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
• Sponsor: UCB Pharma
• Information provided by (Responsible Party): UCB Pharma

Tracking Information

• First Submitted Date: November 3, 2010
• First Posted Date: November 5, 2010
• Results First Submitted Date: December 18, 2012
• Results First Posted Date: January 24, 2013
• Last Update Posted Date: May 21, 2018
• Study Start Date: June 2010
• Actual Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 18, 2012)

• 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.

Original Primary Outcome Measures (submitted: November 4, 2010)

• Number of subjects reporting at least 1 Treatment-Emergent Adverse Event (TEAE) during the treatment period (24 weeks) [ Time Frame: During the treatment period (24 weeks) ]
  Number of subjects reporting at least 1 Treatment-Emergent Adverse Event (TEAE) during the treatment period (24 weeks)
• Number of subjects prematurely discontinuing due to a TEAE during the treatment period (24 weeks) [ Time Frame: During the treatment period (24 weeks) ]
  Number of subjects prematurely discontinuing due to a TEAE during the treatment period (24 weeks)

Current Secondary Outcome Measures (submitted: December 18, 2012)

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.

Original Secondary Outcome Measures (submitted: November 4, 2010)

Retention rate: Number of patients continuing to take lacosamide at the end of the 24-week treatment phase divided by the number of patients who took at least 1 study drug dose [ Time Frame: End of Treatment Period (24-week) ]

Retention rate: Number of patients continuing to take lacosamide at the end of the 24-week treatment phase divided by the number of patients who took at least 1 study drug dose

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Partial Epilepsies

Intervention

Drug: Lacosamide

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®

Study Arms

Experimental: Lacosamide

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

Intervention: Drug: Lacosamide

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 4, 2012): 100
• Original Estimated Enrollment (submitted: November 4, 2010): 200
• Actual Study Completion Date: December 2011
• Actual Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT01235403
• Other Study ID Numbers: SP1007; 2010-019268-35 ( EudraCT Number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: UCB Pharma
• Study Sponsor: UCB Pharma
• Collaborators: Not Provided

Investigators

• Study Director: UCB Clinical Trial Call Center; +1 877 822 9493 (UCB)

• PRS Account: UCB Pharma
• Verification Date: March 2018