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Trial record 1 of 1 for:    NCT01235403
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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
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Tracking Information
First Submitted Date  ICMJE November 3, 2010
First Posted Date  ICMJE November 5, 2010
Results First Submitted Date  ICMJE December 18, 2012
Results First Posted Date  ICMJE January 24, 2013
Last Update Posted Date May 21, 2018
Study Start Date  ICMJE June 2010
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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)
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Trial to Assess Optimized Dosage of Lacosamide as add-on Therapy in Patients With Partial Onset Seizure
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Partial Epilepsies
Intervention  ICMJE 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  ICMJE 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 4, 2012)
100
Original Estimated Enrollment  ICMJE
 (submitted: November 4, 2010)
200
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01235403
Other Study ID Numbers  ICMJE SP1007
2010-019268-35 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma
Study Sponsor  ICMJE UCB Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
PRS Account UCB Pharma
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP