Safety and Efficacy Study of CEP-1347 in the Treatment of Parkinson's Disease
NCT ID: NCT00040404
Last Updated: 2012-05-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2/PHASE3
806 participants
INTERVENTIONAL
2002-03-31
2005-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CEP-1347 10mg
CEP-1347 was administered at a dosage of 10mg twice daily (bid); capsule strengths were 5, 12.5, and 25 mg. Each patient took 2 capsules at each dosing time, approximately 12 hours apart, within 30 minutes after the morning and evening meals) for a total of 4 capsules per day.Patients were randomly assigned to CEP-1347 or placebo treatment in a 1:1:1:1 ratio. A blocked randomization scheme was used to ensure approximately equal numbers of patients in each of the 4 treatment groups at each center.
CEP-1347 10mg
CEP-1347 10mg, a K252a derivative, retains neuroprotective properties
CEP-1347 25mg
CEP-1347 was administered at a dosage of 25mg twice daily (bid); capsule strengths were 5, 12.5, and 25 mg. Each patient took 2 capsules at each dosing time, approximately 12 hours apart, within 30 minutes after the morning and evening meals) for a total of 4 capsules per day.Patients were randomly assigned to CEP-1347 or placebo treatment in a 1:1:1:1 ratio. A blocked randomization scheme was used to ensure approximately equal numbers of patients in each of the 4 treatment groups at each center.
CEP1347 25mg
CEP1347 25mg, a K252a derivative, retains neuroprotective properties
CEP-1347 50mg
CEP-1347 was administered at a dosage of 50mg twice daily (bid); capsule strengths were 5, 12.5, and 25 mg. Each patient took 2 capsules at each dosing time, approximately 12 hours apart, within 30 minutes after the morning and evening meals) for a total of 4 capsules per day.Patients were randomly assigned to CEP-1347 or placebo treatment in a 1:1:1:1 ratio. A blocked randomization scheme was used to ensure approximately equal numbers of patients in each of the 4 treatment groups at each center.
CEP-1347 50mg
CEP-1347 50mg, a K252a derivative, retains neuroprotective properties
Placebo
Placebo capsules matching the CEP-1347 capsules were administered in the same manner.
Placebo Comparator
Placebo capsules matching the CEP-1347 capsules
Interventions
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CEP-1347 10mg
CEP-1347 10mg, a K252a derivative, retains neuroprotective properties
CEP1347 25mg
CEP1347 25mg, a K252a derivative, retains neuroprotective properties
CEP-1347 50mg
CEP-1347 50mg, a K252a derivative, retains neuroprotective properties
Placebo Comparator
Placebo capsules matching the CEP-1347 capsules
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
30 Years
ALL
No
Sponsors
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H. Lundbeck A/S
INDUSTRY
The Parkinson Study Group
NETWORK
Cephalon
INDUSTRY
Responsible Party
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Locations
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Barrow Neurological Institute
Phoenix, Arizona, United States
Mayo Clinic Arizona
Scottsdale, Arizona, United States
University of Arkansas for Medical Services
Little Rock, Arkansas, United States
The Parkinson's and Movement Disorders Institute
Fountain Valley, California, United States
University of California Irvine
Irvine, California, United States
USC, Keck School of Pharmacy, Department of Neurology
Los Angeles, California, United States
California Medical Clinic for Movement Disorders
Oxnard, California, United States
Department of Neurology - UC Davis Medical Center
Sacramento, California, United States
University of California San Diego
San Diego, California, United States
Stanford University Medical Center, Dept. of Neurology
Stanford, California, United States
The Parkinson's Institute
Sunnyvale, California, United States
University of Colorado Health Sciences Center
Denver, Colorado, United States
Colorado Neurological Institute/Movement Disorders Center
Englewood, Colorado, United States
University of Connecticut Health Center
Farmington, Connecticut, United States
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States
Davis Building - Neurology 8-B
Jacksonville, Florida, United States
University of South Florida, Harbourside Medical Tower
Tampa, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
Medical College of Georgia
Augusta, Georgia, United States
Northwestern University, Department of Neurology
