Epilepsy with partial onset seizures MedDRA version: 18.0 Level: PT Classification code 10015037 Term: Epilepsy System Organ Class: 10029205 - Nervous system disorders
Conditions
Sponsors
UCB Biosciences Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject is male or female from =1 month (ie, 4 weeks after full term [37 weeks gestational age]) to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subject has experienced febrile seizures exclusively. The occurrence of febrile seizures in addition to partial-onset seizures is not exclusionary. • Subject is on a ketogenic or other specialized diet for the treatment of epilepsy. If the subject was on a ketogenic or other specialized diet in the past, they must be off this diet for =2 months prior to Visit 1. • Subject has an alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin level =2 times the upper limit of normal (ULN), or creatinine clearance 12 months prior to Visit 1 are eligible. • Subject has been treated with felbamate and has experienced any serious toxicity issues (defined as liver failure, aplastic anemia) with this treatment. Subjects treated with felbamate for <12 months are excluded. Subjects treated with felbamate for =12 months prior to Visit 1 and who have not experienced serious toxicity issues are eligible. • Subject has an acute or subacutely 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). • Subject has a known sodium channelopathy, such as Brugada syndrome.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the efficacy of LCM administered concomitantly with 1 to 3 AEDs in subjects =1 month to <4 years of age with epilepsy who currently have uncontrolled partial-onset seizures.;Secondary Objective: The secondary objective is to evaluate the safety and tolerability of LCM in subjects =1 month to <4 years of age with epilepsy who currently have uncontrolled partial-onset seizures.;Primary end point(s): 1) The primary efficacy variable will be the proportion of responders where a responder is a subject experiencing a 50% or greater reduction in their ADF of electrographic partial-onset seizures recorded on the 72-hour End-of-Maintenance Period video-EEG compared to the 72-hour End-of-Baseline Period video-EEG. 2) Adverse events reported spontaneously by the subject’s parent(s) and/or legal representative(s)/caregiver(s) (in accordance with local regulation) or observed by the investigator 3) Subject withdrawals due to AEs;Timepoint(s) of evaluation of this end point: 1) End-of-Maintenance Period video-EEG (Visit 6) compared to the 72-hour End-of-Baseline Period video-EEG (Visits 2 and 3) 2) From Baseline to End-of-Treatment 3) From Baseline to End-of-Treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Percent and absolute change in ADF of electrographic partial-onset seizures from the End-of-Baseline Period video-EEG to the End-of-Maintenance Period video-EEG 2) Proportion of subjects who achieved “seizure-free” status (yes/no) for subjects who completed at least 48 hours of interpretable video-EEG recording during the End-of-Maintenance Period video-EEG 3) Proportion of subjects experiencing a =25% to 75% reduction in ADF of electrographic partial-onset seizures from the end-of-Baseline Period video-EEG to the End-of-Maintenance Period video-EEG 4) Proportion of subjects experiencing no change in ADF of electrographic partial-onset seizures (between <25% reduction and <25% increase) from the End-of-Baseline Period video-EEG to the End-of-Maintenance Period video-EEG 5) Proportion of subjects experiencing an increase in ADF of electrographic partial-onset seizures of =25% from the End-of-Baseline Period video-EEG to the End-of-Maintenance Period video-EEG;Timepoint(s) of evaluation of this end point: 1) From the end-of-Baseline Period video-EEG (Visits 2 and 3) to the End-of-Maintenance Period video-EEG (Visit 6) 2) During the the end-of-Baseline Period video-EEG (Visit 6) 3) From the end-of-Baseline Period video-EEG (Visits 2 and 3) to the End-of-Maintenance Period video-EEG (Visit 6) 4) From the end-of-Baseline Period video-EEG (Visits 2 and 3) to the End-of-Maintenance Period video-EEG (Visit 6) 5) From the end-of-Baseline Period video-EEG (Visits 2 and 3) to the End-of-Maintenance Period video-EEG (Visit 6) | — |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Georgia, Germany, Greece, Hungary, Israel, Italy, Korea, Republic of, Lithuania, Mexico, Moldova, Republic of, Poland, Portugal, Romania, Serbia, Slovakia, Spain, Taiwan, Thailand, Ukraine, United Kingdom, United States
Contacts
Public ContactClin Trial Reg & Results Disclosure
UCB Biosciences GmbH
Outcome results
None listed