NCT00955357

Trial to Assess Lacosamide as the First add-on Anti-epileptic Drug Treatment in Patients With Partial-onset Seizures

An Open-Label, Multicenter, Multinational Study of Lacosamide as First Add-On Anti-epileptic Drug (AED) Treatment in Subjects With Partial-Onset Seizures

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 461 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of oral Lacosamide as first add on treatment in subjects with uncontrolled partial-onset seizures after prior treatment with a monotherapy Antiepileptic Drug (AED) regimen compared to subjects who have received treatment with at least 2 AEDs.

Detailed description

The study consisted of 3 Periods: Period 1: a 1-week Screening Phase, Period 2: a 30-week Treatment Phase (consisting of a 6-week Titration Phase and a 24-week Maintenance Phase), and Period 3: a 3-week Taper/Safety Follow-Up Phase.

Conditions

• Partial Epilepsies

Interventions

Type	Name	Description
DRUG	Lacosamide	Oral Lacosamide: Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet Twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week

Timeline

• Start date: 2009-08-01
• Primary completion: 2013-04-01
• Completion: 2013-08-01
• First posted: 2009-08-10
• Last updated: 2018-07-17
• Results posted: 2014-05-01

Locations

109 sites across 15 countries: United States, Austria, Bulgaria, Czechia, Denmark, Finland, France, Greece, Italy, Mexico, Romania, Russia, Spain, Switzerland, Turkey (Türkiye)