Epilepsy with Partial Onset Seizures MedDRA version: 20.0 Level: PT Classification code 10015037 Term: Epilepsy System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Vimpat
Product Name: Lacosamide
Pharmaceutical Form: Syrup
INN or Proposed INN: LACOSAMIDE
CAS Number: 175481-36-4
Current Sponsor code: SPM927
Concentration unit: mg/ml milligram(s)/milli
Sponsors
UCB Biosciences Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form (ICF) is signed and dated by the subject or legal representative. The ICF or a specific Assent form, where required, will be signed and dated by minors. 2. Subject has completed the Transition Period of SP0967 or SP0969 for the treatment of uncontrolled partial-onset seizures in pediatric epilepsy. 3. Subject is expected to benefit from participation, in the opinion of the investigator. 4. Subject/legal representative is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and medication intake according to the judgment of the investigator. 5. Subject is male or female aged 1 month to ==65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subject is receiving any investigational drugs or using any experimental devices in addition to lacosamide. 2. Subject meets a mandatory withdrawal criterion (ie, MUST withdraw criterion) for SP0967 or SP0969, or is experiencing an ongoing serious AE (SAE). 3. For subjects =6 years of age, subject 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 Visit 1. 4. 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 the International Council on Harmonisation [ICH] guidance defined as those that result in a failure rate 2x the upper limit of normal (ULN) of any of the following: ALT, AST, ALP, or >ULN total bilirubin ( =1.5xULN, fractionate bilirubin to identify possible undiagnosed Gilbert's syndrome (ie, direct bilirubin >35%). For enrolled subjects with a Baseline result >ULN for ALT, AST, ALP, or total bilirubin, a Baseline diagnosis and/or the cause of any clinically meaningful elevation must be understood and recorded in the electronic Case Report Form (eCRF).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the long-term safety and tolerability of lacosamide in pediatric subjects;Secondary Objective: To assess the efficacy of lacosamide during long-term exposure in pediatric subjects;Primary end point(s): 1) Number of subjects reporting at least one Treatment-emergent Adverse Event (TEAE) during the study 2) Number of subjects reporting at least one Treatment-emergent Adverse Event (TEAE) leading to discontinuation from the study ;Timepoint(s) of evaluation of this end point: 1) From Baseline to End of Treatment period 2) From Baseline to End of Treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Percentage of seizure free days at the end of Year 1; 2) Percentage of seizure free days at end of Year 2;Timepoint(s) of evaluation of this end point: 1) End of Year 1 of the Study (approximately 52 weeks) 2) End of Year 2 of the Study (approximately 96 weeks) | — |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, Israel, Italy, Korea, Republic of, Latvia, Lithuania, Mexico, Moldova, Republic of, Montenegro, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, Slovenia, Spain, Sweden, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactClin Trial Reg & Results Disclosure
UCB BIOSCIENCES GmbH
Outcome results
None listed