COMT Polymorphism and Entacapone Efficacy
- Conditions
- Parkinson's Disease
- Interventions
- Registration Number
- NCT00373087
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Parkinson's disease
- wearing off
- atypical parkinsonism
- neuroleptic use
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description L-dopa + entacapone entacapone L-dopa + entacapone L dopa / placebo l dopa versus placebo L dopa / placebo
- Primary Outcome Measures
Name Time Method 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
Name Time Method Pharmacokinetics of L-dopa and its metabolites at the end of the study during the last hospitalization Pharmacokinetics of L-dopa and its metabolites
Trial Locations
- Locations (1)
Centre d'Investigation Clinique, Hôpital de la Pitié-Salpétrière,
🇫🇷Paris, France