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A randomized controlled trial comparing pramipexole with levodopa in early Parkinson's disease: design and methods of the CALM-PD Study. Parkinson Study Group.
Clin Neuropharmacol. 2000 Jan-Feb; 23(1):34-44.CN

Abstract

CALM-PD (Comparison of the agonist pramipexole with levodopa on motor complications of Parkinson's disease) is a randomized, multicenter, double-blind, controlled clinical trial designed to compare the policy of initial treatment of pramipexole with the policy of initial treatment with levodopa in early, symptomatic Parkinson's disease with regard to the development of dopaminergic motor complications. At 22 American and Canadian sites, 301 eligible subjects requiring antiparkinsonian therapy to treat emerging disability were enrolled in CALM-PD and randomized to (i) active pramipexole and placebo levodopa or (ii) placebo pramipexole and active levodopa. Subjects are being evaluated systematically at regular intervals during a 23.5-month period to determine if and when dopaminergic motor complications (wearing off, dyskinesias, "on-off" effects) occur. In addition, quality-of-life outcomes, economic outcomes, and functional imaging outcomes are being assessed in standard fashion with [123I] beta-CIT and SPECT imaging throughout the trial. The study design contains many provisions to approximate routine clinical practice and to produce data about clinical effectiveness, tolerability, and cost to facilitate the evidence-based practice of neurology.

Pub Type(s)

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.

Language

eng

PubMed ID

10682229

Citation

"A Randomized Controlled Trial Comparing Pramipexole With Levodopa in Early Parkinson's Disease: Design and Methods of the CALM-PD Study. Parkinson Study Group." Clinical Neuropharmacology, vol. 23, no. 1, 2000, pp. 34-44.
A randomized controlled trial comparing pramipexole with levodopa in early Parkinson's disease: design and methods of the CALM-PD Study. Parkinson Study Group. Clin Neuropharmacol. 2000;23(1):34-44.
(2000). A randomized controlled trial comparing pramipexole with levodopa in early Parkinson's disease: design and methods of the CALM-PD Study. Parkinson Study Group. Clinical Neuropharmacology, 23(1), 34-44.
A Randomized Controlled Trial Comparing Pramipexole With Levodopa in Early Parkinson's Disease: Design and Methods of the CALM-PD Study. Parkinson Study Group. Clin Neuropharmacol. 2000 Jan-Feb;23(1):34-44. PubMed PMID: 10682229.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized controlled trial comparing pramipexole with levodopa in early Parkinson's disease: design and methods of the CALM-PD Study. Parkinson Study Group. PY - 2000/2/22/pubmed PY - 2000/3/25/medline PY - 2000/2/22/entrez SP - 34 EP - 44 JF - Clinical neuropharmacology JO - Clin Neuropharmacol VL - 23 IS - 1 N2 - CALM-PD (Comparison of the agonist pramipexole with levodopa on motor complications of Parkinson's disease) is a randomized, multicenter, double-blind, controlled clinical trial designed to compare the policy of initial treatment of pramipexole with the policy of initial treatment with levodopa in early, symptomatic Parkinson's disease with regard to the development of dopaminergic motor complications. At 22 American and Canadian sites, 301 eligible subjects requiring antiparkinsonian therapy to treat emerging disability were enrolled in CALM-PD and randomized to (i) active pramipexole and placebo levodopa or (ii) placebo pramipexole and active levodopa. Subjects are being evaluated systematically at regular intervals during a 23.5-month period to determine if and when dopaminergic motor complications (wearing off, dyskinesias, "on-off" effects) occur. In addition, quality-of-life outcomes, economic outcomes, and functional imaging outcomes are being assessed in standard fashion with [123I] beta-CIT and SPECT imaging throughout the trial. The study design contains many provisions to approximate routine clinical practice and to produce data about clinical effectiveness, tolerability, and cost to facilitate the evidence-based practice of neurology. SN - 0362-5664 UR - https://www.unboundmedicine.com/medline/citation/10682229/A_randomized_controlled_trial_comparing_pramipexole_with_levodopa_in_early_Parkinson's_disease:_design_and_methods_of_the_CALM_PD_Study__Parkinson_Study_Group_ L2 - https://doi.org/10.1097/00002826-200001000-00007 DB - PRIME DP - Unbound Medicine ER -