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A 1-year outpatient study to test the safety and tolerability of a new medication in the treatment of schizophrenia
Study will evaluate long-term safety and tolerability of a new compound in the treatment of patients with schizophrenia as assessed by adverse events (AEs), measures of extra pyramidal symptoms (EPS; Abnormal Involuntary Movement Scale [AIMS], Barnes Akathisia Scale [BAS], and Simpson-Angus Rating Scale [SAS]), vital sign measurements, electrocardiograms (ECGs), clinical laboratory evaluations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lurasidone 80 mg tablet | Experimental | Lurasidone 80mg oral tablet taken once a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lurasidone 80mg tablet | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With an Adverse Events in a One Year Open Label Lurasidone Study | 1 year |
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director, MD | Sumitomo Pharma America, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham Psychiatry Pharmaceutical | Birmingham | Alabama | 35209 | United States | ||
| Summit Research Group |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lurasidone 80 mg | Lurasidone 80mg oral tablet. The number of subjects that represent the participant flow is based on the number of subjects that entered the extension study which is 61 subjects. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Little Rock |
| Arkansas |
| 72211 |
| United States |
| Comprehensive NeuroScience | Cerritos | California | 90703 | United States |
| Collaborative Neuro Science Network, Inc. | Garden Grove | California | 92845 | United States |
| Optimum Health Services | La Mesa | California | 91942 | United States |
| California Clinical Trials | San Diego | California | 92123 | United States |
| CA Neutopsychopharmacology Clinical Research Institute (CNRI) | San Diego | California | 92126 | United States |
| Pacific Clinical Research | Upland | California | 91786 | United States |
| Comprehensive NeuroScience, Inc | Washington D.C. | District of Columbia | 20016 | United States |
| Segal Institute for Clinical Research | Fort Lauderdale | Florida | 33301 | United States |
| Segal Institute for Clinical Research | North Miami | Florida | 33161 | United States |
| University of South Florida, Department of Psychiatry and Behavioral Medicine | Tampa | Florida | 33613 | United States |
| Comprehensive Neuroscience, Inc. | Hoffman Estates | Illinois | 60194 | United States |
| Las Vegas | Nevada | 89102 | United States |
| CNS Research Institute | Clementon | New Jersey | 08021 | United States |
| Quantum Clinical Services Group | Philadelphia | Pennsylvania | 19139 | United States |
| Community Clinical Research | Austin | Texas | 78729 | United States |
| Future Search Trials | Austin | Texas | 78756 | United States |
| Claghorn Lesem Research Clinic, Inc. | Bellaire | Texas | 77401 | United States |
| InSite Clinical Research | DeSoto | Texas | 75115 | United States |
| CBH Health, L.L.C - Dominion Hospital | Falls Church | Virginia | 22044 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Lurasidone 80 mg | Lurasidone 80mg oral tablet. The number of subjects that represent the baseline must have taken 1 dose of study medication and had post-baseline assessment. 2 subjects were randomized and did not take study medication and thus 59 subjects is listed in the baseline group. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | 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 Subjects With an Adverse Events in a One Year Open Label Lurasidone Study | Number of subjects that entered into the extension trial. | Posted | Feb 2011 | Number | participants | 1 year |
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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 | Lurasidone 80 mg | Lurasidone 80mg oral tablet. The number of subjects that represent the baseline must have taken 1 dose of study medication and had post-baseline assessment. 2 subjects were randomized and did not take study medication and thus 59 subjects is listed in the baseline group. | 12 | 59 | 18 | 59 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pericardial Effusion | Cardiac disorders |
| |||
| Orchitis | Infections and infestations |
| |||
| Pneumonia | Infections and infestations |
| |||
| Sepsis | Infections and infestations |
| |||
| Cerebrovascular Accident | Nervous system disorders |
| |||
| Schizophrenia | Psychiatric disorders |
| |||
| Self Injurious Behavior | Psychiatric disorders |
| |||
| Prostatitis | Reproductive system and breast disorders |
| |||
| Pulmonary Mass | Respiratory, thoracic and mediastinal disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders |
| |||
| Vomiting | Gastrointestinal disorders |
| |||
| Bronchitis | Infections and infestations |
| |||
| Nasopharyngitis | Infections and infestations |
| |||
| Upper Respiratory Tract Infection | Infections and infestations |
| |||
| Weight Decreased | Investigations |
| |||
| Weight Increased | Investigations |
| |||
| Sedation | Nervous system disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Josephine Cucchiaro, Executive Director | Sunovion | 201-592-2050 | josephine.cucchiaro@sunovion.com |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069056 | Lurasidone Hydrochloride |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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