AN OPEN-LABEL, MULTICENTER, FOLLOW-UP STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF BRIVARACETAM USED AS ADJUNCTIVE TREATMENT IN SUBJECTS AGED 16 YEARS OR OLDER WITH EPILEPSY
- Conditions
- epilepsy - seizure10029305
- Registration Number
- NL-OMON41449
- Lead Sponsor
- CB BioSciences GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 16
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary efficacy variable is the POS (type I) seizure frequency<br /><br>standardized to a 28-day duration. This will be summarized by 3-month periods<br /><br>over the Evaluation Period.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary efficacy variables are as follows:<br /><br>* Seizure frequency per 28 days for all seizure types (I+II+III) by 3-month<br /><br>periods over the Evaluation Period<br /><br>* Proportion of seizure-free days for all seizure types (I+II+III) by 3-month<br /><br>periods over the Evaluation Period<br /><br>* Proportion of continuously seizure-free subjects for all seizure types<br /><br>(I+II+III) by 3-month periods over the Evaluation Period<br /><br>* Responder rate in POS (type I) by 3-month periods over the Evaluation Period.<br /><br>A responder is defined as a subject with a *50% reduction in seizure frequency<br /><br>from the Baseline Period for the double-blind study N01358.</p><br>