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COMT Polymorphism and Entacapone Efficacy

NCT ID: NCT00373087

Last Updated: 2010-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2009-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Parkinson's Disease

Keywords

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Parkinson's disease Catechol O-methyltransferase Entacapone pharmacogenetic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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L-dopa + entacapone

L-dopa + entacapone

Group Type ACTIVE_COMPARATOR

entacapone

Intervention Type DRUG

entacapone

L dopa / placebo

L dopa / placebo

Group Type EXPERIMENTAL

l dopa versus placebo

Intervention Type DRUG

l dopa versus placebo

Interventions

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entacapone

entacapone

Intervention Type DRUG

l dopa versus placebo

l dopa versus placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Parkinson's disease
* wearing off

Exclusion Criteria

* atypical parkinsonism
* neuroleptic use
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Department Clinical Research of Developpement

Principal Investigators

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Jean Christophe CORVOL, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Centre d'Investigation Clinique, Hôpital de la Pitié-Salpétrière,

Paris, , France

Site Status

Countries

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France

Other Identifiers

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P051034

Identifier Type: -

Identifier Source: org_study_id