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COMT Polymorphism and Entacapone Efficacy

Information source: Assistance Publique - H˘pitaux de Paris
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Parkinson's Disease

Intervention: entacapone (Drug); l dopa versus placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Assistance Publique - H˘pitaux de Paris

Official(s) and/or principal investigator(s):
Jean Christophe CORVOL, MD,PhD, Principal Investigator, Affiliation: Assistance Publique - H├┤pitaux de Paris

Summary

Entacapone is an antiparkinsonian drug which block L-dopa metabolism, inhibiting the C-O-methyltransferase (COMT) enzyme. There is an individual variability of the COMT activity determined by a genetic polymorphism. The aim of this study is to investigate whether the genetic variability influences entacapone efficacy in Parkinson's disease.

Clinical Details

Official title: Influence of Catechol-O-methyltransferase Polymorphism on Entacapone Efficacy in Parkinson's Disease

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: L-dopa efficacy duration on UPDRS motor scale during an acute L-dopa test

Secondary outcome: Pharmacokinetics of L-dopa and its metabolites

Detailed description: COMT protein is dependent of a single autosomal locus with two co-dominant alleles with a high activity (allele H) and a low activity (allele L) form of the enzyme. L and H allele frequency in the Caucasian population is around 50%. This is a monocentric randomized blinded cross-over study comparing acute challenge of L-dopa + placebo versus L-dopa + 200 mg entacapone, in Parkinson's disease patients with HH and LL genotypes.

Eligibility

Minimum age: 30 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Parkinson's disease

- wearing off

Exclusion Criteria:

- atypical parkinsonism

- neuroleptic use

Locations and Contacts

Centre d'Investigation Clinique, H├┤pital de la Piti├ę-Salp├ętri├Ęre,, Paris 75013, France
Additional Information

Starting date: October 2006
Last updated: April 28, 2010

Page last updated: August 20, 2015

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