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| Sponsor: | Cephalon |
|---|---|
| Collaborators: |
H. Lundbeck A/S The Parkinson Study Group |
| Information provided by: | Cephalon |
| ClinicalTrials.gov Identifier: | NCT00040404 |
Purpose
The purpose of this study is to establish safety for CEP-1347 and to determine an efficacious dose in the treatment of Parkinson's disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson Disease |
Drug: CEP-1347 |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Efficacy and Safety of CEP-1347 in Patients With Parkinson's Disease |
Eligibility| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients will be included in the study if all of the following criteria are met:
Exclusion Criteria:
Patients will be excluded from participating in this study if 1 or more of the following criteria are met:
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Barrow Neurological Institute | |
| Phoenix, Arizona, United States, 85013 | |
| Mayo Clinic Arizona | |
| Scottsdale, Arizona, United States, 85259 | |
| United States, Arkansas | |
| University of Arkansas for Medical Services | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| The Parkinson's Institute | |
| Sunnyvale, California, United States, 94089 | |
| Department of Neurology - UC Davis Medical Center | |
| Sacramento, California, United States, 95817 | |
| USC, Keck School of Pharmacy, Department of Neurology | |
| Los Angeles, California, United States, 90033-0046 | |
| Stanford University Medical Center, Dept. of Neurology | |
| Stanford, California, United States, 94305 | |
| The Parkinson's and Movement Disorders Institute | |
| Fountain Valley, California, United States, 92708 | |
| California Medical Clinic for Movement Disorders | |
| Oxnard, California, United States, 93030 | |
| University of California Irvine | |
| Irvine, California, United States, 92697-4275 | |
| University of California San Diego | |
| San Diego, California, United States, 92161 | |
| United States, Colorado | |
| Colorado Neurological Institute/Movement Disorders Center | |
| Englewood, Colorado, United States, 80110 | |
| University of Colorado Health Sciences Center | |
| Denver, Colorado, United States, 80262 | |
| United States, Connecticut | |
| Institute for Neurodegenerative Disorders | |
| New Haven, Connecticut, United States, 06510 | |
| University of Connecticut Health Center | |
| Farmington, Connecticut, United States, 06030 | |
| United States, Florida | |
| Davis Building - Neurology 8-B | |
| Jacksonville, Florida, United States, 32224 | |
| University of South Florida, Harbourside Medical Tower | |
| Tampa, Florida, United States, 33606 | |
| Cleveland Clinic Florida | |
| Weston, Florida, United States, 33331 | |
| United States, Georgia | |
| Medical College of Georgia | |
| Augusta, Georgia, United States, 30912 | |
| United States, Illinois | |
| Rush-Presbyterian-St. Luke's Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
| Northwestern University, Department of Neurology | |
| Chicago, Illinois, United States, 60611 | |
| United States, Indiana | |
| Indiana University of Medicine/Outpatient Clinical Research Facility | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Iowa | |
| University of Iowa Hospitals and Clinics, Department of Neurology | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Kansas | |
| University of Kansas Medical Center/Dept. of Neurology | |
| Kansas City, Kansas, United States, 66160 | |
| United States, Louisiana | |
| LSUHSC in Shreveport | |
| Shreveport, Louisiana, United States, 71130 | |
| United States, Maryland | |
| Johns Hopkins University, Department of Neurology | |
| Baltimore, Maryland, United States, 21287 | |
| University of Maryland | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Massachusetts | |
| Boston University Medical Center, Department of Neurology | |
| Boston, Massachusetts, United States, 02118 | |
| Center for Aging, Genetics and Neurodegeneration, Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Brigham and Womens Hospital/Neurology | |
| Boston, Massachusetts, United States, 02115 | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Michigan | |
