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| Sponsored by: |
Sumitomo Pharmaceuticals America |
|---|---|
| Information provided by: | Sumitomo Pharmaceuticals America |
| ClinicalTrials.gov Identifier: | NCT00088621 |
Purpose
A 1-year outpatient study to test the safety and tolerability of a new medication in the treatment of schizophrenia
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: SM-13496 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
| Official Title: | An Open-Label, Multicenter, Twelve-Month Study of Safety and Tolerability in the Treatment of Schizophrenia |
| Estimated Enrollment: | 100 |
| Study Start Date: | July 2004 |
| Estimated Study Completion Date: | December 2005 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Schizophrenia) and either:
Contacts and Locations| United States, Alabama | |
| Birmingham Psychiatry Pharmaceutical | |
| Birmingham, Alabama, United States, 35209 | |
| United States, Arkansas | |
| Summit Research Group | |
| Little Rock, Arkansas, United States, 72211 | |
| United States, California | |
| Collaborative Neuro Science Network, Inc. | |
| Garden Grove, California, United States, 92845 | |
| Comprehensive NeuroScience | |
| Cerritos, California, United States, 90703 | |
| Pacific Clinical Research | |
| Upland, California, United States, 91786 | |
| United States, District of Columbia | |
| Comprehensive NeuroScience, Inc | |
| Washington, District of Columbia, United States, 20016 | |
| United States, Florida | |
| Segal Institute for Clinical Research | |
| North Miami, Florida, United States, 33161 | |
| University of South Florida, Department of Psychiatry and Behavioral Medicine | |
| Tampa, Florida, United States, 33613 | |
| United States, Illinois | |
| Comprehensive Neuroscience, Inc. | |
| Hoffman Estates, Illinois, United States, 60194 | |
| United States, Nevada | |
| Las Vegas, Nevada, United States, 89102 | |
| United States, New Jersey | |
| CNS Research Institute | |
| Clementon, New Jersey, United States, 08021 | |
| United States, Pennsylvania | |
| Quantum Clinical Services Group | |
| Philadelphia, Pennsylvania, United States, 19139 | |
| United States, Texas | |
| Claghorn Lesem Research Clinic, Inc. | |
| Bellaire, Texas, United States, 77401 | |
| Community Clinical Research | |
| Austin, Texas, United States, 78729 | |
| Future Search Trials | |
| Austin, Texas, United States, 78756 | |
| InSite Clinical Research | |
| DeSoto, Texas, United States, 75115 | |
| United States, Virginia | |
| CBH Health, L.L.C - Dominion Hospital | |
| Falls Church, Virginia, United States, 22044 | |
More Information
| Study ID Numbers: | D1050199 |
| Study First Received: | July 30, 2004 |
| Last Updated: | April 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00088621 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Schizophrenia |
|
Schizophrenia Mental Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |
|
Schizophrenia Mental Disorders Schizophrenia and Disorders with Psychotic Features |
