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The objective of this study is to evaluate the pharmacokinetics, safety 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MP-214 3mg | Drug | Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for twelve weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Up to 24 weeks | |
| Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 84 | On Day 84 samples were taken pre-dose and 3, 4, 6 and 8 hours post-dose. | |
| Time to Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 84 | On Day 84 samples were taken pre-dose and 3, 4, 6 and 8 hours post-dose. | |
| Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 84 | On Day 84 samples were taken pre-dose and 3, 4, 6 and 8 hours post-dose. |
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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 |
|---|---|---|---|---|---|---|
| Sakai | Osaka | Japan |
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| ID | Title | Description |
|---|---|---|
| FG000 | MP-214 3mg | MP-214 3mg: Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for twelve weeks. |
| FG001 | MP-214 6mg | MP-214 6mg: Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for twelve weeks. |
| FG002 | MP-214 9mg | MP-214 9mg: Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for twelve weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MP-214 3mg | MP-214 3mg: Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for twelve weeks. |
| BG001 | MP-214 6mg | MP-214 6mg: Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for twelve weeks. |
| 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 24 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 | MP-214 3mg: Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for twelve weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Schizophrenia | Psychiatric disorders | MedDRA 16.1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinus tachycardia | Cardiac disorders | MedDRA 16.1 |
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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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| MP-214 6mg | Drug | Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for twelve weeks. |
|
| MP-214 9mg | Drug | Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for twelve weeks. |
|
| Withdrawal by Subject |
|
| BG002 | MP-214 9mg | MP-214 9mg: Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for twelve weeks. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 84 | Posted | Mean | Standard Deviation | ng/mL | On Day 84 samples were taken pre-dose and 3, 4, 6 and 8 hours post-dose. |
|
|
|
| Primary | Time to Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 84 | Posted | Mean | Standard Deviation | hour | On Day 84 samples were taken pre-dose and 3, 4, 6 and 8 hours post-dose. |
|
|
|
| Primary | Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 84 | Posted | Mean | Standard Deviation | ng*h/mL | On Day 84 samples were taken pre-dose and 3, 4, 6 and 8 hours post-dose. |
|
|
|
| 0 |
| 11 |
| 11 |
| 11 |
| EG001 | MP-214 6mg | MP-214 6mg: Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for twelve weeks. | 2 | 16 | 15 | 16 |
| EG002 | MP-214 9mg | MP-214 9mg: Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for twelve weeks. | 0 | 11 | 11 | 11 |
| Hyperprolactinaemia | Endocrine disorders | MedDRA 16.1 |
|
| Abnormal sensation in eye | Eye disorders | MedDRA 16.1 |
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| Cataract | Eye disorders | MedDRA 16.1 |
|
| Conjunctivitis | Eye disorders | MedDRA 16.1 |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 16.1 |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 16.1 |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.1 |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.1 |
|
| Abdominal tenderness | Gastrointestinal disorders | MedDRA 16.1 |
|
| Constipation | Gastrointestinal disorders | MedDRA 16.1 |
|
| Dental caries | Gastrointestinal disorders | MedDRA 16.1 |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 |
|
| Faeces hard | Gastrointestinal disorders | MedDRA 16.1 |
|
| Gastritis | Gastrointestinal disorders | MedDRA 16.1 |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 16.1 |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 16.1 |
|
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA 16.1 |
|
| Mucous stools | Gastrointestinal disorders | MedDRA 16.1 |
|
| Nausea | Gastrointestinal disorders | MedDRA 16.1 |
|
| Paraesthesia oral | Gastrointestinal disorders | MedDRA 16.1 |
|
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA 16.1 |
