Clinical trial NCT01235403: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Partial Epilepsies
Keywords: Epilepsy treatment.
Anti-epileptic drugs
Seizures
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2010-11-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Study
timeFrame: During the study ( up to 24 - 28 weeks)
measure: Number of Subjects Prematurely Discontinuing Due to a TEAE During the Study
timeFrame: During the study (up to 24 - 28 weeks)
Secondary outcomes:
measure: Percentage of Subjects Retained on Vimpat Through the End of the 24-week Treatment Period
timeFrame: End of Treatment Period (24-week)
Other outcomes:
Locations:
city: Amiens
country: France
city: Aubenas
country: France
city: Auxerre
country: France
city: Bordeaux
country: France
city: Brest
country: France
city: Caen
country: France
city: Carpentras
country: France
city: Chateaubriand
country: France
city: Colmar
country: France
city: Créteil
country: France
city: Gap
country: France
city: Gonesse
country: France
city: La Rochelle
country: France
city: Laval
country: France
city: Limoges
country: France
city: Marseille
country: France
city: Montluçon
country: France
city: Nice
country: France
city: Nîmes
country: France
city: Paris
country: France
city: Perpignan
country: France
city: Poitiers
country: France
city: Pringy
country: France
city: Rennes
country: France
city: Rouen
country: France
city: Saint Aubin Sur Cie
country: France
city: Saint Julien En Gengvois
country: France
city: Saint-Malo
country: France
city: St Brieuc
country: France
city: Toulouse
country: France
city: Vienne
country: France
city: Villeurbanne
country: France
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: 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.