Follow-up trial to evaluate Long-Term safety and efficacy of brivaracetam in subjects suffering from epilepsy

Phase 1

• Conditions: Epilepsy; MedDRA version: 19.0 Level: PT Classification code 10015037 Term: Epilepsy System Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2004-002140-10-SE
• Lead Sponsor: CB Pharma S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-03-29
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 1000

Inclusion Criteria

•An IEC/IRB approved written informed consent signed and dated by the subject or legally acceptable representative(s). The consent form or a specific assent form will be signed and dated by minors, according to country-specific regulations.
•Male/female subjects from 16 years or older. Subjects under 18 years may only be included where legally permitted and ethically accepted.
•Subjects with POS/PGS: inpatients or outpatients with epilepsy who participated in previous brivaracetam studies / programs which allow access to the present study. Subjects with ULD: inpatients or outpatients with epilepsy who were treated with brivaracetam in previous studies / programs which allow access to the present study.
•Subjects for whom the Investigator believes a reasonable benefit from the long-term administration of brivaracetam may be expected.
•Female subjects with childbearing potential:
o POS/PGS subjects: 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 study participation (Intra Uterine Device; diaphragm with spermicide; male or female condom with spermicide; oral hormonal contraceptive; non-oral hormonal contraceptive medication; bilateral tubal ligation; monogamous relationship with vasectomized partner). In particular, oral or depot contraceptive treatment with at least 30 µg [or 50 µg if associated with carbamazepine (CBZ) or other strong enzyme inducing drugs] 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 according to the judgment of the Investigator.
o ULD subjects: Female ULD subjects without childbearing potential (premenarcheal, postmenopausal for at least 2 years, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible. Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method. Oral or depot contraceptive treatment with at least 30 µg [or 50 µg ethinylestradiol per intake if associated with carbamazepine (or other strong enzyme inducers e.g. phenobarbital, primidone, oxcarbazepine)] must be used in conjunction with a barrier method. 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. 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 Inve

Exclusion Criteria

•Severe medical, neurological and psychiatric disorders, or laboratory values that
appeared during the core trials and which may have an impact on the safety of
the subject.
•Poor compliance with visit schedule or medication intake in previous brivaracetam trial.
•Participation in any clinical trial of another investigational drug or device during the study.
•Pregnant or lactating woman.

If the Investigator has any medically valid reason to doubt the eligibility of a subject, the subject should not be included into the trial. If however, the Investigator has any other kind of doubts concerning the eligibility, he/she should consult the Sponsor’s Clinical Study Physician or representative for clarification.

Study & Design

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