NCT01227655

Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients.

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-controlled, Parallel-group, Multicentre Clinical Study.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 427 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: All
• Age: 30 Years – 83 Years
• Healthy volunteers: Not accepted

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

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	BIA 9-1067	Capsules will be used.
DRUG	Placebo	comparator
DRUG	Levodopa
DRUG	Carbidopa	DOPA decarboxylase inhibitor (DDCI)
DRUG	Benserazide	DOPA decarboxylase inhibitor

Timeline

• Start date: 2011-03-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2010-10-25
• Last updated: 2015-10-19
• Results posted: 2015-01-13

Locations

1 site across 1 country: Portugal