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Safety and efficacy study of CEP-1347 in the treatment of Parkinson's disease Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Safety and efficacy study of CEP-1347 in the treatment of Parkinson's disease conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Safety and efficacy study of CEP-1347 in the treatment of Parkinson's disease Clinical research trials and Safety and efficacy study of CEP-1347 in the treatment of Parkinson's disease healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Safety and efficacy study of CEP-1347 in the treatment of Parkinson's disease. Safety and efficacy study of CEP-1347 in the treatment of Parkinson's disease Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Safety and efficacy study of CEP-1347 in the treatment of Parkinson's disease clinical trial. Human subjects often obtain the finest healthcare possible for their Safety and efficacy study of CEP-1347 in the treatment of Parkinson's disease condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Safety and efficacy study of CEP-1347 in the treatment of Parkinson's disease  Safety and efficacy study of CEP-1347 in the treatment of Parkinson's disease
Safety and efficacy study of CEP-1347 in the treatment of Parkinson's disease
For Condition: Parkinson Disease
Status: No longer recruiting
Sponsor(s): Cephalon , H. Lundbeck A/S,The Parkinson Study Group
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 30 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients will be included in the study if all of the following criteria are met: - willing and able to give informed consent - age 30 years or older at time of diagnosis of Parkinson’s disease - have idiopathic Parkinson’s disease with at least 2 cardinal signs of disease: resting tremor, bradykinesia, or rigidity - Modified Hoehn and Yahr stage less than or equal to 2.5 - must have had screening procedures for cancer appropriate for the patient’s age and gender, within the last 12 months; or be willing to obtain such screening before randomization - women: are not breastfeeding - women: nonchildbearing potential (ie, postmenopausal or surgically sterile) or must use a medically accepted contraceptive regimen for at least 60 days before the baseline visit, and agree to continue such use throughout the duration of the study and for 30 days after the final dose of study drug. Women must be given a pregnancy test unless they are at least 2 years postmenopausal or surgically sterile. Main Criteria for Exclusion Patients will be excluded from participating in this study if 1 or more of the following criteria are met: - have atypical Parkinsonism due to drugs, metabolic disorders, encephalitis, or other neurodegenerative diseases - have confirmed diagnosis of Parkinson’s disease for more than 5 years - have a tremor score of 3 or more in any body part - have any other known medical or psychiatric condition that may compromise participation in the study - have a history of prior malignancy (excluding basal or squamous cell cancer of the skin) within the previous 5 years - have an unresolved abnormal cancer screening test result before randomization - have greater than trace amounts of glycosuria at screening, except for known diabetic patients - have estimated creatinine clearance less than 50 mL/min - have liver function tests (LFT) greater than 3 times the upper limit of normal (ULN) - have any other clinically significant ECG or laboratory finding - have any history of malignant melanoma - have history of seizures (except febrile) or posttraumatic epilepsy - have Mini-Mental State Exam (MMSE) score 26 - have taken another investigational drug within 60 days before the baseline visit - have received prior treatment with CEP-1347 - have received treatment with agents with potentially confounding anti-Parkinson’s disease effects, with specified substrates for CYP3A4/5, or with inhibitors of CYP3A4/5 - received treatment within 6 months before the baseline visit with agents that may induce Parkinson’s disease - are expected, within the next 3 months, to reach a level of disability sufficient to require dopaminergic therapy - have BECK depression score 15 - have known or suspected sensitivity to the investigational study drugs, including B-CIT
Total Enrollment: 800
Location and Contact Information:
Parkinson's Disease Center and Movement Disorders Clinic/Baylor College of Medicine
Houston, Texas, 77030
United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612
United States
Brigham and Womens Hospital/Neurology
Boston, Massachusetts, 02115
United States
Oregon Health Sciences University/Dept. of Neurology
Portland, Oregon, 97201-3098
United States
Centre Hospitalier De L'Universite Montreal
Montreal, Quebec, H2W 1T8
Canada
Barrow Neurological Institute
Phoenix, Arizona, 85013
United States
Pennsylvania Hospital/Dept. of Neurology
Philadelphia, Pennsylvania, 19107
United States
Brown University/Memorial Hospital of Rhode Island/Neurology Dept.
