At a glance
ClinicalIndex Comparison Record- ✓Age 30–80 years (31–85 with investigator discretion)
- ✓Clinical diagnosis of Parkinson's disease with at least 2 of 3 cardinal symptoms: rigidity, resting tremor, or bradykinesia
- ✓End-of-dose wearing off: re-emergence of PD symptoms at the end of at least two daily doses of levodopa during waking hours
- ✓Currently taking regular doses of immediate-release carbidopa/levodopa
- ✕Unstable Parkinson's disease requiring booster doses or as-needed levodopa regimens
- ✕Pregnant, attempting to become pregnant, or nursing
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Multi-center, Randomized, Open-label Study With Blinded Raters to Evaluate the Effects of Immediate Versus Delayed Switch to Carbidopa/Levodopa/Entacapone on Motor Function and Quality of Life in Patients With Parkinson's Disease With End-of-dose Wearing Off
In Brief
A Phase 4 clinical trial evaluating Carbidopa/levodopa/entacapone for Parkinson's Disease With End of Dose Wearing Off. Completed, enrolled 359 participants across 42 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone.