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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Parkinson's disease
  • wearing off

Exclusion Criteria:

  • atypical parkinsonism
  • neuroleptic use
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Health Authority: France: Ministry of Health

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

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Anti-Dyskinesia Agents
Antiparkinson Agents
Central Nervous System Agents
Dopamine Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on April 27, 2016