NCT01710657

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

A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Lacosamide as Adjunctive Therapy in Japanese and Chinese Adults With Uncontrolled Partial-Onset Seizures With or Without Secondary Generalization

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 548 (actual)
• Sponsor: UCB Pharma SA · Industry
• Sex: All
• Age: 16 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Epilepsy
• Partial Onset Seizures

Interventions

Type	Name	Description
DRUG	Lacosamide 50 mg	* Active Substance: Lacosamide * Pharmaceutical Form: Film-coated tablet * Concentration: 50 mg * Route of Administration: Oral use
DRUG	Lacosamide 100 mg	* Active Substance: Lacosamide * Pharmaceutical Form: Film-coated tablet * Concentration: 100 mg * Route of Administration: Oral use
DRUG	Placebo	Matching oral Placebo tablets twice daily for 16 weeks.

Timeline

• Start date: 2012-09-01
• Primary completion: 2014-07-01
• Completion: 2014-08-01
• First posted: 2012-10-19
• Last updated: 2017-08-25
• Results posted: 2015-02-09

Locations

76 sites across 2 countries: China, Japan