drugset / Trial / NCT01235403

Trial to Assess Optimized Dosage of Lacosamide as add-on Therapy in Patients With Partial Onset Seizure

NCT01235403

Phase 4 Completed 100 enrolled UCB Pharma
NaSingle-groupOpen-labelTreatment

Summary

To evaluate if a flexible dose escalation of lacosamide, up to the maximum approved dose of 400 mg/day, or to a clinically effective lower dose for an individual patient, improves the tolerability and safety of lacosamide (200 mg to 400 mg/d) as add-on treatment for patients with partial onset epilepsy. Explanation of acronym: SELF = Safety Efficacy Lacosamide Flexibility

Timeline

Start
2010-06
Primary completion
2011-12
Completion
2011-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Lacosamide Other / unclassified 200 mg
Subject Lacosamide Other / unclassified 300 mg
Subject Lacosamide Other / unclassified 400 mg

Indications