COMT Polymorphism and Entacapone Efficacy

• Sponsor: Assistance Publique - Hôpitaux de Paris (Other)
• Overall Status: Completed
• CT.gov ID: NCT00373087
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 37
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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: Oct 1, 2006
• Actual Primary Completion Date: Nov 1, 2009
• Actual Study Completion Date: Nov 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. L-dopa efficacy duration on UPDRS motor scale during an acute L-dopa test [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 [at the end of the study during the last hospitalization]

   Pharmacokinetics of L-dopa and its metabolites

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years and Older
• 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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00373087
• Other Study ID Numbers: P051034
• First Posted: Sep 7, 2006
• Last Update Posted: Apr 29, 2010
• Last Verified: Jul 1, 2007

• Keywords provided by , ,: Parkinson's disease; Catechol O-methyltransferase; Entacapone; pharmacogenetic
• Additional relevant MeSH terms: Parkinson Disease; Entacapone

Study Results

No Results Posted as of Apr 29, 2010