epilepsy - seizure
Conditions
Interventions
Oral film-coated tablets of BRV 10mg, BRV 25mg, and BRV 50mg will be used in
this study. The tablets of BRV will be packaged in bottles.
The BRV 10mg dose (20mg/day) will be used only for down-titra
Sponsors
UCB BioSciences GmbH
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: To be eligible to participate in this study, all of the following criteria must be met: 1. An Independent Ethics Committee (IEC)/Institutional Review Board (IRB) approved written informed consent signed and dated by the subject or by parent(s) or legally acceptable representative. The consent form or a specific assent form, where required, will be signed and dated by minors. 2. Male/female subject from 18years or older. 3. Subject completed the Treatment Period of N01358. 4. Subject for whom the Investigator believes a reasonable benefit from the long-term administration of BRV may be expected. 5. Female subject without childbearing potential (premenarcheal, postmenopausal for at least 2 years, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible. Female subject with childbearing potential are eligible if they use a medically accepted contraceptive method. Oral or depot contraceptive treatment with at least ethinylestradiol 30*g per intake (or ethinylestradiol 50*g per intake if associated with any strong enzyme inducer [eg, carbamazepine, phenobarbital, primidone, phenytoin, oxcarbazepine, St. John*s Wort, rifampicin]), monogamous relationship with vasectomized partner, or double-barrier contraception are acceptable methods. The subject must understand the consequences and potential risks of inadequately protected sexual activity, be educated about and understand the proper use of contraceptive methods, and undertake to inform the Investigator of any potential change in status. Abstinence will be considered as an acceptable method of contraception if the Investigator can document that the subject agrees to be compliant. 6. Subject/legally acceptable representative considered as reliable and capable of adhering to the protocol (eg, able to understand and complete diaries and questionnaires), visit schedule, or medication intake according to the judgment of the Investigator.
Exclusion criteria
Exclusion criteria: Subjects are not permitted to enroll in the study if any of the following criteria is met: 1. Subject has developed hypersensitivity to any components of the investigational medicinal product (IMP) or comparative drugs as stated in this protocol during the course of the core study 2. Severe medical, neurological, or psychiatric disorders, or laboratory values which may have an impact on the safety of the subject 3. Poor compliance with the visit schedule or medication intake in the previous BRV study 4. Planned participation in any other clinical study of another investigational drug or device during this study 5. Pregnant or lactating woman 6. Any medical condition which, in the Investigator*s opinion, warrants exclusion 7. Subject has a lifetime history of suicide attempt (including an active 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy variable is the POS (type I) seizure frequency standardized to a 28-day duration. This will be summarized by 3-month periods over the Evaluation Period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary efficacy variables are as follows: * Seizure frequency per 28 days for all seizure types (I+II+III) by 3-month periods over the Evaluation Period * Proportion of seizure-free days for all seizure types (I+II+III) by 3-month periods over the Evaluation Period * Proportion of continuously seizure-free subjects for all seizure types (I+II+III) by 3-month periods over the Evaluation Period * Responder rate in POS (type I) by 3-month periods over the Evaluation Period. A responder is defined as a subject with a *50% reduction in seizure frequency from the Baseline Period for the double-blind study N01358. | — |
Countries
Netherlands
Outcome results
None listed