Overview

Status:Not yet recruiting
Keywords:Brivaracetam , Epilepsy , Neurology
IRB Number:00064076
Specialty:Neurology
Sub Specialty:Epilepsy

Brief Summary

This is a Phase 3, open-label, long-term follow-up (LTFU), multicenter, noncomparative, and

single-arm study of brivaracetam (BRV). The primary objective is to evaluate the long-term

safety and tolerability of BRV at individualized doses up to a maximum of 200mg/day in

epilepsy subjects. The secondary objective is to evaluate the maintenance of efficacy of BRV

over time. Exploratory objectives are to assess the effects of BRV on subjects’ Health-related

Quality of Life (HRQoL), obtain information on the direct medical resource use, explore any

change in socio-professional status, and assess the role of gene variants of SV2 in affecting

response to BRV (as part of a DNA analysis at the program level).

This study will enroll subjects (≥16 years) from N01358 with refractory partial onset seizures

(POS) whether or not secondarily generalized. Subjects under 18 years may only be included

where legally permitted and ethically accepted. Subjects have to complete the Treatment

Period of N01358 prior to enrollment into N01379.

Subjects from N01358 will be started on a BRV dose of 150mg/day at study entry and should

be maintained at this dose for at least 2 weeks unless the subject is unable to tolerate

treatment. The BRV dose can be adjusted based on the individual subject’s seizure control and

tolerability. However, the BRV dose may not exceed 200mg/day during the study. During the

Evaluation Period, subjects will be invited to visit the clinical site monthly in the first

3 months and every 3 months thereafter. The completion of the Evaluation Period or early

discontinuation from N01379 is followed by a Down-Titration Period of up to 4 weeks and

by a subsequent Posttreatment Period (between 2 and 4 weeks) during which the subject does

not receive study drug.

Principle Investigator: Matthew Sweney
Principle Department: Pediatric Administration
Co Investigator:

Contact Information

Name:Fumiko Alger
Phone:801-213-4180
Email:fumiko.alger@hsc.utah.edu

Inclusion Criteria

  1. An Independent Ethics Committee (IEC)/Institutional Review Board (IRB) approved
  2. 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. In countries and sites where a DNA analysis is accepted, an additional Informed Consent form will have to be signed by subjects coming from N01358. Deoxyribonucleic acid analysis will be performed only in adults, and the subject can withdraw consent to the use of the sample at any time. Mentally impaired subjects will be excluded. In case the consent is withdrawn, the site must request the destruction of the sample.
  3. Male/female subject from 16 years or older. Subject under 18 years may only be included where legally permitted and ethically accepted.
  4. Subject completed the Treatment Period of N01358 or the Evaluation Period of N01258.
  5. Subject for whom the Investigator believes a reasonable benefit from the long-term administration of BRV may be expected.
  6. 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.
  7. 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

  1. Subject has developed hypersensitivity to any components of the investigationalmedicinal product (IMP) or comparative drugs as stated in this protocol during the course of the core studies
  1. Severe medical, neurological, or psychiatric disorders, or laboratory values which may have an impact on the safety of the subject
  2. Poor compliance with the visit schedule or medication intake in the previous BRV studies
  3. Planned participation in any other clinical study of another investigational drug or device during this study
  4. Pregnant or lactating woman
  5. Any medical condition which, in the Investigator’s opinion, warrants exclusion
  6. 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 the Entry Visit