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

Phase 4

Completed

• Conditions: Partial Epilepsies
• Interventions: Drug: Lacosamide

• Registration Number: NCT01235403
• Lead Sponsor: UCB Pharma

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-11-03
• Study First Submitted QC: 2010-11-04
• Study First Posted: 2010-11-05
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Results First Submitted: 2012-12-18
• Results First Submitted QC: 2012-12-18
• Results First Posted: 2013-01-24
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-14
• Last Update Posted: 2018-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lacosamide	Lacosamide	Flexible dosing between 200mg/day and 400mg/day

Primary Outcome Measures

Name	Time	Method
Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Study	During the study ( up to 24 - 28 weeks)	Number of subjects reporting at least 1 Treatment-Emergent Adverse Event (TEAE) during the study. The study is comprised of a 12-week Titration Phase, a 12 -week Maintenance Phase, and a 3 to 4 week Taper Phase if needed.
Number of Subjects Prematurely Discontinuing Due to a TEAE During the Study	During the study (up to 24 - 28 weeks)	Number of subjects prematurely discontinuing due to a TEAE during the study. The study is comprised of a 12-week Titration Phase, a 12 -week Maintenance Phase, and a 3 to 4 week Taper Phase if needed.

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects Retained on Vimpat Through the End of the 24-week Treatment Period	End of Treatment Period (24-week)	The number of subjects continuing on Vimpat up to and including Visit 4 (Week 24) divided by the number of patients who took at least 1 dose of Vimpat multiplied by 100.; The overall Treatment Period comprises of a 12-week Titration Phase and 12-week Maintenance Phase.