Conditions: Parkinson's Disease
Keywords: Parkinson Disease BIA 9-1067
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 40
Healthy volunteers: no

Brief summary:
The purpose of this study is to investigate the tolerability and the effect of BIA 9-1067 at steady-state on the levodopa pharmacokinetics in Parkinson's Disease (PD) patients treated with levodopa/dopa-decarboxylase inhibitor.

Detailed description:
Multicentre, double-blind, randomised, placebo-controlled study in four parallel groups of PD patients treated with standard-release levodopa/carbidopa 100/25 mg (Sinemet®) or levodopa/benserazide 100/25 mg (Madopar®/Restex®) and with motor fluctuations ("wearing-off" phenomenon)

Arms:
arm 1: PLC, Placebo

Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half arm 2: 5 mg BIA 9-1067 (OPC, Opicapone)

Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half arm 3: 15 mg BIA 9-1067 (OPC, Opicapone)

Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half arm 4: 30 mg BIA 9-1067 (OPC, Opicapone)

Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half

Interventions: intervention 1: Placebo intervention 2: BIA 9-1067 intervention 3: BIA 9-1067 intervention 4: BIA 9-1067 intervention 5: Levodopa/Carbidopa intervention 6: Levodopa/Benzerazide
Intervention descriptions: intervention 1: once-daily intervention 2: BIA 9-1067 - 5 mg single-dose intervention 3: BIA 9-1067 - 15 mg single-dose intervention 4: BIA 9-1067 - 30 mg single-dose intervention 5: Levodopa 100 mg Carbidopa 25 mg intervention 6: Levodopa 100 mg Benzerazide 25 mg

Protocol document: