A study to test the safety and efficacy of lacosamide in children with epilepsy who are already taking anti-epileptic medications. Children aged 4 years and older but less than 17 year can participate in the study
- Conditions
- EpilepsyMedDRA version: 14.1Level: PTClassification code 10015037Term: EpilepsySystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2012-004996-38-SK
- Lead Sponsor
- CB BIOSCIENCES, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
1).An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the parent(s) or legal representative. The Informed Consent form or a specific Assent form, where required, will be signed and dated by minors.
2). 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.
3). Subject is male or female from =4 years to <17 years of age.
4). Subject has a diagnosis of epilepsy with partial-onset seizures. The results of =1 prior electroencephalogram (EEG) AND 1 prior magnetic resonance imaging/computerized tomography scan should be consistent with the above diagnosis.
5). Subject has been observed to have uncontrolled partial-onset seizures after an adequate course of treatment (in the opinion of the investigator) with =2 AEDs (concurrently or sequentially).
6). Subject must have been observed to have on average =2 partial onset seizures per 28 days with seizure free phase no longer than 21 days in the 8 week period prior to entry into the Baseline Period. During this study, subjects must have reported =2 partial onset seizures during the 8 week prospective Baseline Period to be eligible for randomization at Visit 2. (Note: In the case of simple partial onset seizures, only those seizures with motor signs will be counted towards meeting the inclusion criterion).
7). Subject is on a stable dosage regimen of 1 to =3 AEDs. The daily dosage regimen of concomitant AED therapy must be kept constant for a period of =4 weeks prior to the Baseline Period.
8). Vagal nerve stimulation is allowed and will not be counted as a concomitant AED. The VNS device must be implanted for =6 months before Visit 1, and the device settings must be stable for =4 weeks before Visit 1 and be kept stable during the Baseline Period. Use of the VNS device magnet is allowed.
Are the trial subjects under 18? yes
Number of subjects for this age range: 300
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
Subjects are not permitted to enroll in the study if any of the following criteria is met:
1). Subject has previously participated in this study or subject has been assigned to LCM in a previous LCM study.
2). Subject has participated in another study of an investigational medicinal product (IMP) or a medical device within =2 months of Visit 1 or is currently participating in another study of an IMP or a medical device.
3). Subject has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the subject’s ability to participate in this study.
4). Subject =6 years of age 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 Screening.
5). Subject has a known hypersensitivity to any component of the IMP or has ever received LCM.
6). 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 International Conference on Harmonisation [ICH] guidance defined as those that result in a failure rate of less than 1% per year when used consistently and correctly), unless sexually abstinent, for the duration of the study. Female subject of childbearing potential taking enzyme inducing antiepileptic drugs (EI AEDs: carbamazepine, phenytoin, barbiturates, primidone, topiramate, oxcarbazepine) who is not surgically sterile or does not practice 1 highly effective method of contraception according to the WHO recommendation (ie, depot medroxyprogesterone acetate, norethisterone enantate, intrauterine devices, combined injectables, and progestogen implants) with administration of EI AEDs OR does not practice 2 combined methods of contraception (ie, combined hormonal contraception plus barrier method with spermicidal agent), unless sexually abstinent, for the duration of the study.
7). Subject has a medical condition that could be expected in the opinion of the investigator to interfere with drug absorption, distribution, metabolism, or excretion.
8). Subject has experienced febrile seizures exclusively. The occurrence of febrile seizures in addition to other unprovoked seizures is not exclusionary.
9). Subject is on a ketogenic or other specialized diet. If the subject was on a specialized diet in the past, they must be off the diet for =2 months prior to the Baseline Period.
10). Subject has an alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin level =2 times the upper limit of normal (ULN), or creatinine clearance less than 50mL/min.
11). 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] greater than 450ms).
12). Subject has hemodynamically significant congenital heart disease.
13). Subject has an arrhythmic heart condition requiring medical therapy.
14). Subject has a known history of severe anaphylactic reaction or serious blood dyscrasias.
15). Subject has nonepileptic events that could be confused with seizures.
16). Subject has a current diagnosis of Lennox-Gastaut syndrome, primary generalized epilepsy, mixed seizure disorder (partial and primaril
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