NCT01568073

Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With "Wearing-off" Phenomenon

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: All
• Age: 30 Years – 83 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	BIA 9-1067	5, 25 and 50 mg of BIA 9-1067 (once-daily)
DRUG	Entacapone	200 mg entacapone (concomitantly with each L-dopa/DDCI dose)
DRUG	Placebo	200 mg
DRUG	Levodopa
DRUG	Carbidopa	DOPA decarboxylase inhibitor
DRUG	Benserazide	DOPA decarboxylase inhibitor

Timeline

• Start date: 2011-03-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2012-04-02
• Last updated: 2015-09-18
• Results posted: 2015-01-08

Locations

1 site across 1 country: Portugal