Conditions: Parkinson's Disease
Keywords: Parkinson PD Wearing-off Levodopa/DDCI
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 600
Healthy volunteers: no

Brief summary:
This study aims to demonstrate the efficacy and safety of BIA 9-1067, compared with entacapone or placebo, when administered with the existing treatment of L-DOPA plus a Dopa Decarboxylase Inhibitor (DDCI), in patients with Parkinson's Disease (PD) and end-of-dose motor fluctuations.

Detailed description:
Efficacy and safety of BIA 9-1067 in idiopathic Parkinson's disease patients with "wearing-off" phenomenon treated with levodopa plus a dopa decarboxylase inhibitor (DDCI): a double-blind, randomised, placebo- and active-controlled, parallel-group, multicentre clinical study.

Arms:
arm 1: OPC, Opicapone arm 2: Comtan®; Active comparator arm 3: PLC, Placebo

Interventions: intervention 1: BIA 9-1067 intervention 2: Entacapone intervention 3: Placebo intervention 4: Levodopa intervention 5: Carbidopa intervention 6: Benserazide
Intervention descriptions: intervention 1: 5, 25 and 50 mg of BIA 9-1067 (once-daily) intervention 2: 200 mg entacapone (concomitantly with each L-dopa/DDCI dose) intervention 3: 200 mg intervention 4: None intervention 5: DOPA decarboxylase inhibitor intervention 6: DOPA decarboxylase inhibitor

Protocol document: