CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 106 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/NCT02582866
NCT02582866Phase 3Completed
CompareCT.gov

A Multicenter, Open-label, Follow-up Study to Assess the Long-term Use of Lacosamide (Flexible Dose From 200 to 600 mg/Day) Used as Monotherapy in Subjects Who Completed SP0994 and Received Lacosamide Monotherapy Treatment

UCB Biopharma S.P.R.L.·interventional·Posted Oct 21, 2015·Updated Jun 6, 2023

In Brief

A Phase 3 clinical trial evaluating Lacosamide for Epilepsy. Completed, enrolled 106 participants across 46 sites in 15 countries.

Detailed Summary

Study is conducted to evaluate the long-term safety and tolerability of lacosamide (LCM) in patients receiving LCM in SP0994 \[NCT01465997\]. The study will enable collection of additional monotherapy safety data, and will facilitate access to treatment until commercial availability for monotherapy use.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesBulgaria, Finland, France, Germany, Japan, Latvia, Mexico, Philippines, Poland, Romania, Russia, South Korea, Sweden, Switzerland, Ukraine
CollaboratorsParexel

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 21, 2015
Enrollment StartJan 1, 2016
Primary CompletionJan 1, 2020
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 10.7 years ago

Interventions

Lacosamidedrug

* Pharmaceutical Form: Oral tablets * Concentration: 50 mg * Route of Administration: Oral administration