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

March 14, 2018 updated by: UCB Pharma

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Amiens, France
      • Aubenas, France
      • Auxerre, France
      • Bordeaux, France
      • Brest, France
      • Caen, France
      • Carpentras, France
      • Chateaubriand, France
      • Colmar, France
      • Créteil, France
      • Gap, France
      • Gonesse, France
      • La Rochelle, France
      • Laval, France
      • Limoges, France
      • Marseille, France
      • Montluçon, France
      • Nice, France
      • Nîmes, France
      • Paris, France
      • Perpignan, France
      • Poitiers, France
      • Pringy, France
      • Rennes, France
      • Rouen, France
      • Saint Aubin Sur Cie, France
      • Saint Julien En Gengvois, France
      • Saint-Malo, France
      • St Brieuc, France
      • Toulouse, France
      • Vienne, France
      • Villeurbanne, France

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Lacosamide
Flexible dosing between 200mg/day and 400mg/day

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®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During the study ( up to 24 - 28 weeks)
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.
During the study (up to 24 - 28 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

End of Treatment Period (24-week)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

November 3, 2010

First Submitted That Met QC Criteria

November 4, 2010

First Posted (ESTIMATE)

November 5, 2010

Study Record Updates

Last Update Posted (ACTUAL)

May 21, 2018

Last Update Submitted That Met QC Criteria

March 14, 2018

Last Verified

March 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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