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Safety and Efficacy Study of CEP-1347 in the Treatment of Parkinson's Disease
This study has been terminated.
First Received: June 26, 2002   Last Updated: November 9, 2007   History of Changes
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

Resource links provided by NLM:


Further study details as provided by Cephalon:

Estimated Enrollment: 800
Study Start Date: March 2002
  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Exclusion Criteria:

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00040404

  Hide Study Locations
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
Sponsors and Collaborators
Cephalon
H. Lundbeck A/S
The Parkinson Study Group
  More Information

Additional Information:
No publications provided by Cephalon

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
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

Keywords provided by Cephalon:
Parkinson's disease
Idiopathic Parkinson's disease
Idiopathic Parkinson disease
Parkinson's disease, idiopathic

Additional relevant MeSH terms:
Movement Disorders
Parkinson Disease
Nervous System Diseases
Basal Ganglia Diseases
Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

ClinicalTrials.gov processed this record on November 22, 2009