CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 64 enrolled
Drug / intervention
BIA 2-093 +1 moredrug
Likely dose
BIA 2-093 20mgfrom 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/NCT02171195
NCT02171195Phase 1Completed
CompareCT.gov

A Single Centre, Phase I, Double-blind, Randomised, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetic Profile and Effects on EEG of Single Rising Oral Doses of BIA 2-093 When Given to Healthy Male Adult Volunteers.

Bial - Portela C S.A.·interventional·Posted Jun 24, 2014·Updated Jul 20, 2016

In Brief

A Phase 1 clinical trial evaluating BIA 2-093 and Placebo for Epilepsy. Completed, enrolled 64 participants across 1 site.

Detailed Summary

The purpose of this study is to determine the safety and tolerability of single rising oral doses of BIA 2-093 (proposed doses 20mg, 50mg, 100mg, 200mg, 400mg, 600mg, 900mg and 1200mg) in groups of 8 healthy male adult volunteers.

Study Details

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

Timeline

Phase 1CompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 24, 2014
Enrollment StartJul 1, 2000
Primary CompletionOct 1, 2000
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 12.0 years ago

Interventions

BIA 2-093drug

BIA 2-093 20mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg, 1200 mg

Placebodrug

Identical placebo administered as oral tablets with 200 ml potable water.