Chicago, Illinois, United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Indiana University of Medicine/Outpatient Clinical Research Facility
Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics, Department of Neurology
Iowa City, Iowa, United States
University of Kansas Medical Center/Dept. of Neurology
Kansas City, Kansas, United States
LSUHSC in Shreveport
Shreveport, Louisiana, United States
University of Maryland
Baltimore, Maryland, United States
Johns Hopkins University, Department of Neurology
Baltimore, Maryland, United States
Center for Aging, Genetics and Neurodegeneration, Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Womens Hospital/Neurology
Boston, Massachusetts, United States
Boston University Medical Center, Department of Neurology
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Clinical Neuroscience Center
Southfield, Michigan, United States
University of Minnesota, Department of Neurology
Minneapolis, Minnesota, United States
Washington University
St Louis, Missouri, United States
Creighton University/Department of Neurology
Omaha, Nebraska, United States
UMDNJ Robert Wood Johnson Medical Center
New Brunswick, New Jersey, United States
University of Medicine and Dentistry of New Jersey/Center for Aging
Stratford, New Jersey, United States
Parkinson's Disease & Movement Disorders Center of AMC
Albany, New York, United States
Movement Disorders Center/North Shore - LIJ Health System
Manhasset, New York, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
Beth Israel Medical Center, Department of Neurology
New York, New York, United States
Columbia Presbyterian Medical Center, Neurological Institute
New York, New York, United States
University of Rochester, Department of Neurology
Rochester, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Medical College of Ohio, Department of Neurology
Toledo, Ohio, United States
Oregon Health Sciences University/Dept. of Neurology
Portland, Oregon, United States
Pennsylvania Hospital/Dept. of Neurology
Philadelphia, Pennsylvania, United States
Brown University/Memorial Hospital of Rhode Island/Neurology Dept.
Pawtucket, Rhode Island, United States
University of Tennessee Memphis, Semmes Murphy Clinic
Memphis, Tennessee, United States
Parkinson's Disease Center and Movement Disorders Clinic/Baylor College of Medicine
Houston, Texas, United States
Scott and White Clinic/Texas A & M University
Temple, Texas, United States
University of Virginia Health System/Adult Neurology
Charlottesville, Virginia, United States
Medical College of Wisconsin, Department Neurology
Milwaukee, Wisconsin, United States
University of Calgary
Calgary, Alberta, Canada
University of Alberta - Glenrose Rehab Hospital
Edmonton, Alberta, Canada
London Health Sciences Center - University Campus
London, Ontario, Canada
Ottawa Hospital, Civic Site
Ottawa, Ontario, Canada
Toronto Hospital Western Division
Toronto, Ontario, Canada
University of Sherbrooke
Fleurimont, Quebec, Canada
Centre Hospitalier De L'Universite Montreal
Montreal, Quebec, Canada
McGill Center for Studies in Aging
Verdun, Quebec, Canada
Saskatoon District Health Board - Royal University Hospital
Saskatoon, Saskatchewan, Canada
University of Puerto Rico, Clinical Research Center
San Juan, , Puerto Rico
Countries
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References
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Schwarzschild MA, Schwid SR, Marek K, Watts A, Lang AE, Oakes D, Shoulson I, Ascherio A; Parkinson Study Group PRECEPT Investigators; Hyson C, Gorbold E, Rudolph A, Kieburtz K, Fahn S, Gauger L, Goetz C, Seibyl J, Forrest M, Ondrasik J. Serum urate as a predictor of clinical and radiographic progression in Parkinson disease. Arch Neurol. 2008 Jun;65(6):716-23. doi: 10.1001/archneur.2008.65.6.nct70003. Epub 2008 Apr 14.
Parkinson Study Group PRECEPT Investigators. Mixed lineage kinase inhibitor CEP-1347 fails to delay disability in early Parkinson disease. Neurology. 2007 Oct 9;69(15):1480-90. doi: 10.1212/01.wnl.0000277648.63931.c0. Epub 2007 Sep 19.
Related Links
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The Parkinson Study Group (PSG) is a non-profit, cooperative group of Parkinson's disease experts from medical centers in the United States and Canada who are dedicated to improving treatment for persons affected by Parkinson's disease.
Other Identifiers
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C1347c/204/PD/US-CA
Identifier Type: -
Identifier Source: org_study_id
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