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COMT Polymorphism and Entacapone Efficacy

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00373087
First received: September 6, 2006
Last updated: April 28, 2010
Last verified: July 2007
History of Changes
  Purpose

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:

U.S. FDA Resources

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
entacapone
Other Name: entacapone
Experimental: L dopa / placebo
L dopa / placebo
 Drug: l dopa versus placebo
l dopa versus placebo
Other Name: 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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Parkinson's disease
  • wearing off

Exclusion Criteria:

  • atypical parkinsonism
  • neuroleptic use
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Christophe Aucan, Department Clinical Research of Developpement
ClinicalTrials.gov 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
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
Dihydroxyphenylalanine
Levodopa
Entacapone
 Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on June 18, 2013