Phase 4
Completed N=359
Effects of Carbidopa/Levodopa/Entacapone on Motor Function and Quality of Life in Patients With Parkinson's Disease
Parkinson's Disease With End of Dose Wearing Off
Source: ClinicalTrials.gov NCT00219284 ↗
Enrolled (actual)
359
Serious AEs
5.6%
Results posted
Mar 2011
Primary outcomePrimary: Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score From Baseline to Week 4 — -3.7; -1.8 Units on a scale
Summary
To assess motor function and quality of life (QoL) in Parkinson's disease (PD) subjects with end-of-dose wearing off, comparing immediate and delayed switch to carbidopa/levodopa and entacapone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score From Baseline to Week 4 |
-3.7; -1.8 | — |
| SECONDARY Change in Parkinson's Disease Quality of Life Score From Baseline to Week 4 |
-0.4; 1.1 | — |
| SECONDARY Change in Parkinson's Disease Quality of Life Score From Baseline to Week 8 |
-2.5; -1.1 | — |
| SECONDARY Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score From Baseline to Week 8 |
-3.6; -3.7 | — |
| SECONDARY Change in the 39-item Parkinson's Disease Questionnaire (PDQ-39) Total Score From Baseline to Week 4 |
-1.7; 0.8 | — |
| SECONDARY Change in the 39-item Parkinson's Disease Questionnaire (PDQ-39) Total Score From Baseline to Week 8 |
-5.8; -1.9 | — |
| SECONDARY Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score From Baseline to End of Treatment |
-3.6; -3.3 | — |
| SECONDARY Change in Parkinson's Disease Quality of Life Score From Baseline to End of Treatment |
-1.3; 0.2 | — |
| SECONDARY Change in the 39-item Parkinson's Disease Questionnaire (PDQ-39) Total Score From Baseline to End of Treatment |
-2.8; 0.4 | — |
Eligibility Criteria
Inclusion Criteria
- Males or females 30-80 years of age (inclusive). Patients aged 81-85 years were eligible to participate if the principal investigator considered the patient to be in otherwise good health.
- Clinical diagnosis of Parkinson's disease exhibiting two of three symptoms (rigidity, resting tremor, bradykinesia).
- All patients were required to have end-of dose wearing off (EODWO, re-emergence of PD symptoms at the end of at least two daily doses of levodopa during waking hours).
- Taking regular doses of immediate release carbidopa/levodopa
Exclusion Criteria
- Unstable Parkinson's Disease requiring booster doses or treatment with as needed dose regimens of levodopa
- Female subjects who are pregnant, trying to become pregnant or nursing an infant
Other protocol-defined inclusion/exclusion criteria applied to this study.
Data sourced from ClinicalTrials.gov (NCT00219284). 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.