COMT Polymorphism and Entacapone Efficacy

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 4

Conditions: Parkinson's Disease

Treatments: Drug: entacapone; Drug: l dopa versus placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00373087

P051034

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Parkinson's disease
• wearing off

Exclusion criteria

• atypical parkinsonism
• neuroleptic use

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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60 participants in 2 patient groups

L-dopa + entacapone

Active Comparator group

Description:

L-dopa + entacapone

Treatment:

Drug: entacapone

L dopa / placebo

Experimental group

Description:

L dopa / placebo

Treatment:

Drug: l dopa versus placebo