EFFICACY AND SAFETY OF LACOSAMIDE AS ADJUNCTIVE THERAPY IN SUBJECTS =1 MONTH TO <4 YEARS WITH PARTIAL-ONSET SEIZURES
- Conditions
- Epilepsy with partial onset seizuresMedDRA version: 21.0Level: PTClassification code 10015037Term: EpilepsySystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2013-000717-20-FI
- Lead Sponsor
- CB Biosciences Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 244
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 =4kg to <30kg 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 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
Are the trial subjects under 18? yes
Number of subjects for this age range: 244
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
• 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 <30mL/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] =450ms).
• 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 Syndrome, or seizures that are not of partial-onset origin.
• Subject has a history of 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 sodium channelopathy, such as Brugada syndrome.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method