COMT Polymorphism and Entacapone Efficacy

Parkinson's Disease Clinical Trial

— COMT  

Official title:

Influence of Catechol-O-methyltransferase Polymorphism on Entacapone Efficacy in Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00373087
• Other study ID #: P051034
• Status: Completed
• Phase: Phase 4
• First received: September 6, 2006
• Last updated: April 28, 2010
• Start date: October 2006
• Est. completion date: November 2009

Study information

• Verified date: July 2007
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• Parkinson's disease

• wearing off

Exclusion Criteria:

• atypical parkinsonism

• neuroleptic use

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• entacapone
entacapone
• l dopa versus placebo
l dopa versus placebo

Locations

Country	Name	City	State
France	Centre d'Investigation Clinique, Hôpital de la Pitié-Salpétrière,	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	L-dopa efficacy duration on UPDRS motor scale during an acute L-dopa test	L-dopa efficacy duration on UPDRS motor scale during an acute L-dopa test	during the hospitalization in 24 hours	Yes
Secondary	Pharmacokinetics of L-dopa and its metabolites	Pharmacokinetics of L-dopa and its metabolites	at the end of the study during the last hospitalization	No