E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Epilepsy (partial seizures with or without secondary generalization) |
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E.1.1.1 | Medical condition in easily understood language |
Epilepsy (partial seizures with or without secondary generalization) |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
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 |
- Evaluate the efficacy of brivaracetam (BRV) compared to placebo (PBO) as adjunctive treatment in subjects (>=16 to 80 years of age) with partial seizures with or without secondary generalization despite current treatment with 1 or 2 concomitant antiepileptic drugs (AEDs) |
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E.2.2 | Secondary objectives of the trial |
- Assess the safety and tolerability of BRV in subjects >=16 years to 80 years of age |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Subjects (male or female) from 16 to 80 years of age at Visit 1, both inclusive - Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method. - Subjects having at least 8 partial seizures (according to the 1981 ILAE classification) during the 8-Week Baseline Period with at least 2 partial seizures during each 4-week interval of the Baseline Period - Subjects having at least 2 partial seizures whether or not secondary generalization per month during the 3 months preceding Visit 1 - Subjects uncontrolled while treated by 1 or 2 permitted concomitant antiepileptic drug [AED](s). Vagal Nerve Stimulation (VNS) is allowed and will be counted as a concomitant AED |
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E.4 | Principal exclusion criteria |
- Subject has history or presence of status epilepticus during the year preceding Visit 1 or during Baseline - Subject is currently treated with levetiracetam - Subject has taken levetiracetam within 90 days prior to Visit 1 |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Incidence of Treatment-Emergent Adverse Events (TEAEs) 2. Incidence of Treatment-Emergent AEs (TEAEs) leading to study withdrawal 3. Incidence of Treatment-Emergent Serious Adverse Events (SAEs) 4. Partial seizure frequency per 28 days during the 12-week Treatment Period |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1.-3. From start of the Treatment Period (Week 2) until Safety Visit (up to Week 18) 4. From Baseline to 12-week Treatment Period |
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E.5.2 | Secondary end point(s) |
1. 50 % responder rate based on percent change in partial seizure frequency per 28 days from Baseline to the 12-week Treatment Period 2. Percent change in partial seizure frequency per 28 days from Baseline to the 12-week Treatment Period 3. Categorized percent change in partial seizures frequency per 28 days from Baseline to the 12-week Treatment Period 4. All seizure frequency (partial, generalized, and unclassified epileptic seizures) per 28 days during the 12-week Treatment Period 5. Seizure freedom (partial, all epileptic seizure) during the 12-week Treatment Period 6. Time to 1st partial seizure during the 12-week Treatment Period 7. Time to 5th partial seizure during the 12-week Treatment Period 8. Time to 10th partial seizure during the 12-week Treatment Period 9. Brivaracetam plasma levels |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1.-3. From Baseline to 12-week Treatment Period 4.-8. During the 12-week Treatment Period 9. Plasma samples will be collected in Week 2, 4, 8, 12, 14 |
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
China |
Japan |
Malaysia |
Philippines |
Singapore |
Taiwan |
Thailand |
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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.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 10 |
E.8.9.2 | In all countries concerned by the trial days | 8 |