Epilepsy MedDRA version: 20.0 Level: PT Classification code 10015037 Term: Epilepsy System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: brivaracetam
Product Code: ucb 34714
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: BRIVARACETAM
CAS Number:
Sponsors
UCB BIOSCIENCES, INC.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • An Independent Ethics Committee (IEC)/Institutional Review Board (IRB) approved written informed consent signed and dated by the subject. 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 In case the consent is withdrawn, the site must request the destruction of the sample. • Male/female subject from 18 years or older. • Subject completed the Treatment Period of N01358 or the Evaluation Period of N01258. • 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 is considered 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: 0 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
Exclusion criteria: • 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 studies • 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 studies • 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 • Subject has been committed to an institution by administrative or judicial order • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long-term safety and tolerability of BRV at individualized doses up to a maximum of 200mg/day in 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 epilepsy subjects. Safety variables are AEs, laboratory tests (including hematology, blood chemistry, urinalysis, endocrinology 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Austria, Belgium, Brazil, Bulgaria, Canada, Czech Republic, Estonia, Finland, France, Germany, Hong Kong, Hungary, India, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Mexico, Netherlands, Russian Federation, Spain, Sweden, Taiwan, Ukraine, United Kingdom, United States
Contacts
Public ContactClin Trial Reg & Results disclosure
UCB BIOSCIENCES GmbH
Outcome results
None listed