NCT00373087

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2006

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 7, 2006

Completed
24 days until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

April 29, 2010

Status Verified

July 1, 2007

Enrollment Period

3.1 years

First QC Date

September 6, 2006

Last Update Submit

April 28, 2010

Conditions

Parkinson's Disease

Keywords

Parkinson's diseaseCatechol O-methyltransferaseEntacaponepharmacogenetic

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Pharmacokinetics of L-dopa and its metabolites

    at the end of the study during the last hospitalization

Study Arms (2)

L-dopa + entacapone

ACTIVE COMPARATOR

L-dopa + entacapone

Drug: entacapone

L dopa / placebo

EXPERIMENTAL

L dopa / placebo

Drug: l dopa versus placebo

Interventions

entacaponeDRUG

entacapone

L-dopa + entacapone
l dopa versus placeboDRUG

l dopa versus placebo

L dopa / placebo

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parkinson's disease
  • wearing off

You may not qualify if:

  • atypical parkinsonism
  • neuroleptic use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'Investigation Clinique, Hôpital de la Pitié-Salpétrière,

Paris, 75013, France

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

entacapone

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Jean Christophe CORVOL, MD,PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2006

First Posted

September 7, 2006

Study Start

October 1, 2006

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

April 29, 2010

Record last verified: 2007-07

Locations

FR(1)