CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 242 enrolled
Drug / intervention
Lacosamide Tablet +3 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/NCT02408523
NCT02408523Phase 3Completed
CompareCT.gov

A Double-blind, Randomized, Placebo-controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety 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 17, 2020

In Brief

A Phase 3 clinical trial evaluating Lacosamide Tablet, Lasosamide Oral Solution, and 2 other interventions for Epilepsy. Completed, enrolled 242 participants across 115 sites in 22 countries.

Detailed Summary

Evaluating efficacy \& safety of lacosamide versus Placebo in a blinded fashion as add-on Therapy for Primary Generalized Tonic-clonic (PGTC) seizures in subject 4 years of age or greater with idiopathic generalized epilepsy currently taking 1 to 3 antiepileptic drugs. Maximum duration of study drug administration is 28 weeks. Eligible subjects may choose to enter the open-label extension study after completion.

Study Details

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

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 3, 2015
Enrollment StartApr 1, 2015
Primary CompletionApr 1, 2019
Study CompletionJun 1, 2019
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 11.2 years ago

Interventions

Lacosamide Tabletdrug

* Active Substance: Lacosamide * Pharmaceutical Form: Film-coated Tablet * Concentration: 50 mg * Route of Administration: Oral use

Lasosamide Oral Solutiondrug

* Active Substance: Lacosamide * Pharmaceutical Form: Oral Solution * Concentration: 10 mg/ml * Route of Administration: Oral use

Placebo Tabletother

* Active Substance: Placebo * Pharmaceutical Form: Film-coated Tablet * Concentration: 50 mg * Route of Administration: Oral use

Placebo Oral Solutionother

* Active Substance: Placebo * Pharmaceutical Form: Oral Solution * Concentration: 10 mg/ml * Route of Administration: Oral use