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Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy

NCT00099268 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 747

Last updated 2012-04-23

Study results available
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Summary

The CELC200A2401 study has been designed in order to evaluate the hypothesis that administering the combination carbidopa/levodopa/entacapone at the time that levodopa therapy is initiated results in a decrease in the risk of the development of motor complications for patients with Parkinson's disease.

Conditions

Interventions

DRUG

Carbidopa/levodopa/entacapone

Carbidopa/Levodopa/Entacapone 12.5/50/200 mg and 25/100/200 mg capsules.

DRUG

Immediate release carbidopa/levodopa

Immediate release carbidopa/levodopa 12.5/50 mg and 25/100 mg capsules.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2008-11-30
Completion
2008-11-30

Countries

  • United States
  • Austria
  • Belgium
  • Canada
  • Finland
  • France
  • Germany
  • Greece
  • Italy
  • Spain
  • Sweden
  • Switzerland
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00099268 on ClinicalTrials.gov