NCT02834507

Effect of Two Multiple-dose Regimens of BIA 3-202 on the Pharmacokinetics and Motor Response of Levodopa, and on the Erythrocyte Comt Activity in Parkinson's Disease Patients

A Double-blind, Randomised, Placebo- and Active-controlled, Cross-over Study to Investigate the Effect of Two Multiple-dose Regimens of BIA 3-202 on the Pharmacokinetics and Motor Response of Levodopa, and on the Erythrocyte Comt Activity in Parkinson's Disease Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (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 determine the effect of two different multiple-dose regimens of nebicapone in comparison to placebo and entacapone 200 mg on the pharmacokinetics of levodopa in Parkinson's Disease (PD) patients.

Detailed description

STUDY DESIGN AND METHODOLOGY: This was a multicentre, randomised, double-blind, placebo- and active-controlled, four-way crossover study. The study consisted of 4 treatment periods in at least 16 patients with PD treated with standard release levodopa/carbidopa (Sinemet®). Patients were randomly assigned to treatment with placebo, nebicapone 75 mg, nebicapone 150 mg or entacapone 200 mg (Comtan®) in 4 different sequences.

Conditions

• Parkinson's Disease (PD)

Interventions

Type	Name	Description
DRUG	Placebo	Matching placebo capsules
DRUG	BIA 3-202	Capsules containing nebicapone 75 mg or 150 mg
DRUG	Comtan®	Capsules containing entacapone 200 mg
DRUG	Sinemet®	levodopa/carbidopa (Sinemet®) dose patient used to take

Timeline

• Start date: 2005-03-01
• Primary completion: 2005-11-01
• Completion: 2005-11-01
• First posted: 2016-07-15
• Last updated: 2016-07-15