Conditions: Parkinson's Disease
Keywords: Parkinson PD Wearing-off Levodopa/DDCI
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 427
Healthy volunteers: no

Brief summary:
Parkinson's disease (PD) is a neurodegenerative disorder of unknown aetiology with an estimated incidence of 4.5-16/100,000 persons/year.

BIA 9-1067 is currently being developed by BIAL (Portela \& Cª,S.A.) to be used in addition to L-DOPA (Levodopa) /carbidopa or L-DOPA (Levodopa) / preparations in PD patients. Promising results have been obtained for BIA 9-1067 in previous studies.

Detailed description:
This study aims to demonstrate the efficacy and safety of BIA 9-1067 used in addition to L-DOPA/DDCI to control the "wearing-off" phenomenon in patients with PD.

DDCI (DOPA decarboxylase inhibitors): benserazide and carbidopa

Arms:
arm 1: BIA 9-1067, OPC, Opicapone 25 mg once daily (QD). arm 2: BIA 9-1067, OPC, Opicapone 50 mg once daily (QD). arm 3: PLC, Placebo

Interventions: intervention 1: BIA 9-1067 intervention 2: Placebo intervention 3: Levodopa intervention 4: Carbidopa intervention 5: Benserazide
Intervention descriptions: intervention 1: Capsules will be used. intervention 2: comparator intervention 3: None intervention 4: DOPA decarboxylase inhibitor (DDCI) intervention 5: DOPA decarboxylase inhibitor

Protocol document: