Conditions: Parkinson's Disease
Keywords: Parkinson's disease, levodopa therapy, dyskinesia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 747
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks. arm 2: Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.

Interventions: intervention 1: Carbidopa/levodopa/entacapone intervention 2: Immediate release carbidopa/levodopa
Intervention descriptions: intervention 1: Carbidopa/Levodopa/Entacapone 12.5/50/200 mg and 25/100/200 mg capsules. intervention 2: Immediate release carbidopa/levodopa 12.5/50 mg and 25/100 mg capsules.

Protocol document: