An open-label, multinational, multicenter, follow-up study to evaluate the long-term safety and efficacy of brivaracetam, used at a flexible dose up to a maximum of 150 mg/day, in subjects aged 16 years or older suffering from epilepsy. - ND

Phase 1

• Conditions: MedDRA version: 9.1Level: LLTClassification code 10065336Term: Partial epilepsy; epilesy

• Registration Number: EUCTR2008-001433-98-IT
• Lead Sponsor: CB Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-10
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

An IEC/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 subjects from 16 years or older. Subjects under 18 years may only be
included where legally permitted and ethically accepted. In Germany all subjects must
be older than 18 years.
Subjects with epilepsy who participated in previous brivaracetam trials which allow
access to the present trial.
Subjects from whom the Investigator believes a reasonable potential benefit from the
long-term administration of brivaracetam may be expected.
Female subjects without childbearing potential (premenarcheal; 2 years
postmenopausal bilateral oophorectomy or ovariectomy, bilateral salpingectomy,
complete hysterectomy, congenital sterility) are eligible. Female subjects with
childbearing potential are eligible if they use a medically accepted contraceptive
method for the duration of the trial (Intra Uterine Device, diaphragm with spermicide,
male or female condom with spermicide; oral hormonal contraceptive, non-oral
hormonal contraceptive medication, bilateral tubal ligation, bilateral tubal implant,
monogamous relationship with vasectomized partner).Oral or depot contraceptive
treatment with at least 30 µg [or 50 µg if associated with other antiepileptic drugs
known as inducers] ethinylestradiol per intake must be used in conjunction with a
barrier method. 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. Sexual inactivity might be accepted on a case-by-case basis.
Subject/legally acceptable representative considered as reliable and capable of adhering
to the protocol (e.g. 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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Severe medical, neurological and psychiatric disorders, including current suicidal
ideation or behaviour, or laboratory values which may have an impact on the safety of
the subject, as determined by the investigator.
Poor compliance with the visit schedule or medication intake in the previous
brivaracetam trial.
Participation in any clinical study of another investigation drug or device during the
trial.
Pregnant or lactating woman.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified