NCT01568034

A Study to Investigate the Tolerability and Effect of Three Single-dose Regimens of BIA 9-1067

A Double-blind, Randomised, Placebo-controlled, Cross-over Study to Investigate the Tolerability and Effect of Three Single-dose Regimens of BIA 9-1067 on the Levodopa Pharmacokinetics, Motor Response, and Erythrocyte Soluble Catechol-O-methyltransferase Activity in Parkinson's Disease Patients Concomitantly Treated With Levodopa/Dopa-decarboxylase Inhibitor

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the effect of BIA 9-1067 on the levodopa pharmacokinetics when administered in combination with immediate release levodopa/carbidopa or levodopa/benserazide in Parkinson's Disease (PD) patients.

Detailed description

This was a three-centre, double-blind, randomised, placebo-controlled, crossover study with four consecutive single-dose treatment periods in PD patients treated with immediate release 100 mg/25 mg levodopa/carbidopa or 100 mg/25 mg levodopa/benserazide

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	BIA 9-1067	BIA 9-1067 - 25 mg single-dose
DRUG	BIA 9-1067	BIA 9-1067 - 50 mg single-dose
DRUG	BIA 9-1067	BIA 9-1067 - 100 mg single-dose
DRUG	Placebo	single-dose
DRUG	Levodopa/Carbidopa	Levodopa 100 mg Carbidopa 25 mg
DRUG	Levodopa/Benzerazide	Levodopa 100 mg Benzerazide 25 mg

Timeline

• Start date: 2009-04-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2012-04-02
• Last updated: 2015-01-12
• Results posted: 2015-01-12

Locations

3 sites across 3 countries: Portugal, Romania, Ukraine