Trial to Assess Optimized Dosage of Lacosamide as add-on Therapy in Patients With Partial Onset Seizure (SELF)
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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)|