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

Partial Epilepsies Clinical Trial

— SELF  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01235403
• Other study ID #: SP1007
• Secondary ID: 2010-019268-35
• Status: Completed
• Phase: Phase 4
• Start date: June 2010
• Est. completion date: December 2011

Study information

• Verified date: March 2018
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Country where clinical trial is conducted

France, 

References & 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; — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Percentage of Subjects Retained on Vimpat Through the End of the 24-week Treatment Period	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.	End of Treatment Period (24-week)

External Links

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