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
About this trial
This is an interventional treatment trial for Parkinson's Disease With End of Dose Wearing Off focused on measuring Parkinson's disease, tremor
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Immediate switch
Delayed switch
Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.