ONG TERM STUDY OF ADJUNCTIVE ADMINISTRATION OF BRIVARACETAM IN CHILDREN WITH EPILEPSY
- Conditions
- ocalization-related, generalized or undetermined whether focal or generalized epileptic syndrome, according to ILAE classificationMedDRA version: 21.0Level: PTClassification code 10015037Term: EpilepsySystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2011-000374-60-GB
- Lead Sponsor
- CB Pharma SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 600
To be eligible to participate in this study, all of the following criteria must be met as specified.
Inclusion criteria for all subjects
- 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(s). The Consent form or a specific Assent form, where required, will be signed and dated by minors.
- Subject/legal representative is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, or medication intake (including BRV oral solution or tablets) according to the judgment of the Investigator.
- For female subjects, the subject is
1)Not of childbearing potential OR Of childbearing potential, and
Is not sexually active,Has a negative pregnancy test
OR
2)Of childbearing potential, and Is sexually active, Has a negative pregnancy test
- Understands the consequences and potential risks of inadequately protected sexual activity, understands and properly uses contraceptive methods, and is willing to inform the Investigator of any contraception changes. Medically acceptable contraceptive methods for the study include, but are not limited to:
Oral or depot contraceptive treatment with at least ethinylestradiol 30µg per intake or ethinylestradiol 50µg per intake if also taking one of the following: carbamazepine, phenobarbital, primidone, phenytoin, oxcarbazepine, St. John's Wort, or rifampicin
Barrier contraception: intrauterine device, diaphragm with spermicide, male or female condom with spermicide
Abstinence from sexual intercourse
Inclusion criteria for LTFU subjects only
- Male or female subjects having participated in a core study with a confirmed diagnosis of epilepsy and for whom a reasonable benefit from long-term administration of BRV is expected.
Inclusion criteria for directly enrolled subjects only
- Subject is a male or female =4 years to <17 years of age.
- Subject has a clinical diagnosis of POS according to the ILAE classification.
- Subject has an EEG compatible with the clinical diagnosis of POS.
- Subject has been observed to have uncontrolled POS after an adequate course of treatment (in the opinion of the Investigator) with at least 1 AED (concurrently or sequentially).
- Subject had at least 1 seizure (POS) during the 3 weeks before the ScrV.
- Subject is taking at least 1 AED. All AEDs need to be at a stable dose for at least 7 days before the ScrV. Vagal nerve stimulator stable for at least 2 weeks before the ScrV is allowed and will be counted as a concomitant AED. Benzodiazepines taken more than once a week (for any indication) will be considered as a concomitant AED.
Are the trial subjects under 18? yes
Number of subjects for this age range: 600
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 are met as specified.
Exclusion criteria for all subjects
-Subject is a pregnant or nursing female.
-Subject has severe medical, neurological, or psychiatric disorders or laboratory values, which may have an impact on the safety of the subject.
-Subject has planned participation in any clinical study of another investigational drug or device.
-Subject has any medical condition, which in the Investigator’s opinion, warrants exclusion.
-Subject has >1.5x upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or >1.0xULN total bilirubin (=1.5xULN total bilirubin if known Gilbert’s syndrome).
-Subject has chronic liver disease.
Exclusion criteria for LTFU subjects only
- Subject had hypersensitivity to BRV or excipients or comparative drugs as stated in this protocol during the course of the core study.
- Subject had poor compliance with the visit schedule or medication intake in the core study.
- Subject =6 years of age has a lifetime history of suicide attempt (including actual attempt,interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response (Yes”) to Question 5 of the Columbia-Suicide Severity
Rating Scale (C-SSRS) at the EV. If a subject has active suicidal ideation without a specific plan as indicated by a positive response (Yes”) to Question 4 of Columbia-Suicide Severity Rating Scale (C-SSRS) at the EV, the subject should be referred immediately to a Mental
Healthcare Professional and may be excluded from the study based upon the Investigator’s judgment of benefit/risk of continuing the subject in the study/on study medication.
Exclusion criteria for directly enrolled subjects only
- Subject has previously received BRV.
- Subject had concomitant use of LEV at the ScrV. In addition, the use of LEV is prohibited for at least 4 weeks prior to the ScrV.
- Subject has epilepsy secondary to a progressive cerebral disease or tumor, or any other progressively neurodegenerative disease. Stable arteriovenous malformations, meningiomas or other benign tumors may be acceptable according to Investigator’s opinion.
- Subject has a history of primary generalized epilepsy.
- Subject has a history of status epilepticus in the month immediately prior to the ScrV or during the Up Titration Period.
- Subject has a history or presence of pseudoseizures.
- Subject is suffering only from febrile seizures.
- Subject is on felbamate with less than 18 months continuous exposure. Subject who has taken felbamate for a combined duration of treatment and wash out of <18 months before the ScrV.
- Subjects treated with vigabatrin who have visual field defects.
- Subject has an allergy to pyrrolidone derivatives or investigational product excipients or a history of multiple drug allergies.
- Subject has any clinically significant acute or chronic illness as determined during the physical examination or from other information available to the Investigator (eg, bone marrow depression, chronic hepatic disease, severe renal impairment, psychiatric disorder).
- Subject has an underlying disease or is receiving a treatment that may interfere with the absorption, distribution, metabolism, and elimination of the study drug.
- Subject has any medical condition that might interfere with his/her study participation (eg, serious infect
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To document the long-term safety and tolerability of BRV;Secondary Objective: To assess the efficacy of BRV during long-term exposure;Primary end point(s): 1. Incidence of treatment-emergent adverse events (TEAEs) during the<br>study<br>2. Incidence of treatment-emergent serious adverse events (SAEs)<br>during the study;Timepoint(s) of evaluation of this end point: 1-2: From Baseline to end of Study (up to 10 years)
- Secondary Outcome Measures
Name Time Method