COMT Polymorphism and Entacapone Efficacy (COMT)
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
entacapone
l dopa versus placebo
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, Catechol O-methyltransferase, Entacapone, pharmacogenetic
Eligibility Criteria
Inclusion Criteria:
- Parkinson's disease
- wearing off
Exclusion Criteria:
- atypical parkinsonism
- neuroleptic use
Sites / Locations
- Centre d'Investigation Clinique, Hôpital de la Pitié-Salpétrière,
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
L-dopa + entacapone
L dopa / placebo
Arm Description
L-dopa + entacapone
L dopa / placebo
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Pharmacokinetics of L-dopa and its metabolites
Pharmacokinetics of L-dopa and its metabolites
Full Information
NCT ID
NCT00373087
First Posted
September 6, 2006
Last Updated
April 28, 2010
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT00373087
Brief Title
COMT Polymorphism and Entacapone Efficacy
Acronym
COMT
Official Title
Influence of Catechol-O-methyltransferase Polymorphism on Entacapone Efficacy in Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2007
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, Catechol O-methyltransferase, Entacapone, pharmacogenetic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
L-dopa + entacapone
Arm Type
Active Comparator
Arm Description
L-dopa + entacapone
Arm Title
L dopa / placebo
Arm Type
Experimental
Arm Description
L dopa / placebo
Intervention Type
Drug
Intervention Name(s)
entacapone
Intervention Description
entacapone
Intervention Type
Drug
Intervention Name(s)
l dopa versus placebo
Intervention Description
l dopa versus placebo
Primary Outcome Measure Information:
Title
L-dopa efficacy duration on UPDRS motor scale during an acute L-dopa test
Description
L-dopa efficacy duration on UPDRS motor scale during an acute L-dopa test
Time Frame
during the hospitalization in 24 hours
Secondary Outcome Measure Information:
Title
Pharmacokinetics of L-dopa and its metabolites
Description
Pharmacokinetics of L-dopa and its metabolites
Time Frame
at the end of the study during the last hospitalization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Parkinson's disease
wearing off
Exclusion Criteria:
atypical parkinsonism
neuroleptic use
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Christophe CORVOL, MD,PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre d'Investigation Clinique, Hôpital de la Pitié-Salpétrière,
City
Paris
ZIP/Postal Code
75013
Country
France
12. IPD Sharing Statement
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COMT Polymorphism and Entacapone Efficacy
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