CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 120 enrolled
Drug / intervention
Lacosamidedrug
Likely dose
Lacosamide 50 mgfrom 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/NCT01484977
NCT01484977Phase 3Completed
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Open-label, Single Arm, Study Evaluating Tolerability and Efficacy of Lacosamide When Added to Levetiracetam With Withdrawal of Concomitant Sodium Channel Blocking Antiepileptic Drug in Subjects With Uncontrolled Partial-onset Seizures

UCB Pharma·interventional·Posted Dec 5, 2011·Updated Jul 18, 2018

In Brief

A Phase 3 clinical trial evaluating Lacosamide for Epilepsy. Completed, enrolled 120 participants across 54 sites in 9 countries.

Detailed Summary

The main purpose of this study is to evaluate the effectiveness of the study drug lacosamide (200-600 mg/day) when added to a stable dose of levetiracetam (1000-3000 mg/day) with withdrawal of the concomitant sodium channel blocking-antiepileptic drug (AEDs) in subjects not well controlled on their current regimen.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesAustralia, Bulgaria, Denmark, France, Germany, Romania, Spain, Sweden, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 5, 2011
Enrollment StartDec 1, 2011
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 14.6 years ago

Interventions

Lacosamidedrug

50 mg and 100 mg lacosamide tablets will be combined and taken in two equal doses per day to provide the required total daily dosage of 100 - 600 mg/day. Subjects were titrated to a minimum of 200 mg/ day during the Treatment Period. Maximum duration of study drug administration is approximately 23 weeks.