CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 16 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
BIA 2-093 3000 mg once dailyfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01879332
NCT01879332Phase 1Completed

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

Bial - Portela C S.A.·interventional·Posted Jun 17, 2013·Updated Dec 19, 2014

In Brief

A Phase 1 clinical trial evaluating Placebo, BIA 2-093 3000 mg once daily, and 1 other intervention for Epilepsy. Completed, enrolled 16 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 17, 2013
Enrollment StartDec 1, 2006
Primary CompletionFeb 1, 2007
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 13.0 years ago

Interventions

Placebodrug

Matching placebo tablets for oral administration

BIA 2-093 3000 mg once dailydrug

Eslicarbazepine acetate 600 mg tablets for oral administration

BIA 2-093 3600 mg once dailydrug

Eslicarbazepine acetate 600 mg tablets for oral administration