| Clinical Neuroscience Center | |
| Southfield, Michigan, United States, 48034 | |
| United States, Minnesota | |
| University of Minnesota, Department of Neurology | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Missouri | |
| Washington University | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Nebraska | |
| Creighton University/Department of Neurology | |
| Omaha, Nebraska, United States, 68131 | |
| United States, New Jersey | |
| University of Medicine and Dentistry of New Jersey/Center for Aging | |
| Stratford, New Jersey, United States, 08084 | |
| UMDNJ Robert Wood Johnson Medical Center | |
| New Brunswick, New Jersey, United States, 08901 | |
| United States, New York | |
| Parkinson's Disease & Movement Disorders Center of AMC | |
| Albany, New York, United States, 12205 | |
| Long Island Jewish Medical Center | |
| New Hyde Park, New York, United States, 11040 | |
| Movement Disorders Center/North Shore - LIJ Health System | |
| Manhasset, New York, United States, 11030 | |
| University of Rochester, Department of Neurology | |
| Rochester, New York, United States, 14642 | |
| Beth Israel Medical Center, Department of Neurology | |
| New York, New York, United States, 10003 | |
| Columbia Presbyterian Medical Center, Neurological Institute | |
| New York, New York, United States, 10032 | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27705 | |
| United States, Ohio | |
| Medical College of Ohio, Department of Neurology | |
| Toledo, Ohio, United States, 43614 | |
| University of Cincinnati | |
| Cincinnati, Ohio, United States, 45267-0525 | |
| Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Oregon | |
| Oregon Health Sciences University/Dept. of Neurology | |
| Portland, Oregon, United States, 97201-3098 | |
| United States, Pennsylvania | |
| Pennsylvania Hospital/Dept. of Neurology | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, Rhode Island | |
| Brown University/Memorial Hospital of Rhode Island/Neurology Dept. | |
| Pawtucket, Rhode Island, United States, 02860 | |
| United States, Tennessee | |
| University of Tennessee Memphis, Semmes Murphy Clinic | |
| Memphis, Tennessee, United States, 38104 | |
| United States, Texas | |
| Scott and White Clinic/Texas A & M University | |
| Temple, Texas, United States, 76508 | |
| Parkinson's Disease Center and Movement Disorders Clinic/Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| United States, Virginia | |
| University of Virginia Health System/Adult Neurology | |
| Charlottesville, Virginia, United States, 22903 | |
| United States, Wisconsin | |
| Medical College of Wisconsin, Department Neurology | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Canada, Alberta | |
| University of Alberta - Glenrose Rehab Hospital | |
| Edmonton, Alberta, Canada, T5G 0B7 | |
| University of Calgary | |
| Calgary, Alberta, Canada, T2N 2N1 | |
| Canada, Ontario | |
| Ottawa Hospital, Civic Site | |
| Ottawa, Ontario, Canada, K1Y 4E9 | |
| London Health Sciences Center - University Campus | |
| London, Ontario, Canada, N6A 5A5 | |
| Toronto Hospital Western Division | |
| Toronto, Ontario, Canada, M5T 2S8 | |
| Canada, Quebec | |
| McGill Center for Studies in Aging | |
| Verdun, Quebec, Canada, H4H 1R3 | |
| Centre Hospitalier De L'Universite Montreal | |
| Montreal, Quebec, Canada, H2W 1T8 | |
| University of Sherbrooke | |
| Fleurimont, Quebec, Canada, J1H 5N4 | |
| Canada, Saskatchewan | |
| Saskatoon District Health Board - Royal University Hospital | |
| Saskatoon, Saskatchewan, Canada, S7N 0W8 | |
| Puerto Rico | |
| University of Puerto Rico, Clinical Research Center | |
| San Juan, Puerto Rico, 00901 | |
More Information
| Study ID Numbers: | C1347c/204/PD/US-CA |
| Study First Received: | June 26, 2002 |
| Last Updated: | November 9, 2007 |
| ClinicalTrials.gov Identifier: | NCT00040404 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Parkinson's disease Idiopathic Parkinson's disease Idiopathic Parkinson disease Parkinson's disease, idiopathic |
|
Movement Disorders Parkinson Disease Nervous System Diseases Basal Ganglia Diseases |
Central Nervous System Diseases Parkinsonian Disorders Neurodegenerative Diseases Brain Diseases |