Conditions: Parkinson's Disease
Keywords: Idiopathic Parkinson's disease carbidopa/levodopa/entacapone non-motor symptoms motor-symptoms
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 14
Healthy volunteers: no

Brief summary:
The purpose of this study is to test the effects of carbidopa/levodopa/entacapone compared to the effects of immediate-release carbidopa/levodopa on non-motor symptoms of end-of-dose wearing off in persons who have Parkinson's disease.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Carbidopa/levodopa/entacapone intervention 2: Immediate release carbidopa/levodopa
Intervention descriptions: intervention 1: Carbidopa/levodopa/entacapone 25/100/200 mg tablets plus placebo immediate release carbidopa/levodopa capsules, administered orally for 8 weeks. Total daily dosage and frequency of dosing for each patient was determined by the investigator and stabilized upon entry into the study. intervention 2: Immediate release carbidopa/levodopa 25/100 mg capsules plus placebo carbidopa/levodopa/entacapone tablets, administered orally for 8 weeks. The maximum daily dose is 800 mg. Total daily dosage and frequency of dosing for each patient was determined by the investigator.

Protocol document: