Trial to Assess Optimized Dosage of Lacosamide as add-on Therapy in Patients With Partial Onset Seizure (SELF)
|ClinicalTrials.gov Identifier: NCT01235403|
Recruitment Status : Completed
First Posted : November 5, 2010
Results First Posted : January 24, 2013
Last Update Posted : May 21, 2018
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
|Condition or disease||Intervention/treatment||Phase|
|Partial Epilepsies||Drug: Lacosamide||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||June 2010|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
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 Name: Vimpat®
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01235403
|La Rochelle, France|
|Saint Aubin Sur Cie, France|
|Saint Julien En Gengvois, France|
|St Brieuc, France|
|Study Director:||UCB Clinical Trial Call Center||+1 877 822 9493 (UCB)|