An open-label (treatment received will be known) follow-up study to evaluate the safety and efficacy of brivaracetam when used treating partial onset seizures for a long period of time in patients with epilepsy (=16 years to 80 years)

Phase 1

• Conditions: Epilepsy; MedDRA version: 18.1Level: PTClassification code 10015037Term: EpilepsySystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2010-020345-27-NL
• Lead Sponsor: CB Biosciences Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-05-11
• Study Completion: 2019-04-18
• Last Update Posted: 18 March 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 766

Inclusion Criteria

1) An Independent Ethics Committee (IEC)/Institutional Review Board (IRB) approved written informed consent signed and dated by the subject.
2) Male/female without mental impairment from 18 years 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 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.
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.
Are the trial subjects under 18? no
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 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the long-term safety and tolerability of BRV at individualized doses up to a maximum of 200mg/day in focal epilepsy subjects.;Secondary Objective: To evaluate the maintenance of efficacy of BRV over time.;Primary end point(s): 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 focal epilepsy subjects. Safety variables are AEs, laboratory tests (including hematology, blood chemistry, urinalysis, and pregnancy test), ECG, physical examination, neurological examination, vital signs, and body weight.;Timepoint(s) of evaluation of this end point: Continuously observed throughout the study.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): To evaluate the maintenance of efficacy of BRV over time. The primary efficacy variable is the POS (type I) seizure frequency standardized to a 28 day duration. ;Timepoint(s) of evaluation of this end point: This will be summarized by 3 month periods over the Evaluation Period.