A Trial to Evaluate the Efficacy and Safety of Adjunctive Therapy With Lacosamide in Adults With Partial-Onset Seizures

Phase 3 Completed 548 enrolled UCB Pharma UCB Japan Co. Ltd. · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of 200 and 400 mg/day of orally administered Lacosamide as adjunctive therapy compared with placebo in Japanese and Chinese adults with uncontrolled Partial-Onset Seizures with or without secondary generalization.

Timeline

Start: 2012-09
Primary completion: 2014-07
Completion: 2014-08

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo vs Lacosamide 400 mg/Day; p <0.001; % Reduction over Placebo 39.6 (95% CI 30.5 to 47.6); ANCOVA NCT01710657 ↗

registry analysis (superiority or other test); Placebo vs Lacosamide 200 mg/Day; p < 0.001; % Reduction over Placebo 29.4 (95% CI 18.7 to 38.7); ANCOVA NCT01710657 ↗

Publications

Results Doty P, Hebert D, Mathy FX, Byrnes W, Zackheim J, Simontacchi K. Development of lacosamide for the treatment of partial-onset seizures. Ann N Y Acad Sci. 2013 Jul;1291(1):56-68. doi: 10.1111/nyas.12213.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lacosamide	Other / unclassified	100 mg	Oral
Subject	Lacosamide	Other / unclassified	200 mg	Oral