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

This study has been terminated.

Sponsors and Collaborators: Cephalon
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

Genetics Home Reference related topics:   Parkinson disease  

MedlinePlus related topics:   Parkinson's Disease  

U.S. FDA Resources

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

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

 Show 66 Study Locations

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

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.  This link exits the ClinicalTrials.gov site
 

Publications indexed to this study:

Study ID Numbers:   C1347c/204/PD/US-CA
First Received:   June 26, 2002
Last Updated:   November 9, 2007
ClinicalTrials.gov Identifier:   NCT00040404
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  

Study placed in the following topic categories:
Ganglion Cysts
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases
Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on July 03, 2008




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