NCT01243177

Trial Comparing the Efficacy and Safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR); Initial Monotherapy in Epilepsy; Subjects Aged 16 and Older

A Multicenter, Double-blind, Double-dummy, Randomized, Positive- Controlled Study Comparing the Efficacy and Safety of Lacosamide (200 to 600 mg/Day) to Controlled Release Carbamazepine (400 to 1200 mg/Day), Used as Monotherapy in Subjects (≥ 16 Years) Newly or Recently Diagnosed With Epilepsy and Experiencing Partial-onset or Generalized Tonic-clonic Seizures.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 888 (actual)
• Sponsor: UCB BIOSCIENCES GmbH · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

Compare efficacy and safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR) as monotherapy in newly or recently newly diagnosed subjects with a primary efficacy endpoint of 6-month seizure freedom. Noninferiority design to show a similar risk/benefit balance between Lacosamide (LCM) and Carbamazepine-CR (CBZ-CR).

Conditions

• Epilepsy
• Monotherapy

Interventions

Type	Name	Description
DRUG	Lacosamide	Lacosamide: * Strengths: 50 mg / 100 mg * Form: tablets * Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose * Duration: up to 118 weeks
DRUG	Carbamazepine-Controlled Release	Carbamazepine-CR: * Strengths: 200 mg * Form: tablets * Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose * Duration: up to 118 weeks

Timeline

• Start date: 2011-04-01
• Primary completion: 2015-07-01
• Completion: 2015-08-01
• First posted: 2010-11-18
• Last updated: 2021-02-02
• Results posted: 2016-02-23

Locations

184 sites across 29 countries: United States, Australia, Belgium, Bulgaria, Canada, Czechia, Finland, France, Germany, Greece, Hungary, Italy, Japan, Latvia, Lithuania, Mexico, Philippines, Poland, Portugal, Romania, Russia, Slovakia, South Korea, Spain, Sweden, Switzerland, Thailand, Ukraine, United Kingdom