Partial onset epilepsy with or without generalization MedDRA version: 12.1 Level: LLT Classification code 10065336 Term: Partial epilepsy
Conditions
Interventions
Trade Name: Vimpat
Pharmaceutical Form: Tablet
Sponsors
UCB Pharma SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Independent Ethics Committee (IEC) approved written informed consent is signed and dated by the patient (adult or minor) and by the parent(s) or legal representative if applicable. 2. Subject/legal representative is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule or medication intake according to the judgment of the investigator. 3. Subject is male or female, = 16 years old. 4. Patient has epilepsy and is experiencing partial-onset epilepsy, whether or not secondarily generalized, classifiable according to the International Classification of Epileptic Seizures confirmed by appropriate diagnosis. 5. Patient presents with between 1 and 14 partial-onset seizures per month over a 3-month historical Baseline seizure count. 6. Patient is being treated with 1 or 3 concomitant marketed antiepileptic drugs at study entry. Benzodiazepine taken chronically, whatever the indication is permitted and counted as 1 of the anticonvulsant treatments. Vagus-nerve stimulation is permitted as a concomitant treatment provided that at the entry visit, the device has been implanted for more than 6 months and the stimulation parameters have been stable for at least 1 month prior to the entry visit. Vagus-nerve stimulation will be counted as a concomitant antiepileptic drug. 7. Concomitant antiepileptic drugs are taken at a stable dose regimen for at least 4 weeks before the entry visit. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Previous exposure to VIMPAT®. 2. Subject has participated in another study of an investigational medication (or a medical device) within the last 2 months or is currently participating in another study. 3. Subject has a history of questionable compliance to visit schedule or medication intake; subject not expected to complete the study. 4. Subject has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the subject’s ability to participate in this study. 5. Subject has a known hypersensitivity to any components of VIMPAT® tablets (lacosamide, soja or peanuts or any of the excipients). 6. Subject has a known II° or III° AV-block. 7. Subject with partial onset seizures that are not clearly identifiable (ex seizures limited to psychic auras, or subtle vegetative changes). 8. Subject has a history of generalized epilepsy. 9. Subject has a history of status epilepticus within the 12-month period prior to the inclusion into the study. 10. Patient has seizures that are uncountable due to clustering during the 12 week period prior to inclusion. 11. Patient has a current or previous diagnosis of pseudoseizures, conversion disorders, or other nonepileptic events that could be confused with seizures. 12. Subject is pregnant or nursing and/or a woman of childbearing potential who is not surgically sterile, 2 years postmenopausal or does not practice adequate contraception, for the duration of the study. 13. Subject has a history of suicide attempt, has received professional counseling for suicidal ideation, or is currently experiencing active suicidal ideation. 14. Subject has a medical condition that could reasonably be expected to interfere with drug absorption, distribution, metabolism, or excretion (e.g., end stage renal disease, patients on dialysis, patients with severe hepatic impairment). Patients with mild to moderate renal impairment may participate in the study. 15. Subject has a progressive cerebral disease, a progressive degenerative neurological disease or a cerebral tumor. 16. Patient is taking any of the following concomitant medications: Subject is currently on felbamate. Subject is currently on vigabatrin, or subject has been on vigabatrin and no visual fields examination report is available, including standard static (Humphrey or Octopus) or kinetic perimetry (Goldman), or if results of these examinations are abnormal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective is to evaluate if a flexible dose escalation, up to 400mg/day (maximum recommended dose), or to a lower dose, clinically effective for an individual patient, improves lacosamide (Vimpat) tolerability. ;Secondary Objective: The objective is to evaluate if a flexible dose escalation, up to 400mg/day (maximum recommended dose), or to a lower dose, clinically effective for an individual patient, improves lacosamide (Vimpat) effectiveness. ;Primary end point(s): Safety assessments will be made using the spontaneous reporting of adverse events. - Incidence of AEs: Serious AE, TEAE, discontinuation or LCM dose reduction because of any TEAE - Additional safety variables including vital signs, neurological and physical examination abnormalities. - AE frequency by study period, titration and maintenance. - AE frequency by concomitant AEDs exposure (by each AED and by class Na+ channel /not) | — |
Countries
France
Outcome results
None listed