Pawtucket, Rhode Island, 02860
United States
University of Rochester, Department of Neurology
Rochester, New York, 14642
United States
Stanford University Medical Center, Dept. of Neurology
Stanford, California, 94305
United States
University of Calgary
Calgary, Alberta, T2N 2N1
Canada
University of South Florida, Harbourside Medical Tower
Tampa, Florida, 33606
United States
Northwestern University, Department of Neurology
Chicago, Illinois, 60611
United States
University of Sherbrooke
Fleurimont, Quebec, J1H 5N4
Canada
Beth Israel Medical Center, Department of Neurology
New York City, New York, 10003
United States
University of Connecticut Health Center
Farmington, Connecticut, 06030
United States
Medical College of Ohio, Department of Neurology
Toledo, Ohio, 43614
United States
Columbia Presbyterian Medical Center, Neurological Institute
New York City, New York, 10032
United States
Cleveland Clinic Florida
Weston, Florida, 33331
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
University of Colorado Health Sciences Center
Denver, Colorado, 80262
United States
LSUHSC in Shreveport
Shreveport, Louisiana, 71130
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
California Medical Clinic for Movement Disorders
Oxnard, California, 93030
United States
University of Cincinnati
Cincinnati, Ohio, 45267-0525
United States
University of Chicago
Chicago, Illinois, 60637
United States
Ottawa Hospital, Civic Site
Ottawa, Ontario, K1Y 4E9
Canada
UMDNJ Robert Wood Johnson Medical Center
New Brunswick, New Jersey, 08901
United States
Movement Disorders Center/North Shore - LIJ Health System
Manhasset, New York, 11030
United States
Duke University Medical Center
Durham, North Carolina, 27705
United States
The Parkinson's and Movement Disorders Institute
Fountain Valley, California, 92708
United States
USC, Keck School of Pharmacy, Department of Neurology
Los Angeles, California, 90033-0046
United States
Johns Hopkins University, Department of Neurology
Baltimore, Maryland, 21287
United States
Saskatoon District Health Board - Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8
Canada
University of Iowa Hospitals and Clinics, Department of Neurology
Iowa City, Iowa, 52242
United States
University of California Irvine
Irvine, California, 92697-4275
United States
Colorado Neurological Institute/Movement Disorders Center
Englewood, Colorado, 80110
United States
University of Minnesota, Department of Neurology
Minneapolis, Minnesota, 55455
United States
Institute for Neurodegenerative Disorders
New Haven, Connecticut, 06510
United States
University of Alberta - Glenrose Rehab Hospital
Edmonton, Alberta, T5G 0B7
Canada
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
United States
Medical College of Wisconsin, Department Neurology
Milwaukee, Wisconsin, 53226
United States
Boston University Medical Center, Department of Neurology
Boston, Massachusetts, 02118
United States
Department of Neurology - UC Davis Medical Center
Sacramento, California, 95817
United States
McGill Center for Studies in Aging
Verdun, Quebec, H4H 1R3
Canada
University of Medicine and Dentistry of New Jersey/Center for Aging
Stratford, New Jersey, 08084
United States
Creighton University/Department of Neurology
Omaha, Nebraska, 68131
United States
Clinical Neuroscience Center
Southfield, Michigan, 48034
United States
The Parkinson's Institute
Sunnyvale, California, 94089
United States
Washington University
St. Louis, Missouri, 63110
United States
Indiana University of Medicine/Outpatient Clinical Research Facility
Indianapolis, Indiana, 46202
United States
Parkinson's Disease & Movement Disorders Center of AMC
Albany, New York, 12205
United States
University of Maryland
Baltimore, Maryland, 21201
United States
Mayo Clinic Arizona
Scottsdale, Arizona, 85259
United States
University of California San Diego
San Diego, California, 92161
United States
Toronto Hospital Western Division
Toronto, Ontario, M5T 2S8
Canada
University of Virginia Health System/Adult Neurology
Charlottesville, Virginia, 22903
United States
Davis Building - Neurology 8-B
Jacksonville, Florida, 32224
United States
Scott and White Clinic/Texas A & M University
Temple, Texas, 76508
United States
London Health Sciences Center - University Campus
London, Ontario, N6A 5A5
Canada
University of Kansas Medical Center/Dept. of Neurology
Kansas City, Kansas, 66160
United States
Center for Aging, Genetics and Neurodegeneration, Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
University of Tennessee Memphis, Semmes Murphy Clinic
Memphis, Tennessee, 38104
United States
University of Puerto Rico, Clinical Research Center
San Juan, , 00901
Puerto Rico
University of Arkansas for Medical Services
Little Rock, Arkansas, 72205
United States
Medical College of Georgia
Augusta, Georgia, 30912
United States
Additional Information:
Study ID Numbers: C1347c/204/PD/US-CA;
Study Start Date: March 2002
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00040404
Other Parkinson Disease Studies:
1. An Open-Label, Long-Term, Flexible Dose Study of Safety, Tolerability, and Therapeutic Response In Patients with Parkinson's Disease with an Investigational Drug
2. Studying Automatic Movements in Patients with Parkinson's Disease
3. Investigating the Safety of srTMS in the Treatment of Parkinson's Disease
4. Randomized Study of Fetal Neurotransplantation for the Treatment of Parkinson's Disease
5. Study of Axial Mobility Exercises in Parkinson Disease
Related Studies:
Other Parkinson Disease Clinical Trials
Other Ohio Clinical Trials
Other Cincinnati Clinical Trials
Safety and efficacy study of CEP-1347 in the treatment of Parkinson's disease
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