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)

• Register: EUCTR
• Last refreshed on: 30 June 2019
• Main ID: EUCTR2010-020345-27-DE
• Date of registration: 26/11/2010
• Prospective Registration: Yes
• Primary sponsor: UCB BIOSCIENCES, INC.
• Public title: 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)
• Scientific title: AN OPEN-LABEL, MULTICENTER, FOLLOW-UP STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF BRIVARACETAM USED AS ADJUNCTIVE TREATMENT IN SUBJECTS AGED 16 YEARS OR OLDER WITH EPILEPSY
• Date of first enrolment: 12/04/2011
• Target sample size: 720
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-020345-27
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: yes; Other trial design description: noncomparative, and single-arm study; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no; Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

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

• Name: Clin Trial Reg & Results disclosure
• Affiliation: UCB BIOSCIENCES GmbH

• Name: Clin Trial Reg & Results disclosure
• Affiliation: UCB BIOSCIENCES GmbH

Key inclusion & exclusion 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:
• 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Epilepsy
MedDRA version: 20.0 Level: PT Classification code 10015037 Term: Epilepsy System Organ Class: 10029205 - Nervous system disorders

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

Product Name: brivaracetam
Product Code: ucb 34714
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: BRIVARACETAM
CAS Number: 357336-20-0
Current Sponsor code: ucb 34714
Other descriptive name: (a1S, 4R)-a-ethyl-2-oxo-4-propyl- 1-pyrrolidineacetamide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-

Product Name: brivaracetam
Product Code: ucb 34714
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: BRIVARACETAM
CAS Number: 357336-20-0
Current Sponsor code: ucb 34714
Other descriptive name: (a1S, 4R)-a-ethyl-2-oxo-4-propyl- 1-pyrrolidineacetamide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-

Product Name: brivaracetam
Product Code: ucb 34714
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: BRIVARACETAM
CAS Number: 357336-20-0
Current Sponsor code: ucb 34714
Other descriptive name: (a1S, 4R)-a-ethyl-2-oxo-4-propyl- 1-pyrrolidineacetamide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Continuously observed throughout the study.

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.

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.

Secondary Objective: To evaluate the maintenance of efficacy of BRV over time.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: This will be summarized by 3 month periods over the Evaluation Period.

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.

Secondary ID(s)

2010-020345-27-BE

NCT01339559

N01379

Source(s) of Monetary Support

UCB BIOSCIENCES, INC. A Member of the UCB Group of Companies

Ethics review

Status: Approved
Approval date:
Contact: