epilepsy
Conditions
Interventions
All subjects will be either randomised to brivaracetam:
- 20 mg/day,
- 50 mg/day,
- 100 mg/day or
- matching placebo.
All subjects will be asked to take 3 tablets in the morning and 3 tablets in
Sponsors
UCB Pharma
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Subjects from 16 to 70 years, both inclusive. Subjects under 18 years may only be included where legally permitted and ethically accepted. • Well-characterized focal epilepsy or epileptic syndrome according to the ILAE classification (1). • Subjects with a history of partial onset seizures whether or not secondarily generalized (Type I seizures according to the ILAE classification (2)). • Subjects having at least two partial onset seizures whether or not secondarily generalized per month during the three months preceding Visit 1 (V1). • Subjects having at least eight partial onset seizures whether or not secondarily generalized during the 8-week Baseline Period. • Subjects being uncontrolled while treated by one to two permitted concomitant AED(s).
Exclusion criteria
Exclusion criteria: • History or presence of seizures occurring only in clusters (too frequently or indistinctly separated to be reliably counted) before V3. • History or presence of status epilepticus during the year preceding V1 or during baseline. • Subject taking any drug with possible relevant CNS effects except if stable from at least 1 month before Visit 1 and expected to be kept stable during the Treatment Period. • Subjects taking any drug that may significantly influence the metabolism of BRV (CYP2C or CYP3A potent inducers/inhibitors) except if the dose has been kept stable at least one month before V1, and is expected to be kept stable during the Treatment Period. • History of cerebrovascular accident (CVA), including transient ischemic attack (TIA), in the last six months. • Presence of any sign (clinical or imaging techniques) suggesting rapidly progressing (i.e. not expected to stay stable during trial participation) brain disorder or brain tumor. Stable arteriovenous malformations, meningiomas or other benign tumors may be acceptable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy variable is the partial onset seizure (Type I) frequency per week over the Treatment Period. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Seizure Worry QOLIE-31-P score. • Daily Activities QOLIE-31-P score. • Total QOLIE-31-P score. • Remaining QOLIE-31-P domain scores (Energy/Fatigue, Emotional Well-being, Mental Activity/Cognitive Functioning, Overall Quality of Life and Medication effects). • Hospital Anxiety and Depression Scale (HADS) scores (Anxiety, Depression). • Patient*s Global Evaluation Scale (GES). • Investigator*s GES. • All seizure frequency (Type I + II + III) per week over the Treatment Period. • Seizure freedom rate (all seizure types). • Percent reduction for partial onset seizure (Type I) frequency per week from baseline to the Treatment Period. • Responder rate (the proportion of subjects who have a >= 50% reduction in seizure frequency per week from baseline) for partial onset seizures (Type I) over the Treatment Period. • Categorized percentage reduction from baseline in seizure frequency for partial onset seizures (type I) over the Treatment Period. The categories include: | — |
Countries
Netherlands
Outcome results
None listed