|
| Vomiting | Gastrointestinal disorders | MedDRA 16.1 |
|
| Chest discomfort | General disorders | MedDRA 16.1 |
|
| Chills | General disorders | MedDRA 16.1 |
|
| Feeling abnormal | General disorders | MedDRA 16.1 |
|
| Irritability | General disorders | MedDRA 16.1 |
|
| Malaise | General disorders | MedDRA 16.1 |
|
| Pyrexia | General disorders | MedDRA 16.1 |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 16.1 |
|
| Seasonal allergy | Immune system disorders | MedDRA 16.1 |
|
| Enteritis infectious | Infections and infestations | MedDRA 16.1 |
|
| Gastroenteritis | Infections and infestations | MedDRA 16.1 |
|
| Hordeolum | Infections and infestations | MedDRA 16.1 |
|
| Nasopharyngitis | Infections and infestations | MedDRA 16.1 |
|
| Pulpitis dental | Infections and infestations | MedDRA 16.1 |
|
| Tinea infection | Infections and infestations | MedDRA 16.1 |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 16.1 |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 16.1 |
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| Laceration | Injury, poisoning and procedural complications | MedDRA 16.1 |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 16.1 |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 16.1 |
|
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 16.1 |
|
| Alanine aminotransferase increased | Investigations | MedDRA 16.1 |
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| Aspartate aminotransferase increased | Investigations | MedDRA 16.1 |
|
| Blood cholesterol increased | Investigations | MedDRA 16.1 |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 16.1 |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 16.1 |
|
| Blood prolactin increased | Investigations | MedDRA 16.1 |
|
| Blood triglycerides increased | Investigations | MedDRA 16.1 |
|
| Blood uric acid increased | Investigations | MedDRA 16.1 |
|
| Blood urine present | Investigations | MedDRA 16.1 |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 16.1 |
|
| Heart rate increased | Investigations | MedDRA 16.1 |
|
| Liver function test abnormal | Investigations | MedDRA 16.1 |
|
| Red blood cell count increased | Investigations | MedDRA 16.1 |
|
| Thyroxine free increased | Investigations | MedDRA 16.1 |
|
| Weight decreased | Investigations | MedDRA 16.1 |
|
| White blood cell count increased | Investigations | MedDRA 16.1 |
|
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA 16.1 |
|
| Electrolyte depletion | Metabolism and nutrition disorders | MedDRA 16.1 |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 16.1 |
|
| Metabolic disorder | Metabolism and nutrition disorders | MedDRA 16.1 |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.1 |
|
| Akathisia | Nervous system disorders | MedDRA 16.1 |
|
| Athetosis | Nervous system disorders | MedDRA 16.1 |
|
| Dizziness | Nervous system disorders | MedDRA 16.1 |
|
| Dizziness postural | Nervous system disorders | MedDRA 16.1 |
|
| Dyskinesia | Nervous system disorders | MedDRA 16.1 |
|
| Extrapyramidal disorder | Nervous system disorders | MedDRA 16.1 |
|
| Facial spasm | Nervous system disorders | MedDRA 16.1 |
|
| Headache | Nervous system disorders | MedDRA 16.1 |
|
| Restless legs syndrome | Nervous system disorders | MedDRA 16.1 |
|
| Sedation | Nervous system disorders | MedDRA 16.1 |
|
| Somnolence | Nervous system disorders | MedDRA 16.1 |
|
| Tremor | Nervous system disorders | MedDRA 16.1 |
|
| Hallucination, visual | Psychiatric disorders | MedDRA 16.1 |
|
| Insomnia | Psychiatric disorders | MedDRA 16.1 |
|
| Restlessness | Psychiatric disorders | MedDRA 16.1 |
|
| Schizophrenia | Psychiatric disorders | MedDRA 16.1 |
|
| Suicidal ideation | Psychiatric disorders | MedDRA 16.1 |
|
| Urinary retention | Renal and urinary disorders | MedDRA 16.1 |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 |
|
| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA 16.1 |
|
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA 16.1 |
|
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA 16.1 |
|
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA 16.1 |
|
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA 16.1 |
|
| Skin erosion | Skin and subcutaneous tissue disorders | MedDRA 16.1 |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 16.1 |
|
| Hot flush | Vascular disorders | MedDRA 16.1 |
|
| Hypertension | Vascular disorders | MedDRA 16.1 |
|
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|
| M6 (didesmethyl cariprazine) |
|
|
| M6 (didesmethyl cariprazine) |
|
|
| M6 (didesmethyl cariprazine) |
|