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

Tracking Information
First Received Date ^ICMJE	June 26, 2002
Last Updated Date	November 9, 2007
Start Date ^ICMJE	March 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00040404 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy Study of CEP-1347 in the Treatment of Parkinson's Disease
Official Title ^ICMJE	A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Efficacy and Safety of CEP-1347 in Patients With Parkinson's Disease
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
Study Phase	Phase II, Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Parkinson Disease
Intervention ^ICMJE	Drug: CEP-1347
Study Arms / Comparison Groups
Publications *	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. 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. Epub 2007 Sep 19.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	800
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	30 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Canada, Puerto Rico

Administrative Information
NCT ID ^ICMJE	NCT00040404
Responsible Party
Study ID Numbers ^ICMJE	C1347c/204/PD/US-CA
Study Sponsor ^ICMJE	Cephalon
Collaborators ^ICMJE	H. Lundbeck A/S The Parkinson Study Group
Investigators ^ICMJE
Information Provided By	Cephalon
Verification Date	November 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP