Document Detail


DATATOP: a multicenter controlled clinical trial in early Parkinson's disease. Parkinson Study Group.
MedLine Citation:
PMID:  2508608     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
DATATOP (Deprenyl and tocopherol antioxidative therapy of parkinsonism) is a placebo-controlled clinical trial designed to test the hypothesis that long-term treatment of patients with early Parkinson's disease with deprenyl 10 mg/d and/or tocopherol (vitamin E) 2000 IU/d will extend the time until disability requires therapy with levodopa (primary end point). At 28 US and Canadian sites, 800 eligible patients in the early stages of untreated Parkinson's disease were enrolled in DATATOP and randomized to (1) active deprenyl, (2) active tocopherol, (3) active deprenyl and tocopherol, or (4) placebo treatments. Subjects are being evaluated systematically at regular intervals over 2 years to determine if and when the primary end point of disability is attained. At baseline evaluation, our cohort represented minimally disabled patients with Parkinson's disease who did not require symptomatic anti-Parkinson's disease medications. Despite an almost 2:1 representation of male-female subjects, no selection biases were identified that might confound the primary end-point analysis. This large DATATOP cohort is expected to provide a high likelihood (power) for detecting significant treatment effects, if indeed they exist.
Authors:
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  Archives of neurology     Volume:  46     ISSN:  0003-9942     ISO Abbreviation:  Arch. Neurol.     Publication Date:  1989 Oct 
Date Detail:
Created Date:  1989-11-09     Completed Date:  1989-11-09     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  0372436     Medline TA:  Arch Neurol     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  1052-60     Citation Subset:  AIM; IM    
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MeSH Terms
Descriptor/Qualifier:
Cohort Studies
Double-Blind Method
Drug Therapy, Combination
Female
Humans
Male
Middle Aged
Multicenter Studies as Topic
Parkinson Disease / drug therapy*
Phenethylamines / therapeutic use*
Randomized Controlled Trials as Topic
Selegiline / therapeutic use*
Vitamin E / therapeutic use*
Grant Support
ID/Acronym/Agency:
NS24778/NS/NINDS NIH HHS; RR00645/RR/NCRR NIH HHS; RR00847/RR/NCRR NIH HHS
Chemical
Reg. No./Substance:
0/Phenethylamines; 1406-18-4/Vitamin E; 14611-51-9/Selegiline

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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