Safety and Efficacy Study of CEP-1347 in the Treatment of Parkinson's Disease

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Parkinson Disease

In brief

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.

Key facts

Study ID: NCT00040404
Run by: Cephalon
People needed: 806
Starts: 2002-03-01
Expected to finish: 2005-08-01
Last updated by the study team: 2012-05-10

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

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
Barrow Neurological Institute — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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