CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 747 enrolled
Drug / intervention
Carbidopa/levodopa/entacapone +1 moredrug
Likely dose
Carbidopa/Levodopa/Entacapone 12.5/50/200 mg and 25/100/200 mg capsulesAI-extracted
Key inclusion· 2
  • ✓Clinical diagnosis of idiopathic Parkinson's disease
  • ✓Parkinson's disease diagnosis for no more than 5 years
Key exclusion· 3
  • ✕History, signs, or symptoms of atypical or secondary parkinsonism
  • ✕Presence of drug-related wearing-off symptoms, dyskinesia, or other motor complications at baseline
  • ✕Levodopa exposure exceeding 30 days total or any use within 8 weeks prior to visit 1

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00099268
NCT00099268Phase 3Completed
CompareCT.gov

A Long Term, Double-blind, Randomized, Parallel-group, Carbidopa/Levodopa Controlled, Multi-center Study to Evaluate the Effect of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy

Novartis Pharmaceuticals·interventional·Posted Dec 10, 2004·Updated Apr 23, 2012

In Brief

A Phase 3 clinical trial evaluating Carbidopa/levodopa/entacapone and Immediate release carbidopa/levodopa for Parkinson's Disease. Completed, enrolled 747 participants across 73 sites in 14 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson's Disease
CountriesAustria, Belgium, Canada, Finland, France, Germany, Greece, Italy, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom, United States
CollaboratorsOrion Corporation, Orion Pharma

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 10, 2004
Enrollment StartSep 1, 2004
Primary CompletionNov 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 21.6 years ago

Interventions

Carbidopa/levodopa/entacaponedrug

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

Immediate release carbidopa/levodopadrug

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