Localization-related or generalized epilepsy MedDRA version: 9.1 Level: LLT Classification code 10015037 Term: Epilepsy
Conditions
Sponsors
UCB Pharma
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. • Subjects with well-characterized localization-related epilepsy or generalized epilepsy according to the ILAE classification (1). • For subjects suffering from: • localization-related epilepsy (1): subjects having at least 2 partial onset seizures whether or not secondarily generalized per month during the 3 months preceding V1 according to ILAE classification (2). • generalized epilepsy (1): subjects having at least 2 Type II seizure days per month during the 3 months preceding V1 according to the ILAE classification (2). • For subjects suffering from: • localization-related epilepsy (1): subjects having at least 4 partial onset seizures whether or not secondarily generalized during the 4-week Baseline Period according to the ILAE classification (2). • generalized epilepsy (1): subjects having at least 4 Type II seizure days during the 4-week Baseline Period according to the ILAE classification (2). • Subjects being uncontrolled while treated by 1 to 3 permitted concomitant AED(s). Vagal Nerve Stimulation (VNS) is allowed and will not be counted as a concomitant AED. • Permitted concomitant AED(s) and VNS (implanted for at least 9 months) being stable and at optimal dosage for the subject from at least 1 month (3 months for phenobarbital and primidone) before V1 and expected to be kept stable during the Treatment Period. Benzodiazepine (BZD) taken more than once a week (for any indication) will be considered as a concomitant AED. 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: • Subjects suffering from epilepsies and syndromes undetermined whether focal or generalized (classification 3 according to the ILAE classification (1)). • Subjects suffering from special syndromes (classification 4 according to the ILAE classification (1)). • For subjects suffering from localization-related epilepsy (1): history or presence of seizures occurring only in clusters (too frequently or indistinctly separated to be reliably counted) before V2. • History or presence of status epilepticus during the year preceding V1 or during Baseline. • History or presence of known pseudo-seizures. • Subjects taking any drug with possible CNS effects except if stable from at least 1 month before V1 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 1 month before V1, and is expected to be kept stable during the Treatment Period. • History of cerebrovascular accident (CVA), including transient ischemic attack (TIA), within the last 6 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 assess the safety and tolerability of BRV at the dose range from 20 to 150 mg/day in b.i.d. administration in subjects suffering from localization-related or generalized epilepsy not fully controlled despite optimal treatment with 1 to 3 concomitant AED(s), compared to placebo (PBO).;Secondary Objective: •To confirm the efficacy of BRV in reducing partial onset seizure (Type I) frequency in subjects suffering from localization-related epilepsy. • To assess the effects of BRV on patients’ Health-Related Quality of Life (HRQoL) in subjects suffering from localization-related epilepsy. • To assess the effects of BRV on Type IC seizures. Exploratory Efficacy Objectives • To obtain a description of the patient’s self-reported health status. • To explore direct medical resources use and indirect cost parameters. • To collect blood samples for genotyping of SV2-and epilepsy-related genes (for a pooled analysis at the program level). • To explore the efficacy of BRV in reducing Type II seizure days in subjects suffering from generalized epilepsy. • To explore the effects of BRV on patients’ Health-Related Quality of Life (HRQoL) in subjects suffering from generalized epilepsy.;Primary end point(s): The primary efficacy variable is the partial onset seizure (Type I) frequency per week over the Treatment Period (Dose-finding Period + Maintenance Period) in subjects suffering from localization-related epilepsy. Safety Variables • Adverse events reporting. • Laboratory tests (including blood chemistry, hematology and urinalysis). • AED and BRV plasma levels. • Electrocardiogram (ECG). • Physical and neurological examinations. • Vital signs including orthostatic measurements. • Body weight. | — |
Countries
Austria, Belgium, Czech Republic, Germany, Italy, Sweden
Outcome results
None listed