ClinicalTrials.gov
ClinicalTrials.gov Menu

COMT Polymorphism and Entacapone Efficacy (COMT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00373087
Recruitment Status : Completed
First Posted : September 7, 2006
Last Update Posted : April 29, 2010
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris

Brief Summary:
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 or disease Intervention/treatment Phase
Parkinson's Disease Drug: entacapone Drug: l dopa versus placebo Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Influence of Catechol-O-methyltransferase Polymorphism on Entacapone Efficacy in Parkinson's Disease
Study Start Date : October 2006
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: L-dopa + entacapone
L-dopa + entacapone
Drug: entacapone
entacapone
Experimental: L dopa / placebo
L dopa / placebo
Drug: l dopa versus placebo
l dopa versus placebo



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Parkinson's disease
  • wearing off

Exclusion Criteria:

  • atypical parkinsonism
  • neuroleptic use

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00373087


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

Responsible Party: Christophe Aucan, Department Clinical Research of Developpement
ClinicalTrials.gov Identifier: NCT00373087     History of Changes
Other Study ID Numbers: P051034
First Posted: September 7, 2006    Key Record Dates
Last Update Posted: April 29, 2010
Last Verified: July 2007

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

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Entacapone
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Catechol O-Methyltransferase Inhibitors
Enzyme Inhibitors