other Pre-specified | Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score at Day 14 (Last Observation Carried Forward; LOCF) | CGI-S is a 7-point scale to assess the global severity of the participant's illness. CGI-S scores range from 1 (normal, not ill at all) to 7 (extremely ill). | Posted | Mean | Standard Deviation | units on a scale | at baseline, and on Day 14 or a last observation carried forward (LOCF) |
|
|
|
| Other Pre-specified | The Clinical Global Impression-Improvement (CGI-I) Score at Day 14 (Last Observation Carried Forward; LOCF) | CGI-I is a 7-point scale to assess the global improvement of the participant's illness relative to baseline. CGI-I scores range from 1 (very much improved) to 7 (very much worse). | Posted | Mean | Standard Deviation | units on a scale | on Day 14 or a last observation carried forward (LOCF) |
|
|
|
| 3 |
| 12 |
| 9 |
| 12 |
| EG001 | Cariprazine 6 mg | 1 | 10 | 9 | 10 |
| EG002 | Cariprazine 12.5 mg | 2 | 12 | 11 | 12 |
| Blood creatine phosphokinase increased | Investigations | MedDRA 12.0 |
|
| Neuroleptic malignant syndrome | Nervous system disorders | MedDRA 12.0 |
|
| Schizophrenia | Psychiatric disorders | MedDRA 12.0 |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 12.0 |
|
| Conjunctivitis | Eye disorders | MedDRA 12.0 |
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| Dry eye | Eye disorders | MedDRA 12.0 |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 12.0 |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 12.0 |
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| Cheilitis | Gastrointestinal disorders | MedDRA 12.0 |
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| Constipation | Gastrointestinal disorders | MedDRA 12.0 |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 |
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| Enterocolitis | Gastrointestinal disorders | MedDRA 12.0 |
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| Gastritis | Gastrointestinal disorders | MedDRA 12.0 |
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| Inguinal hernia | Gastrointestinal disorders | MedDRA 12.0 |
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| Lip dry | Gastrointestinal disorders | MedDRA 12.0 |
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| Nausea | Gastrointestinal disorders | MedDRA 12.0 |
|
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA 12.0 |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 12.0 |
|
| Toothache | Gastrointestinal disorders | MedDRA 12.0 |
|
| Feeling abnormal | General disorders | MedDRA 12.0 |
|
| Malaise | General disorders | MedDRA 12.0 |
|
| Pyrexia | General disorders | MedDRA 12.0 |
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| Thirst | General disorders | MedDRA 12.0 |
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| Nasopharyngitis | Infections and infestations | MedDRA 12.0 |
|
| Urinary tract infection | Infections and infestations | MedDRA 12.0 |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 12.0 |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 12.0 |
|
| Nail injury | Injury, poisoning and procedural complications | MedDRA 12.0 |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 12.0 |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 12.0 |
|
| Alanine aminotransferase increased | Investigations | MedDRA 12.0 |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 12.0 |
|
| Blood bilirubin increased | Investigations | MedDRA 12.0 |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 12.0 |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 12.0 |
|
| Blood potassium increased | Investigations | MedDRA 12.0 |
|
| Blood pressure decreased | Investigations | MedDRA 12.0 |
|
| Blood pressure increased | Investigations | MedDRA 12.0 |
|
| Blood prolactin increased | Investigations | MedDRA 12.0 |
|
| Blood triglycerides increased | Investigations | MedDRA 12.0 |
|
| Blood uric acid increased | Investigations | MedDRA 12.0 |
|
| Blood urine present | Investigations | MedDRA 12.0 |
|
| Glucose urine present | Investigations | MedDRA 12.0 |
|
| Hepatic enzyme increased | Investigations | MedDRA 12.0 |
|
| White blood cell count decreased | Investigations | MedDRA 12.0 |
|
| White blood cell count increased | Investigations | MedDRA 12.0 |
|
| Polydipsia | Metabolism and nutrition disorders | MedDRA 12.0 |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 |
|
| Akathisia | Nervous system disorders | MedDRA 12.0 |
|
| Dysarthria | Nervous system disorders | MedDRA 12.0 |
|
| Headache | Nervous system disorders | MedDRA 12.0 |
|
| Hyperaesthesia | Nervous system disorders | MedDRA 12.0 |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 12.0 |
|
| Parkinsonism | Nervous system disorders | MedDRA 12.0 |
|
| Sleep paralysis | Nervous system disorders | MedDRA 12.0 |
|
| Somnolence | Nervous system disorders | MedDRA 12.0 |
|
| Tremor | Nervous system disorders | MedDRA 12.0 |
|
| Insomnia | Psychiatric disorders | MedDRA 12.0 |
|
| Restlessness | Psychiatric disorders | MedDRA 12.0 |
|
| Dysuria | Renal and urinary disorders | MedDRA 12.0 |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 12.0 |
|
| Urinary retention | Renal and urinary disorders | MedDRA 12.0 |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 12.0 |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 12.0 |
|
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA 12.0 |
|
| Poor personal hygiene | Social circumstances | MedDRA 12.0 |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 12.0 |
|
| Hyperthyroidism | Endocrine disorders | MedDRA 12.0 |
|
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|
| M6 (didesmethyl cariprazine) |
|
|
| M6 (didesmethyl cariprazine) |
|
|
| M6 (didesmethyl cariprazine) |
|