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COMT Polymorphism and Entacapone Efficacy (COMT)

This study has been completed.
Information provided by:
Assistance Publique - Hôpitaux de Paris Identifier:
First received: September 6, 2006
Last updated: April 28, 2010
Last verified: July 2007
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.

Condition Intervention Phase
Parkinson's Disease
Drug: entacapone
Drug: l dopa versus placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Influence of Catechol-O-methyltransferase Polymorphism on Entacapone Efficacy in Parkinson's Disease

Resource links provided by NLM:

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

Enrollment: 60
Study Start Date: October 2006
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: L-dopa + entacapone
L-dopa + entacapone
Drug: entacapone
Experimental: L dopa / placebo
L dopa / placebo
Drug: l dopa versus placebo
l dopa versus placebo

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.

Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Parkinson's disease
  • wearing off

Exclusion Criteria:

  • atypical parkinsonism
  • neuroleptic use
  Contacts and Locations
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Please refer to this study by its identifier: NCT00373087

Centre d'Investigation Clinique, Hôpital de la Pitié-Salpétrière,
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Principal Investigator: Jean Christophe CORVOL, MD,PhD Assistance Publique - Hôpitaux de Paris
  More Information

Responsible Party: Christophe Aucan, Department Clinical Research of Developpement Identifier: NCT00373087     History of Changes
Other Study ID Numbers: P051034
Study First Received: September 6, 2006
Last Updated: April 28, 2010

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Parkinson's disease
Catechol O-methyltransferase

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Antiparkinson Agents
Anti-Dyskinesia Agents
Catechol O-Methyltransferase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs processed this record on April 28, 2017