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

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Pharma
• Treatments: Lacosamide

Criteria

Inclusion Criteria:

• Patient has a diagnosis of partial-onset epilepsy with or without secondary generalization

• Currently taking 1 to 3 concomitant marketed antiepileptic drugs

• 18 years and older at study entry

Exclusion Criteria:

• Previous use of lacosamide

• Hypersensitivity to any component of lacosamide

• Patients with partial onset seizures not clearly identifiable

• History of generalized epilepsy

• History of status epilepticus within last 12 months

• Uncountable seizures due to clustering within last 12 weeks

• Non epileptic events, including pseudoseizures, conversion disorder that could be confused with seizures

• History of drug or alcohol abuse

• History of suicide attempt

• Progressive cerebral disease

• Concomitant treatment of felbamate

• Prior or concomitant vigabatrin use

• Under legal protection