NCT01484977

eValuation of the Efficacy and toleRability of Vimpat When Added to lEvetiracetam

Open-label, Single Arm, Study Evaluating Tolerability and Efficacy of Lacosamide When Added to Levetiracetam With Withdrawal of Concomitant Sodium Channel Blocking Antiepileptic Drug in Subjects With Uncontrolled Partial-onset Seizures

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to evaluate the effectiveness of the study drug lacosamide (200-600 mg/day) when added to a stable dose of levetiracetam (1000-3000 mg/day) with withdrawal of the concomitant sodium channel blocking-antiepileptic drug (AEDs) in subjects not well controlled on their current regimen.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	Lacosamide	50 mg and 100 mg lacosamide tablets will be combined and taken in two equal doses per day to provide the required total daily dosage of 100 - 600 mg/day. Subjects were titrated to a minimum of 200 mg/ day during the Treatment Period. Maximum duration of study drug administration is approximately 23 weeks.

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2011-12-05
• Last updated: 2018-07-18
• Results posted: 2014-11-26

Locations

54 sites across 9 countries: United States, Australia, Bulgaria, Denmark, France, Germany, Romania, Spain, Sweden