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

Primary Purpose

Partial Epilepsies

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Lacosamide
Sponsored by
UCB Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Partial Epilepsies focused on measuring Epilepsy treatment., Anti-epileptic drugs, Seizures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lacosamide

Arm Description

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

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
November 3, 2010
Last Updated
March 14, 2018
Sponsor
UCB Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT01235403
Brief Title
Trial to Assess Optimized Dosage of Lacosamide as add-on Therapy in Patients With Partial Onset Seizure
Acronym
SELF
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partial Epilepsies
Keywords
Epilepsy treatment., Anti-epileptic drugs, Seizures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lacosamide
Arm Type
Experimental
Arm Description
Flexible dosing between 200mg/day and 400mg/day
Intervention Type
Drug
Intervention Name(s)
Lacosamide
Other Intervention Name(s)
Vimpat®
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Study
Description
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.
Time Frame
During the study ( up to 24 - 28 weeks)
Title
Number of Subjects Prematurely Discontinuing Due to a TEAE During the Study
Description
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.
Time Frame
During the study (up to 24 - 28 weeks)
Secondary Outcome Measure Information:
Title
Percentage of Subjects Retained on Vimpat Through the End of the 24-week Treatment Period
Description
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.
Time Frame
End of Treatment Period (24-week)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
Facility Information:
City
Amiens
Country
France
City
Aubenas
Country
France
City
Auxerre
Country
France
City
Bordeaux
Country
France
City
Brest
Country
France
City
Caen
Country
France
City
Carpentras
Country
France
City
Chateaubriand
Country
France
City
Colmar
Country
France
City
Créteil
Country
France
City
Gap
Country
France
City
Gonesse
Country
France
City
La Rochelle
Country
France
City
Laval
Country
France
City
Limoges
Country
France
City
Marseille
Country
France
City
Montluçon
Country
France
City
Nice
Country
France
City
Nîmes
Country
France
City
Paris
Country
France
City
Perpignan
Country
France
City
Poitiers
Country
France
City
Pringy
Country
France
City
Rennes
Country
France
City
Rouen
Country
France
City
Saint Aubin Sur Cie
Country
France
City
Saint Julien En Gengvois
Country
France
City
Saint-Malo
Country
France
City
St Brieuc
Country
France
City
Toulouse
Country
France
City
Vienne
Country
France
City
Villeurbanne
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
28597842
Citation
Baulac M, Coulbaut S, Doty P, McShea C, De Backer M, Bartolomei F, Vlaicu M. Adjunctive lacosamide for focal epilepsy: an open-label trial evaluating the impact of flexible titration and dosing on safety and seizure outcomes. Epileptic Disord. 2017 Jun 1;19(2):186-194. doi: 10.1684/epd.2017.0907.
Results Reference
result
Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

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

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