Safety and Efficacy Study of CEP-1347 in the Treatment of Parkinson's Disease
- Conditions
- Parkinson Disease
- Interventions
- Registration Number
- NCT00040404
- Lead Sponsor
- Cephalon
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 806
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.
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CEP-1347 10mg 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 50mg 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 25mg CEP1347 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. Placebo Placebo Comparator Placebo capsules matching the CEP-1347 capsules were administered in the same manner.
- Primary Outcome Measures
Name Time Method Number of participants with disability using United Parkinson's Disease Rating Scale (UPDRS) 48 months Number of participants with disability sufficient to require dopaminergic therapy was assessed according to the United Parkinson's Disease Rating Scale (UPDRS) Parts I and II are historical data and are designed to rate mentation, behavior and mood; Part III is done as a motor examination at the time of a visit. The UPDRS measures patient status on a scale 0, which is normal or none, to 4, which is severe or the worst scenario.
- Secondary Outcome Measures
Name Time Method Change from Baseline to 22 months in ([123I]β-CIT) Uptake Participants Change from Baseline to 22 months The effect of CEP-1347 on dopaminergic transporter density using 2β-carboxymethoxy-3β-(4-iodophenyl) tropane (\[123I\]β-CIT) single-photon emission computed tomography (SPECT) imaging
Safety and Tolerability as assessed by the number of participants experiencing adverse events 48 months Safety was assessed by adverse events (including deaths, serious adverse events, and withdrawals due to adverse events.)
Trial Locations
- Locations (66)
Movement Disorders Center/North Shore - LIJ Health System
🇺🇸Manhasset, New York, United States
Pennsylvania Hospital/Dept. of Neurology
🇺🇸Philadelphia, Pennsylvania, United States
Toronto Hospital Western Division
🇨🇦Toronto, Ontario, Canada
University of Arkansas for Medical Services
🇺🇸Little Rock, Arkansas, United States
Davis Building - Neurology 8-B
🇺🇸Jacksonville, Florida, United States
LSUHSC in Shreveport
🇺🇸Shreveport, Louisiana, United States
University of Maryland
🇺🇸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
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
London Health Sciences Center - University Campus
🇨🇦London, Ontario, Canada
University of Alberta - Glenrose Rehab Hospital
🇨🇦Edmonton, Alberta, Canada
Boston University Medical Center, Department of Neurology
🇺🇸Boston, Massachusetts, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Parkinson's Disease Center and Movement Disorders Clinic/Baylor College of Medicine
🇺🇸Houston, Texas, United States
Colorado Neurological Institute/Movement Disorders Center
🇺🇸Englewood, Colorado, United States
Mayo Clinic Arizona
🇺🇸Scottsdale, Arizona, United States
California Medical Clinic for Movement Disorders
🇺🇸Oxnard, California, United States
The Parkinson's and Movement Disorders Institute
🇺🇸Fountain Valley, California, United States
USC, Keck School of Pharmacy, Department of Neurology
🇺🇸Los Angeles, California, United States
University of California Irvine
🇺🇸Irvine, California, United States
Rush-Presbyterian-St. Luke's Medical Center
🇺🇸Chicago, Illinois, United States
Cleveland Clinic Florida
🇺🇸Weston, Florida, United States
Johns Hopkins University, Department of Neurology
🇺🇸Baltimore, Maryland, United States
University of Kansas Medical Center/Dept. of Neurology
🇺🇸Kansas City, Kansas, United States
University of Tennessee Memphis, Semmes Murphy Clinic
🇺🇸Memphis, Tennessee, United States
Columbia Presbyterian Medical Center, Neurological Institute
🇺🇸New York, New York, United States
University of Sherbrooke
🇨🇦Fleurimont, Quebec, Canada
McGill Center for Studies in Aging
🇨🇦Verdun, Quebec, Canada
Stanford University Medical Center, Dept. of Neurology
🇺🇸Stanford, California, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
University of Connecticut Health Center
🇺🇸Farmington, Connecticut, United States
The Parkinson's Institute
🇺🇸Sunnyvale, California, United States
Northwestern University, Department of Neurology
🇺🇸Chicago, Illinois, United States
Medical College of Georgia
🇺🇸Augusta, Georgia, United States
University of Iowa Hospitals and Clinics, Department of Neurology
🇺🇸Iowa City, Iowa, United States
UMDNJ Robert Wood Johnson Medical Center
🇺🇸New Brunswick, New Jersey, United States
Clinical Neuroscience Center
🇺🇸Southfield, Michigan, United States
Washington University
🇺🇸St. Louis, Missouri, 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
Long Island Jewish Medical Center
🇺🇸New Hyde Park, New York, United States
University of Rochester, Department of Neurology
🇺🇸Rochester, New York, United States
Beth Israel Medical Center, Department of Neurology
🇺🇸New York, New York, United States
Medical College of Ohio, Department of Neurology
🇺🇸Toledo, Ohio, United States
Scott and White Clinic/Texas A & M University
🇺🇸Temple, Texas, United States
Brown University/Memorial Hospital of Rhode Island/Neurology Dept.
🇺🇸Pawtucket, Rhode Island, United States
University of Calgary
🇨🇦Calgary, Alberta, Canada
University of Virginia Health System/Adult Neurology
🇺🇸Charlottesville, Virginia, United States
Centre Hospitalier De L'Universite Montreal
🇨🇦Montreal, Quebec, Canada
Ottawa Hospital, Civic Site
🇨🇦Ottawa, Ontario, Canada
Saskatoon District Health Board - Royal University Hospital
🇨🇦Saskatoon, Saskatchewan, Canada
University of Puerto Rico, Clinical Research Center
🇵🇷San Juan, Puerto Rico
Barrow Neurological Institute
🇺🇸Phoenix, Arizona, United States
University of South Florida, Harbourside Medical Tower
🇺🇸Tampa, Florida, United States
University of Minnesota, Department of Neurology
🇺🇸Minneapolis, Minnesota, United States
Department of Neurology - UC Davis Medical Center
🇺🇸Sacramento, California, United States
University of California San Diego
🇺🇸San Diego, California, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Institute for Neurodegenerative Disorders
🇺🇸New Haven, Connecticut, United States
Indiana University of Medicine/Outpatient Clinical Research Facility
🇺🇸Indianapolis, Indiana, United States
University of Colorado Health Sciences Center
🇺🇸Denver, Colorado, United States
Creighton University/Department of Neurology
🇺🇸Omaha, Nebraska, United States
Oregon Health Sciences University/Dept. of Neurology
🇺🇸Portland, Oregon, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Medical College of Wisconsin, Department Neurology
🇺🇸Milwaukee, Wisconsin, United States