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Safety and Efficacy Study of CEP-1347 in the Treatment of Parkinson's Disease | Clinical Trials | Clareo Health

TERMINATEDPHASE2/PHASE3

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

A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Efficacy and Safety of CEP-1347 in Patients With Parkinson's Disease

NCT00040404•Cephalon

View on ClinicalTrials.gov

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.

Eligibility

Age

30 - No limit years

Sex

ALL

Healthy Volunteers

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)
+11 more criteria

Locations (66)

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

Key Dates

Start Date

March 1, 2002

Primary Completion Date

August 1, 2005

Completion Date

August 1, 2005

Last Updated

May 10, 2012

Enrollment

806

ACTUAL participants

Conditions

Parkinson Disease

Interventions

CEP-1347 10mg

DRUG

CEP1347 25mg

DRUG

CEP-1347 50mg

DRUG

Placebo Comparator

OTHER

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

NCT06692920

Parkinson Disease

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RECRUITINGPHASE1

[18F]F-DOPA Imaging in Patients With Autonomic Failure

NCT04246437

Autonomic FailurePure Autonomic Failure+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 10, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

[18F]F-DOPA Imaging in Patients With Autonomic Failure

Montelukast in Parkinson Disease

Exercise for Cognitive Excellence in Parkinson's Disease

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations

The Effect of Functional Rotational Exercises on Fall Risk and Mobility in Parkinson's Disease Patients