Follow-up trial to evaluate Long-Term safety and efficacy of brivaracetam in subjects suffering from epilepsy

• Register: EUCTR
• Last refreshed on: 25 November 2019
• Main ID: EUCTR2004-002140-10-BE
• Date of registration: 30/06/2005
• Prospective Registration: Yes
• Primary sponsor: UCB Pharma S.A.
• Public title: Follow-up trial to evaluate Long-Term safety and efficacy of brivaracetam in subjects suffering from epilepsy
• Scientific title: An open-label, multi-center, follow-up trial to evaluate long-term safety and efficacy of brivaracetam (ucb 34714) used as adjunctive treatment 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: 24/08/2005
• Target sample size: 1000
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-002140-10
• 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

Austria, Belgium, Canada, Czech Republic, Finland, Germany, Hong Kong, Hungary, Italy, Korea, Republic of, Russian Federation, Serbia, Singapore, South Africa, Spain, Sweden, Taiwan, Tunisia, 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 IEC/IRB approved written informed consent signed and dated by the subject or legally acceptable representative(s). The consent form or a specific assent form will be signed and dated by minors, according to country-specific regulations.
•Male/female subjects from 16 years or older. Subjects under 18 years may only be included where legally permitted and ethically accepted.
•Subjects with POS/PGS: inpatients or outpatients with epilepsy who participated in previous brivaracetam studies / programs which allow access to the present study. Subjects with ULD: inpatients or outpatients with epilepsy who were treated with brivaracetam in previous studies / programs which allow access to the present study.
•Subjects for whom the Investigator believes a reasonable benefit from the long-term administration of brivaracetam may be expected.
•Female subjects with childbearing potential:
o POS/PGS subjects: 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 study participation (Intra Uterine Device; diaphragm with spermicide; male or female condom with spermicide; oral hormonal contraceptive; non-oral hormonal contraceptive medication; bilateral tubal ligation; monogamous relationship with vasectomized partner). In particular, oral or depot contraceptive treatment with at least 30 µg [or 50 µg if associated with carbamazepine (CBZ) or other strong enzyme inducing drugs] 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 according to the judgment of the Investigator.
o ULD subjects: Female ULD subjects without childbearing potential (premenarcheal, 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 30 µg [or 50 µg ethinylestradiol per intake if associated with carbamazepine (or other strong enzyme inducers e.g. phenobarbital, primidone, oxcarbazepine)] must be used in conjunction with a barrier method. 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. 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 (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 Numb
Exclusion criteria:
•Severe medical, neurological and psychiatric disorders, or laboratory values which may have an impact on the safety of the subject.
•Poor compliance with visit schedule or medication intake in previous brivaracetam trial.
•Participation in any clinical trial of another investigational drug or device during the study.
•Pregnant or lactating woman.

If the Investigator has any medically valid reason to doubt the eligibility of a subject, the subject should not be included into the trial. If however, the Investigator has any other kind of doubts concerning the eligibility, he/she should consult the Sponsor’s Clinical Study Physician or representative for clarification.


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

Health Condition(s) or Problem(s) studied

Epilepsy
MedDRA version: 18.0 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-

Primary Outcome(s)

Secondary Objective: Secondary objective :
• To evaluate the maintenance of efficacy over time of brivaracetam (for POS/PGS subjects).

Exploratory objectives for POS/PGS subjects:
• To explore direct medical resource use and indirect cost parameters for the first 2 years
• To obtain a description of the subject’s self-reported health status for the first 2 years
• To explore the effects of BRV on the subject’s Health-related Quality of Life, anxiety,
and depression for the first 2 years
• To explore any change in the subject’s socio-professional status for the first 2 years

No exploratory objectives are defined for ULD subjects or N01315 subjects.

Primary end point(s): Primary safety variables: Occurrence of a TEAE; Withdrawal due to AE; Occurrence of an SAE.

Other safety variables: laboratory tests (including blood and urine), ECG, physical and neurological examinations, vital signs, body weight and change in HADS scores.

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.

Timepoint(s) of evaluation of this end point: Primary Safety Variables: during the evaluation period of the study.

Change in HADS scores:
o From the Baseline of the previous study to each assessment for the first 2 years
o To the last Evaluation Period assessment during the first 2 years

Secondary Outcome(s)

Secondary end point(s): Secondary efficacy variables
For subjects with focal-onset epilepsy:
o Partial onset seizure (type I) frequency per 28 days during the Evaluation Period.
o Percent reduction in POS (type I) frequency per 28 days from Baseline of the previous study to the Evaluation Period.
o Responder rate for 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 or subjects with ULD or coming from N01315.

Timepoint(s) of evaluation of this end point: During the evaluation period of the study.

Secondary ID(s)

N01125

NCT00175916

Source(s) of Monetary Support

UCB Pharma S.A.

Ethics review

Status: Approved
Approval date:
Contact: