Epilepsy MedDRA version: 18.0 Level: PT Classification code 10015037 Term: Epilepsy System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Vimpat 50mg film-coated tablets
Product Name: Vimpat
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: LACOSAMIDE
Other descriptive name: LCM, SPM927
Concentration unit: mg mill
Sponsors
UCB Biosciences Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A signed informed consent has been obtained from the parent/legal representative and assent has been obtained from the subject (when possible or as required according to local Institutional Review Boards [IRBs]/Independent Ethics Committees [IECs]). 2. Subject and /or caregiver (which may be a parent, a legal representative, or other caregiver) are willing and able to comply with all study requirements including maintaining a daily seizure diary. 3. Subject is male or female, =1 month to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subject has previously participated in this study, subject has been assigned to LCM in a previous LCM study, or subject has ever received LCM. 2. Subject is currently participating or has participated within the last 2 months in any study of an investigational drug or experimental device. 3. Subject has a history of convulsive status epilepticus within 1 month prior to Visit 1. 4. Subject has a current or previous diagnosis of pseudoseizures, conversion disorders, or other nonepileptic ictal events that could be confused with seizures. 5. Subject has exclusively typical absence (Type IIA1) or atypical absence (Type IIA2) seizures (no other generalized seizure types are reported), or has only partial onset seizures (Type I). 6. Subject has primary generalized tonic-clonic seizures with a diagnosis of idiopathic generalized epilepsy. 7. Subject has any medical or psychiatric condition that in the opinion of the investigator, could jeopardize the subject’s health or would compromise the subject’s ability to participate in this study. 8. Subject =6 years of age has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response (“Yes”) to either Question 4 or Question 5 of the Columbia Suicide Severity Rating Scale (C-SSRS) at Screening. 9. Subject has a known hypersensitivity to any components of the investigational medicinal product (IMP). 10. Subject has a medical condition that could reasonably be expected to interfere with drug absorption, distribution, metabolism, or excretion. 11. Subject has a known history of severe anaphylactic reaction or serious blood dyscrasias. 12. Subject has any history of alcohol or drug abuse within the previous 2 years. 13. Subject has an acute or sub-acutely progressive central nervous system disease. Subject has epilepsy secondary to a progressing cerebral disease or any other progressively neurodegenerative disease (malignant brain tumor or Rasmussen Syndrome). 14. Subject has alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin levels =2x the upper limit of normal (ULN) or has alkaline phosphatase levels =3x ULN. 15. Subject has impaired renal function (ie, creatinine clearance is lower than 30mL/min) at Visit 1. 16. Subject has sick sinus syndrome without a pacemaker, or second or third degree atrioventricular (AV) block. 17. Subject has a clinically relevant ECG abnormality, in the opinion of the principal investigator (ie, second or third degree heart block or a corrected QT interval [QTc] greater than 450ms). 18. Subject has hemodynamically significant heart disease (eg, heart failure). 19. Subject has an arrhythmic heart condition requiring medical therapy. 20. Subject has a known cardiac sodium channelopathy, such as Brugada syndrome. 21.Female subject who is pregnant or nursing, and/or a female subject of childbearing potential who is not surgically sterile or does not practice 1 highly effective method of contraception (according to International Conference on Harmonisation [ICH] guidance defined as those that result in a failure rate of less than 1% per year when used consistently and correctly), unless sexually abstinent, for the duration of the study. Female subject of childbearing potential taking enzyme inducing antiepileptic drugs (EI AEDs): (carbamazepine, phenytoin, barbiturates, primidone, topir
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the safety and tolerability of LCM when added to 1 to 3 concomitant AEDs in pediatric subjects with epilepsy syndromes associated with generalized seizures ;Secondary Objective: • To obtain preliminary efficacy data of LCM on seizure frequency in pediatric epilepsy syndromes associated with generalized seizures • To evaluate the PK of LCM in subjects =1 month to <18 years of age.;Primary end point(s): 1) Changes in count of generalized spike-wave discharges on 24-hour ambulatory electroencephalogram (EEG) from Visit 2 to Visit 6 2) Change in days with any generalized seizures (absence, myoclonic, clonic, tonic, tonic-clonic, atonic, partial evolving to secondarily generalized) per 28 days from the Baseline Period to the Maintenance Period ;Timepoint(s) of evaluation of this end point: 1) Visit 2; Visit 6 2) Baseline Period to the Maintenance Period (approximately 24 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Changes in count of 3Hz spike-wave discharges (during waking hours) on 24-hour ambulatory EEG from Visit 2 to Visit 6 2) AEs as reported spontaneously by the subject and/or caregiver, or observed by the investigator 3) Subject withdrawals due to AEs ;Timepoint(s) of evaluation of this end point: 1) Visit 2; Visit 6 2) From baseline to end of study 3) From baseline to end of study | — |
Countries
European Union, France, Germany, Hungary, Poland, United States
Contacts
Public ContactClin Trial Reg & Results disclosure
UCB Biosciences GmbH
Outcome results
None listed