At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 48 enrolled
Drug / intervention
Lacosamidedrug
Likely dose
Not stated in 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.
A Multicenter, Open-Label, Follow-Up Study to Assess the Long-Term Use of Oral Lacosamide in Study Participants Who Completed EP0034 or SP848 and Received Lacosamide Treatment
In Brief
A Phase 3 clinical trial evaluating Lacosamide for Epilepsy. Completed, enrolled 48 participants across 15 sites in 6 countries.
Detailed Summary
The purpose of the study is to assess the long-term use of lacosamide oral solution dosed at 2 mg/kg/day to 12 mg/kg/day when administered to pediatric study participants with epilepsy who have completed NCT01964560 (EP0034) or NCT00938912 (SP848).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesGeorgia, Hungary, Moldova, Romania, Taiwan, Ukraine
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedNov 2020
Enrollment StartDec 2020
Primary CompletionFeb 2025
TodayJul 2026
First PostedNov 13, 2020
Enrollment StartDec 28, 2020
Primary CompletionFeb 12, 2025
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 5.6 years ago
Interventions
Lacosamidedrug
* Pharmaceutical form: Oral-solution * Route of administration: Oral use Subjects will receive lacosamide in a pre-specified sequence during the Treatment Period.