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 PARTIAL ONSET SEIZURES - ND
- Conditions
- Partial onsetseizureMedDRA version: 13.1Level: HLTClassification code 10034093Term: Partial simple seizures NECSystem Organ Class: 10029205 - Nervous system disorders
- Registration Number
- EUCTR2010-020345-27-IT
- Lead Sponsor
- SCHWARZ BIOSCIENCES, INC A member of the UCB Group of Companies
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 766
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.
• Male/female subject from 16 years or older. Subject under 18 years may only be included where legally
permitted and ethically accepted.
• Subject completed the Treatment Period of N01358.
• Subject for whom the Investigator believes a reasonable benefit from the long-term administration of BRV may
be expected.
• 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 30µg per intake (or ethinylestradiol 50µg 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.
• 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
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
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 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
• Severe medical, neurological, or psychiatric disorders, or laboratory values which may have an impact on the
safety of the subject
• Poor compliance with the visit schedule or medication intake in the previous BRV study
• Planned participation in any other clinical study of another investigational drug or device during this study
• Pregnant or lactating woman
• Any medical condition which, in the Investigator’s opinion, warrants exclusion
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