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Completed

NCT Number: NCT00373087

COMT Polymorphism and Entacapone Efficacy

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Paris, 75013, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Parkinson's disease
  • wearing off

Exclusion criteria

  • atypical parkinsonism
  • neuroleptic use

Treatment and study plan

Entacapone

Drug

entacapone

l dopa versus placebo

Drug

l dopa versus placebo

Primary outcomes

  1. L-dopa efficacy duration on UPDRS motor scale during an acute L-dopa test

    Time frame: during the hospitalization in 24 hours

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

Secondary outcomes

  1. Pharmacokinetics of L-dopa and its metabolites

    Time frame: at the end of the study during the last hospitalization

    Pharmacokinetics of L-dopa and its metabolites

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: COMT

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Sep 7, 2006
Registry last updated
Apr 29, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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