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-CZ
- 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 ethosuximide.
•Subject is currently being treated with vigabatrin or has discontinued use <12 months prior to Visit 1. Subjects who were previously treated with vigabatrin and have discontinued use >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.
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