Nonpyschotic Behavioural Side Effects in Subjects With Epilepsy MedDRA version: 14.1 Level: PT Classification code 10015037 Term: Epilepsy System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: Brivaracetam
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: BRIVARACETAM
CAS Number: 357336-20-0
Current Sponsor code: ucb34714
Other descriptive name: (2S)-2-[(4R)-2-oxo-4
Sponsors
UCB Pharma SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. An Independent Ethics Committee (IEC)/Institutional Review Board (IRB) approved written Informed Consent form is signed and dated by the subject or by the parent(s) or legal representative. The Informed Consent form or a specific Assent form, where required, will be signed and dated by minors. 2. Subject is male or female and 16 years or older. Subjects under 18 years of age may be included only where legally permitted and ethically accepted. 3. Subjects having completed the Treatment Period of N01394, N01395, or other planned BRV Phase 3b studies in epilepsy, and have access to the present study. 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 (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 ethinylestradiol 30?g per intake (or ethinylestradiol 50?g 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/legal representative 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? yes Number of subjects for this age range: 13 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 624 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 13
Exclusion criteria
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 prior study. 2. Severe medical, neurological, or psychiatric disorders, or laboratory values that 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 the last visit of the previous study or at the EV of N01372 if not completed at the last visit of the previous study.
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 as adjunctive treatment in adult subjects with epilepsy;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 as adjunctive treatment in adult subjects with epilepsy.;Timepoint(s) of evaluation of this end point: 'Occurrence of a TEAE', ?Withdrawal due to an AE? and ?Occurrence of an SAE? ongoing on a daily basis. Laboratory tests (hematology, blood chemistry, urinalysis), and Vital signs (systolic blood pressure, diastolic blood pressure, pulse rate) every 3 months; and body weight, ECG, and Physical and neurological examinations every 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Evaluate the maintenance of efficacy of BRV over time by means of seizure count information recorded on the Daily Record Card. Secondary efficacy variables for subjects with focal-onset epilepsy are the partial-onset seizure (POS) (Type I) frequency per 28 days during the Evaluation Period, the percent reduction in POS (Type I) frequency per 28 days from Baseline of the previous study to the Evaluation Period, and the responder rate in POS (Type I) frequency over the Evaluation Period. A responder is defined as a subject with a ?50% reduction in seizure frequency from the Baseline Period of the previous study. No secondary efficacy variables are defined for subjects with generalized epilepsy. Other efficacy variables for subjects with focal-onset epilepsy include the percentage of subjects continuously seizure free for all seizure types (I+II+III) for at least 6 months and at least 12 months during the Evaluation Period. Other efficacy variables for subjects with generalized epilepsy include the number of generalized (Type II) seizure days per 28 days during the Evaluation Period, the percent reduction in generalized (Type II) seizure days per 28 days from Baseline of the previous study to the Evaluation Period, the responder rate for generalized (Type II) seizure days over the Evaluation Period, and the percentage of subjects continuously seizure free for all seizure types (I+II+III) for at least 6 months and at least 12 months during the Evaluation Period.;Timepoint(s) of evaluation of this end point: Ongoing on a daily basis | — |
Countries
France, Germany, Italy, Spain, United Kingdom, United States
Contacts
Public ContactClin Trial Reg & Results Disclosure
UCB BIOSCIENCES GmbH
Outcome results
None listed