NCT01568047

Multicentre Study in Four Parallel Groups of Parkinson's Disease (PD) Patients

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Placebo	once-daily
DRUG	BIA 9-1067	BIA 9-1067 - 5 mg single-dose
DRUG	BIA 9-1067	BIA 9-1067 - 15 mg single-dose
DRUG	BIA 9-1067	BIA 9-1067 - 30 mg single-dose
DRUG	Levodopa/Carbidopa	Levodopa 100 mg Carbidopa 25 mg
DRUG	Levodopa/Benzerazide	Levodopa 100 mg Benzerazide 25 mg

Timeline

• Start date: 2010-02-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2012-04-02
• Last updated: 2015-12-24
• Results posted: 2015-01-08

Locations

7 sites across 2 countries: Romania, Ukraine