E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10065336 |
E.1.2 | Term | Partial epilepsy |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the long-term safety and tolerability of brivaracetam at individualized doses with a maximum of 150 mg/day in subjects suffering from epilepsy. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the maintenance of efficacy over time of brivaracetam. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. In Germany all subjects must be older than 18 years. 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. |
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E.4 | Principal 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 study of another investigation drug or device during the trial. Pregnant or lactating woman. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Efficacy Variables The percent (%) reduction from baseline for seizure frequency per week for POS (type I) over the Evaluation Period (V1 until the last evaluation visit). It will be derived from the seizure count information recorded on the DRC and is defined as the number of epileptic seizures standardized to a seven day period. The percent (%) reduction from baseline for seizure frequency per week for all epileptic seizures (types I+II+III) over the Evaluation Period. The absolute reduction from baseline for seizure frequency per week for POS (type I) over the Evaluation Period (V1 until the last evaluation visit). The absolute reduction from baseline for seizure frequency per week for all epileptic seizures (types I+II+III) over the Evaluation Period Continuously epileptic seizure free subjects for all epileptic seizures types (I+II+III) over the Evaluation Period. Responder rate in partial onset seizures (type I) over the Evaluation period. A responder for type I seizures is defined as a subject with a ≥ 50% reduction in seizure frequency per week from the baseline. Cumulative proportion of subjects remaining on BRV monotherapy. Exploratory Efficacy Variables QOLIE-31-P scores at Full Evaluation Visit, at Yearly Evaluation Visit and/or at Early Discontinuation Visit. HADS scores at Full Evaluation Visit, at Yearly Evaluation Visit and/or at Early Discontinuation Visit. EQ-5D questionnaire at Full Evaluation Visit, at Yearly Evaluation Visit and/or at Early Discontinuation Visit. Medical resources used by 3-month periods over the Evaluation Period. Number of working or school days lost by the subject and days subject received help from a caregiver (paid or not) at home by 3-month periods over the Evaluation period. Socio-professional data at Yearly Evaluation Visit and/or at Early Discontinuation Visit and Final Visit. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 60 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |