An open-label, multinational, multicenter, follow-up study to evaluate the long-term safety and efficacy of brivaracetam, used at a flexible dose up to a maximum of 200 mg/day, in subjects aged 16 years or older suffering from epilepsy.

• Register: EUCTR
• Last refreshed on: 26 February 2018
• Main ID: EUCTR2008-001433-98-BE
• Date of registration: 19/06/2008
• Prospective Registration: Yes
• Primary sponsor: UCB BioSciences, Inc
• Public title: An open-label, multinational, multicenter, follow-up study to evaluate the long-term safety and efficacy of brivaracetam, used at a flexible dose up to a maximum of 200 mg/day, in subjects aged 16 years or older suffering from epilepsy.
• Scientific title: An open-label, multinational, multicenter, follow-up study to evaluate the long-term safety and efficacy of brivaracetam, used at a flexible dose up to a maximum of 200 mg/day, in subjects aged 16 years or older suffering from epilepsy.
• Date of first enrolment: 11/08/2008
• Target sample size: 600
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-001433-98
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other: 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

Australia, Belgium, Canada, Czech Republic, Finland, France, Germany, Hungary, Italy, Spain, Sweden, 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 IEC/IRB approved 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.
• Male/female subjects from 16 years or older. Subjects under 18 years may only be included where legally permitted and ethically accepted.
• Subjects with epilepsy who participated in previous brivaracetam trials which allow access to the present trial.
• Subjects from whom the Investigator believes a reasonable potential benefit from the long-term administration of brivaracetam may be expected.
• Female subjects without childbearing potential (premenarcheal; 2 years postmenopausal bilateral oophorectomy or ovariectomy, bilateral salpingectomy, complete hysterectomy, congenital sterility) are eligible. Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method for the duration of the trial (Intra Uterine Device, diaphragm with spermicide, male or female condom with spermicide; oral hormonal contraceptive, non-oral hormonal contraceptive medication, bilateral tubal ligation, bilateral tubal implant, monogamous relationship with vasectomized partner). Oral or depot contraceptive treatment with at least 30 µg [or 50 µg if associated with other antiepileptic drugs known as inducers] ethinylestradiol per intake must be used in conjunction with a barrier method. 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. Sexual inactivity might be accepted on a case-by-case basis.
• Subject/legally acceptable representative considered as reliable and capable of adhering to the protocol (e.g. 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 4
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion criteria:
• Severe medical, neurological and psychiatric disorders, including current suicidal ideation or behaviour, or laboratory values which may have an impact on the safety of the subject, as determined by the investigator.
• Poor compliance with the visit schedule or medication intake in the previous brivaracetam trial.
• Participation in any clinical trial of another investigation drug or device during the trial.
• Pregnant or lactating woman.


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

Health Condition(s) or Problem(s) studied

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

Epilepsy
MedDRA version: 18.0 Level: PT Classification code 10015037 Term: Epilepsy System Organ Class: 10029205 - Nervous system disorders

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-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: At the conclusion of the study.

Primary end point(s): To evaluate the long-term safety and tolerability of brivaracetam at
individualized doses with a maximum of 200 mg/day in subjects
suffering from epilepsy

Secondary Objective: • To evaluate the maintenance of efficacy over time of brivaracetam.
• To explore impact on health-related quality of life, anxiety and depression.
• To obtain a description of patient’s self-reported health status.
• To collect data on medical resources used and on indirect costs parameters.

Main Objective: To evaluate the long-term safety and tolerability of brivaracetam at individualized doses with a maximum of 200 mg/day in subjects suffering from epilepsy.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: At the conclusion of the study.

Secondary end point(s): To evaluate the maintenance of efficacy over time of brivaracetam.

Secondary ID(s)

N01315

NCT00761774

Source(s) of Monetary Support

UCB BioSciences, Inc