CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 19 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/NCT02124564
NCT02124564Phase 3Completed
CompareCT.gov

Multicenter, Open-Label, Long-Term Study to Investigate the Safety of Conversion to Lacosamide at Doses up to 600 mg/Day as Monotherapy in Japanese Adults With Partial-Onset Seizures With or Without Secondary Generalization

UCB Japan Co. Ltd.·interventional·Posted Apr 28, 2014·Updated Oct 28, 2019

In Brief

A Phase 3 clinical trial evaluating Lacosamide for Epilepsy and Partial-onset Seizures. Completed, enrolled 19 participants across 11 sites.

Detailed Summary

This study is to evaluate the long-term safety and tolerability of Lacosamide (LCM) 200 mg/day to LCM 600 mg/day taken in monotherapy in Japanese subjects who currently have partial-onset seizures with or without secondary generalization and who are treated with a single Anti-Epileptic Drug (AED) with marketing approval in Japan.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy, Partial-onset Seizures
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 28, 2014
Enrollment StartApr 1, 2014
Primary CompletionNov 21, 2017
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 12.2 years ago

Interventions

Lacosamidedrug

Lacosamide (LCM) immediate-release, film-coated tablets at a strength of 50 mg orally administered twice daily in two equally divided doses. * 4-week Titration Period: Starting on LCM 100 mg/day increased by 100 mg/day each week until 400 mg/day dose reached at the beginning of Week 4 . * The AED Withdrawal Period and Monotherapy Period (52- week Evaluation Period plus a Follow Up Period): During the AED Withdrawal and Monotherapy Period, the investigator may increase or decrease the dose of LCM to optimize tolerability and seizure control. The LCM dose may be decreased no lower than 200 mg/day or increased, no faster than 100 mg/day per week, up to 600 mg/day.