NCT02284828

Effects of Eslicarbazepine Acetate (BIA 2-093) on Cognition and Psychomotor Function

Effects of Eslicarbazepine Acetate (BIA 2-093) on Cognition and Psychomotor Function: Single-blind, Single-centre, Single and Multiple Dose, Fixed-order, Placebocontrolled Trial in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Single-blind, single-centre, fixed-order study to evaluate the PD effects of a single oral dose and multiple oral doses of ESL (BIA 2-093) in healthy volunteers.

Detailed description

Single-blind, single-centre, fixed-order study to evaluate the PD effects of a single oral dose and multiple oral doses of ESL (BIA 2-093) in healthy volunteers. A single dose of oral ESL 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg each given QD. The single dose was chosen to assess the ESL acute response relationship with respect to cognitive and motor skill performance, and the multiple doses were chosen to further characterize the ESL dose response relationship with respect to cognitive and motor skill performance.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	BIA 2-093

Timeline

• Start date: 2007-09-01
• Primary completion: 2007-11-01
• Completion: 2007-11-01
• First posted: 2014-11-06
• Last updated: 2014-12-10
• Results posted: 2014-12-10