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

UCB

Status and phase: Completed; Phase 4

Conditions: Partial Epilepsies

Treatments: Drug: Lacosamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01235403

2010-019268-35 (EudraCT Number)

SP1007

Details and patient eligibility

About

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

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Lacosamide

Experimental group

Description:

Flexible dosing between 200mg/day and 400mg/day

Treatment:

Drug: Lacosamide