Trial to Assess Optimized Dosage of Lacosamide as add-on Therapy in Patients With Partial Onset Seizure
SELF
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
2 other identifiers
interventional
100
1 country
32
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jun 2010
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 3, 2010
CompletedFirst Posted
Study publicly available on registry
November 5, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedResults Posted
Study results publicly available
January 24, 2013
CompletedMay 21, 2018
March 1, 2018
1.5 years
November 3, 2010
December 18, 2012
March 14, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
During the study ( up to 24 - 28 weeks)
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.
During the study (up to 24 - 28 weeks)
Secondary Outcomes (1)
Percentage of Subjects Retained on Vimpat Through the End of the 24-week Treatment Period
End of Treatment Period (24-week)
Study Arms (1)
Lacosamide
EXPERIMENTALFlexible dosing between 200mg/day and 400mg/day
Interventions
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
Eligibility Criteria
You may qualify if:
- Patient has a diagnosis of partial-onset epilepsy with or without secondary generalization
- Currently taking 1 to 3 concomitant marketed antiepileptic drugs
- years and older at study entry
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (32)
Unknown Facility
Amiens, France
Unknown Facility
Aubenas, France
Unknown Facility
Auxerre, France
Unknown Facility
Bordeaux, France
Unknown Facility
Brest, France
Unknown Facility
Caen, France
Unknown Facility
Carpentras, France
Unknown Facility
Châteaubriand, France
Unknown Facility
Colmar, France
Unknown Facility
Créteil, France
Unknown Facility
Gap, France
Unknown Facility
Gonesse, France
Unknown Facility
La Rochelle, France
Unknown Facility
Laval, France
Unknown Facility
Limoges, France
Unknown Facility
Marseille, France
Unknown Facility
Montluçon, France
Unknown Facility
Nice, France
Unknown Facility
Nîmes, France
Unknown Facility
Paris, France
Unknown Facility
Perpignan, France
Unknown Facility
Poitiers, France
Unknown Facility
Pringy, France
Unknown Facility
Rennes, France
Unknown Facility
Rouen, France
Unknown Facility
Saint Aubin Sur Cie, France
Unknown Facility
Saint Julien En Gengvois, France
Unknown Facility
Saint-Brieuc, France
Unknown Facility
St-Malo, France
Unknown Facility
Toulouse, France
Unknown Facility
Vienne, France
Unknown Facility
Villeurbanne, France
Related Publications (1)
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.
PMID: 28597842RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB Clinical Trial Call Center
- Organization
- UCB
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2010
First Posted
November 5, 2010
Study Start
June 1, 2010
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
May 21, 2018
Results First Posted
January 24, 2013
Record last verified: 2018-03