Phase 3
Completed N=747
Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy
Source: ClinicalTrials.gov NCT00099268 ↗Enrolled (actual)
747
Serious AEs
23.5%
Results posted
Mar 2011
Primary outcomePrimary: Time to First Occurrence of Dyskinesia — 90.7; 117.1 weeks
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to First Occurrence of Dyskinesia |
90.7; 117.1 | — |
| SECONDARY Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score (Parts II and III) |
21.9; 21.8; 23.2; 22.8 | — |
| SECONDARY Occurrence of Wearing-off |
139; 161 | — |
| SECONDARY Time to First Occurrence of Wearing-off |
131.7; 129.5 | — |
| SECONDARY Occurrence of Dyskinesia |
128; 103 | — |
| SECONDARY Change From Baseline in Health-related Quality of Life Assessed Using the 39-item Parkinson's Disease Questionnaire (PDQ-39) |
4.1; 1.8 | — |
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of idiopathic Parkinson's disease
- Diagnosis of Parkinson's disease for no more than 5 years
Exclusion Criteria
- History, signs, or symptoms of atypical or secondary parkinsonism
- Presence at baseline of drug-related wearing-off symptoms, dyskinesia or other motor complications
- Levodopa exposure of more than 30 days or anytime within 8 weeks prior to visit 1
Other inclusion/exclusion criteria applied to this study.
Data sourced from ClinicalTrials.gov (NCT00099268). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.