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OpenTrials
Completed

NCT Number: NCT01235403

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

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

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Key information

Conditions

Partial Epilepsies Brain Diseases Central Nervous System Diseases Epilepsies, Partial Epilepsy Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Amiens, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lacosamide

Drug

Lacosamide : 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks.

Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day.

Taper phase if needed: 3 to 4 weeks

Other names: Vimpat®

Primary outcomes

  1. Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Study

    Time frame: 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.

  2. Number of Subjects Prematurely Discontinuing Due to a TEAE During the Study

    Time frame: 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 outcomes

  1. Percentage of Subjects Retained on Vimpat Through the End of the 24-week Treatment Period

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study title

A Multicenter, Open Label Study to Evaluate the Tolerability, Safety and Efficacy of Lacosamide (200mg - 400mg/Day) as add-on Therapy for Patients With Partial Onset Epilepsy Using a Flexible Dose-escalation Schedule and Individualized Maintenance Doses

Acronym: SELF

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 5, 2010
Registry last updated
May 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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