Document Detail

Pramipexole in patients with early Parkinson's disease.
MedLine Citation:
PMID:  8665547     Owner:  NLM     Status:  MEDLINE    
We evaluated the efficacy, safety, tolerability, and pharmacokinetics of pramipexole, a novel dopamine D2 receptor agonist, in early Parkinson's disease (PD). The study design was a parallel, placebo-controlled trial using an ascending dose of 4.5 mg/day pramipexole maximum. All subjects received selegiline (10 mg/day) but were not treated with levodopa. Of the 55 subjects who received at least one dose of the study medication, all but one, in the placebo group, completed the trial, which was 9 weeks in duration. The primary efficacy endpoints were changes in scores from baseline to final measurement on the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II and III. The pramipexole group had a significantly greater improvement (p = 0.002) than the placebo group on UPDRS Part II (Activities of Daily Living). The change in score from baseline to final measurement on UPDRS Part III (Motor Examination) was not significantly different (p = 0.10) between the pramipexole and placebo groups, although the trend favoured the pramipexole group. All subjects in both the pramipexole and the placebo groups experienced one or more episodes of asymptomatic orthostatic hypotension; there was no significant difference between the pramipexole and the placebo groups in the number of subjects experiencing symptomatic orthostatic hypotension. The adverse events profile of pramipexole was similar, in general, to that of other dopamine receptor agonists. Plasma pramipexole levels increased linearly with dose. Pramipexole appears to be promising agent in the treatment of early PD.
J P Hubble; W C Koller; N R Cutler; J J Sramek; J Friedman; C Goetz; A Ranhosky; D Korts; A Elvin
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Clinical neuropharmacology     Volume:  18     ISSN:  0362-5664     ISO Abbreviation:  Clin Neuropharmacol     Publication Date:  1995 Aug 
Date Detail:
Created Date:  1996-08-07     Completed Date:  1996-08-07     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  7607910     Medline TA:  Clin Neuropharmacol     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  338-47     Citation Subset:  IM    
Department of Neurology, University of Kansas Medical Center, Kansas City 66160-7314, USA.
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MeSH Terms
Dopamine Agonists / pharmacokinetics,  therapeutic use*
Parkinson Disease / drug therapy*
Thiazoles / therapeutic use*
Time Factors
Reg. No./Substance:
0/Benzothiazoles; 0/Dopamine Agonists; 0/Thiazoles; 104632-26-0/pramipexol

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

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