CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 239 enrolled
Drug / intervention
Lacosamide Tablet +1 moredrug
Likely dose
Lacosamide Tablet 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/NCT02408549
NCT02408549Phase 3Completed
CompareCT.gov

An Open-label, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of Lacosamide as Adjunctive Therapy for Uncontrolled Primary Generalized Tonic-Clonic Seizures in Subjects With Idiopathic Generalized Epilepsy

UCB BIOSCIENCES, Inc.·interventional·Posted Apr 3, 2015·Updated Dec 14, 2023

In Brief

A Phase 3 clinical trial evaluating Lacosamide Tablet and Lacosamide Oral Solution for Epilepsy. Completed, enrolled 239 participants across 87 sites in 21 countries.

Detailed Summary

Assessment of long-term safety and efficacy of oral lacosamide (LCM) as an adjunctive therapy for uncontrolled primary generalized tonic-clonic seizures (PGTCS) in subjects \>= 4 years of age with idiopathic generalized epilepsy (IGE). This study will enroll subjects from the LCM SP0982 \[NCT02408523\] study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesAustralia, Brazil, Bulgaria, China, Czechia, France, Germany, Hungary, Israel, Italy, Japan, Mexico, Poland, Portugal, Romania, Russia, Slovakia, South Korea, Spain, Taiwan, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 3, 2015
Enrollment StartAug 3, 2015
Primary CompletionMar 30, 2023
TodayJul 2, 2026
Enrollment to primary: 7.7 yearsPosted 11.2 years ago

Interventions

Lacosamide Tabletdrug

* Active substance: Lacosamide * Pharmaceutical form: Tablet * Concentration: 50 mg and 100 mg * Route of Administration: Oral administration

Lacosamide Oral Solutiondrug

* Active substance: Lacosamide * Pharmaceutical form: Oral solution * Concentration: 10 mg/ml * Route of Administration: Oral administration