Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this study is to evaluate the efficacy, safety, and tolerability of MP-214 relative to placebo in patients with acute exacerbation of schizophrenia.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MP-214 3mg | Experimental |
| |
| MP-214 6mg | Experimental |
| |
| MP-214 9mg | Experimental |
| |
| Risperidone 4mg | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| 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 six weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 | 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. | Baseline and Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Clinical Global Impression-Severity (CGI-S) Score at Week 6 | 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). | Baseline and Week 6 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
The information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sapporo | Hokkaido | Japan | ||||
Four subjects withdrew from the study before the start of the study medication after being assigned to the treatment.
Not provided
Not provided
| 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 six 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 six 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 six weeks. |
| FG003 | Risperidone 4mg | Risperidone 4mg: Patients who meet eligibility criteria will be administered a once daily oral 4mg of risperidone for six weeks. |
| FG004 | Placebo | Placebo: Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| 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 six 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 six 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 | Change in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 | 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. | For OC (Observed Case) analysis, the Missing Values were Not included. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Week 6 |
|
Not provided
Not provided
Not provided
| 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 six weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sudden death | General disorders | MedDRA 18.1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 18.1 |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials, Information Desk | Tanabe Pharma Corporation | cti-inq-ml.JP@ml.tanabe-pharma.com |
Not provided
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D018967 | Risperidone |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| MP-214 6mg | Drug | Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for six weeks. |
|
| MP-214 9mg | Drug | Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for six weeks. |
|
| Risperidone 4mg | Drug | Patients who meet eligibility criteria will be administered a once daily oral 4mg of risperidone for six weeks. |
|
| Placebo | Drug | Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks. |
|
| Seoul |
| South Korea |
| Taipei | Taiwan |
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Adverse Event (including Death) |
|
| BG002 | MP-214 9mg | MP-214 9mg: Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for six weeks. |
| BG003 | Risperidone 4mg | Risperidone 4mg: Patients who meet eligibility criteria will be administered a once daily oral 4mg of risperidone for six weeks. |
| BG004 | Placebo | Placebo: Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks. |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
MP-214 6mg: Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for six weeks. |
| OG002 | MP-214 9mg | MP-214 9mg: Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for six weeks. |
| OG003 | Risperidone 4mg | Risperidone 4mg: Patients who meet eligibility criteria will be administered a once daily oral 4mg of risperidone for six weeks. |
| OG004 | Placebo | Placebo: Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks. |
|
|
| Secondary | Change in the Clinical Global Impression-Severity (CGI-S) Score at Week 6 | 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). | For OC (Observed Case) analysis, the Missing Values were Not included. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Week 6 |
|
|
|
| 12 |
| 126 |
| 95 |
| 126 |
| EG001 | MP-214 6mg | MP-214 6mg: Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for six weeks. | 16 | 133 | 100 | 133 |
| EG002 | MP-214 9mg | MP-214 9mg: Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for six weeks. | 4 | 67 | 52 | 67 |
| EG003 | Risperidone 4mg | Risperidone 4mg: Patients who meet eligibility criteria will be administered a once daily oral 4mg of risperidone for six weeks. | 2 | 56 | 36 | 56 |
| EG004 | Placebo | Placebo: Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks. | 14 | 126 | 72 | 126 |
| Infection masked | Infections and infestations | MedDRA 18.1 |
|
| Pneumonia | Infections and infestations | MedDRA 18.1 |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 18.1 |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 |
|
| Akathisia | Nervous system disorders | MedDRA 18.1 |
|
| Altered state of consciousness | Nervous system disorders | MedDRA 18.1 |
|
| Extrapyramidal disorder | Nervous system disorders | MedDRA 18.1 |
|
| Neuroleptic malignant syndrome | Nervous system disorders | MedDRA 18.1 |
|
| Agitation | Psychiatric disorders | MedDRA 18.1 |
|
| Schizophrenia | Psychiatric disorders | MedDRA 18.1 |
|
| Suicidal behaviour | Psychiatric disorders | MedDRA 18.1 |
|
| Suicidal ideation | Psychiatric disorders | MedDRA 18.1 |
|
| Suicide attempt | Psychiatric disorders | MedDRA 18.1 |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 18.1 |
|
| Nausea | Gastrointestinal disorders | MedDRA 18.1 |
|
| Vomiting | Gastrointestinal disorders | MedDRA 18.1 |
|
| Nasopharyngitis | Infections and infestations | MedDRA 18.1 |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 18.1 |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 18.1 |
|
| Liver function test abnormal | Investigations | MedDRA 18.1 |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.1 |
|
| Myalgia | 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 |
|
| Insomnia | Psychiatric disorders | MedDRA 18.1 |
|
| Restlessness | Psychiatric disorders | MedDRA 18.1 |
|
| Schizophrenia | Psychiatric disorders | MedDRA 18.1 |
|
| Hypertension | Vascular disorders | MedDRA 18.1 |
|
Not provided