Parkinson's Disease
Conditions
Keywords
Parkinson's disease, Catechol O-methyltransferase, Entacapone, pharmacogenetic
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.
Interventions
DRUGentacapone
entacapone
DRUGl dopa versus placebo
l dopa versus placebo
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Parkinson's disease * wearing off
Exclusion criteria
* atypical parkinsonism * neuroleptic use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics of L-dopa and its metabolites | at the end of the study during the last hospitalization | Pharmacokinetics of L-dopa and its metabolites |
Countries
France
Outcome results
None listed