SP0967
SP0967
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Lacosamide as Adjunctive Therapy in Subjects With Epilepsy >=1 Month to <4 Years of Age With Partial-Onset Seizures
Brief summary
The purpose of this trial is to assess the efficacy, safety and tolerabilty of lacosamide administered as add-on therapy with 1 to 3 anti-seizure medications. This trial is for children aged 1 month to less than 4 years with epilepsy who currently have uncontrolled partial-onset seizures.
Medical Condition
Epilepsy with partial-onset seizures
Min. Age
1
Months
Max. Age
47
Months
Who Can Join?
All
Status
Active, not recruiting
Inclusion criteria
• Subject is male or female from >=1 month (ie, 4 weeks after full term [37 weeks gestational age]) to <4 years of age • Subject has a diagnosis of epilepsy with partial-onset seizures. The results of >=1 prior EEG and >=1 magnetic resonance imaging/computerized tomography scan should be consistent with this diagnosis • Subject weighs >=4 kg to <30 kg at Visit 1 • Subject has experienced >=2 partial-onset seizures with or without secondary generalization during each consecutive 7-day period during the 2 weeks prior to Visit 1 • Subject has >=2 partial-onset seizures with or without secondary generalization during the End-of-Baseline video EEG. Electrographic seizures are defined as recognizable ictal patterns on an EEG involving >=2 contiguous electrodes. The seizures are initiated as a unilateral or strongly asymmetric abnormal epileptiform discharge lasting a total of >10 seconds • Subject is on a stable (concurrently or sequentially) dosage regimen of 1 to 3 AEDs. The dosage regimen of concomitant AED therapy must be kept constant for a period of >=2 weeks prior to Visit 1. A stable daily dosage regimen of a concomitant benzodiazepine (BZD) will be considered as a concomitant AED • Vagus nerve stimulation (VNS) is allowed and will not be counted as a concomitant AED. The VNS device must have been implanted for >=6 months prior to Visit 1; device settings must be kept stable for >=2 weeks prior to Visit 1 and kept stable during the Baseline, Treatment, and Transition Periods. Use of the VNS device magnet is allowed • Subject is an acceptable candidate for venipuncture
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 diet that has either changed within the 4 weeks prior to Visit 1 or is expected to change during the study • Subject has creatinine clearance <30 mL/minute • Subject has a clinically relevant ECG abnormality, in the opinion of the investigator (eg, second or third degree heart block at rest or a corrected QT interval [QTc] >=450 ms) • Subject has a hemodynamically significant congenital heart disease • Subject has an arrhythmic heart condition requiring medical therapy • Subject has a known history of severe anaphylactic reaction secondary to medication intake or serious blood dyscrasias • Subject has nonepileptic events that could be confused with seizures. Subjects may be included if epileptic events can be clearly distinguished and the frequency meets the study inclusion criteria • Subject has a current diagnosis of Lennox-Gastaut syndrome, epilepsia partialis continua, primary generalized epilepsy, Dravet Syndorme, or seizures that are not of partial-onset origin • Subject has a history of generalized convulsive status epilepticus <=2 months prior to Screening (Visit 1) • 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 cardiac sodium channelopathy, such as Brugada syndrome
Study Medication Description
Study Medication:
Vimpat®
Other Descriptive Name:
lacosamide
Placebo
Yes
Comparator:
No
Refer to a friend
Study Dates
June 2015
Actual Start Date of Enrollment
April 2020
Planned Study Completion Date
General Information
Study ID:
SP0967
EudraCT Number:
2013-000717-20
CT.gov Number:
NCT02477839
Phase:
Phase 3