- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00373087
COMT Polymorphism and Entacapone Efficacy (COMT)
April 28, 2010 updated by: Assistance Publique - Hôpitaux de Paris
Influence of Catechol-O-methyltransferase Polymorphism on Entacapone Efficacy in Parkinson's Disease
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Paris, France, 75013
- Centre d'Investigation Clinique, Hôpital de la Pitié-Salpétrière,
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Parkinson's disease
- wearing off
Exclusion Criteria:
- atypical parkinsonism
- neuroleptic use
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: L-dopa + entacapone
|
entacapone
|
Experimental: L dopa / placebo
|
l dopa versus placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
L-dopa efficacy duration on UPDRS motor scale during an acute L-dopa test
Time Frame: during the hospitalization in 24 hours
|
L-dopa efficacy duration on UPDRS motor scale during an acute L-dopa test
|
during the hospitalization in 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics of L-dopa and its metabolites
Time Frame: at the end of the study during the last hospitalization
|
Pharmacokinetics of L-dopa and its metabolites
|
at the end of the study during the last hospitalization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jean Christophe CORVOL, MD,PhD, Assistance Publique - Hôpitaux de Paris
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2006
Primary Completion (Actual)
November 1, 2009
Study Completion (Actual)
November 1, 2009
Study Registration Dates
First Submitted
September 6, 2006
First Submitted That Met QC Criteria
September 6, 2006
First Posted (Estimate)
September 7, 2006
Study Record Updates
Last Update Posted (Estimate)
April 29, 2010
Last Update Submitted That Met QC Criteria
April 28, 2010
Last Verified
July 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Parkinson Disease
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Catechol O-Methyltransferase Inhibitors
- Entacapone
Other Study ID Numbers
- P051034
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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