A Sequential Multiple Ascending Dose Study of the Safety and Pharmacokinetics of Eslicarbazepine Acetate in Adult Healthy Volunteers

Epilepsy Clinical Trial

Official title: A Randomized, Double-Blind, Placebo-Controlled, Sequential Multiple Ascending Dose Study of the Safety and Pharmacokinetics of Eslicarbazepine Acetate in Adult Healthy Volunteers

Status Completed

Clinical Trial Summary

Randomized, double-blind, placebo-controlled, sequential multiple ascending dose study to determine a maximum tolerated dose

Clinical Trial Description

This study was designed as a randomized, double-blind, placebo-controlled, sequential multiple ascending dose study to assess the safety and pharmacokinetics of supratherapeutic doses of eslicarbazepine acetate in 32 healthy adult male and female subjects, with 8 subjects per treatment group. In each study group, subjects were to receive single doses of eslicarbazepine acetate or placebo once daily for 5 days.

A series of screening evaluations was performed within a 21-day period prior to the first dose of study medication in order to determine the eligibility of prospective study participants for the trial. Eligible subjects reported to the clinic on Day -1 prior to study medication administration and remained in the clinic until clinic discharge on Day 7. Plasma and urine samples were collected throughout the study to determine the pharmacokinetics of eslicarbazepine acetate and its metabolites. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy

• NCT number: NCT01879332
• Study type: Interventional
• Source: Bial - Portela C S.A.
• Status: Completed
• Phase: Phase 1
• Start date: December 2006
• Completion date: February 2007