Partial Onset Seizures MedDRA version: 9.1 Level: LLT Classification code 10015037 Term: Epilepsy
Conditions
Sponsors
UCB Pharma S.A.
Eligibility
Sex/Gender
All
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 generalizedn(Type I seizures according to the ILAE classification). • 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). Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
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 |
|---|---|
| Main Objective: To evaluate the efficacy of brivaracetam (BRV) at the doses of 20, 50 and 100 mg/day in b.i.d. administration in reducing seizure frequency in subjects with partial onset seizures not fully controlled despite optimal treatment with 1 to 2 concomitant AED(s), compared to placebo.;Secondary Objective: - To confirm the dose/clinical response relationship - To assess the effects of BRV on Type 1C seizures - To assess the safety and tolerability of BRV - To assess the effects BRV on patients' Health-Related Quality of Life (HRQoL) - To obtain a description of the patients' self-reported health status - To explore direct medical resources use and indirect cost parameters - To explore the population pharmacokinetics of BRV and identify relevant covariates and to assess the impact of BRV on concomitant AED plasma-levels - To collect blood samples for genotyping of SV2-and epilepsy-related genes;Primary end point(s): Primary Efficacy Variable The primary efficacy variable is the partial onset seizure (Type I) frequency per week over the Treatment Period. Secondary Efficacy Variables • 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 the 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 frequenc | — |
Countries
Belgium, Finland, France, Germany, Hungary, Italy, Netherlands, Spain, United Kingdom
Outcome results
None listed