NCT00520741

Trial to Demonstrate the Efficacy and Safety of Conversion to Lacosamide Monotherapy for Partial-onset Seizures

A Historical-controlled, Multicenter, Double-blind, Randomized Trial to Assess the Efficacy and Safety of Conversion to Lacosamide 400 mg/Day Monotherapy in Subjects With Partial-onset Seizures

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 426 (actual)
• Sponsor: UCB BIOSCIENCES, Inc. · Industry
• Sex: All
• Age: 16 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The objective of this historical-controlled trial is to demonstrate the efficacy and safety of conversion to Lacosamide monotherapy in subjects with Partial-onset Seizures who are withdrawn from 1 to 2 marketed antiepileptic drugs.

Detailed description

Sudden unexplained death in epilepsy have been reported in epilepsy patients. A causal relationship with the administration of antiepileptic drugs has not been established. The most important known risk factor for sudden unexplained death in epilepsy (SUDEP) is the occurrence and frequency of generalized tonic-clonic seizures (GTCS). Twenty-seven patients with only GTCS were enrolled in the conversion to monotherapy study. In this study, two patients with only GTCS had SUDEP. Due to the potential increased risk of SUDEP in patients with only GTCS in a trial setting, the 1 remaining patient with only GTCS was withdrawn from this study.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	Lacosamide	50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.
DRUG	Lacosamide	50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.

Timeline

• Start date: 2007-08-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2007-08-27
• Last updated: 2018-07-19
• Results posted: 2014-04-23

Locations

158 sites across 13 countries: United States, Australia, Austria, Canada, Denmark, France, Germany, Ireland, Italy, Poland, Puerto Rico, Spain, United Kingdom