refractory epilepsy with partial-onset seizures in children aged from 1 month to < 2 years MedDRA version: 21.1 Level: LLT Classification code 10065336 Term: Partial epilepsy System Organ Class: 100000004852
Conditions
Sponsors
BIAL - Portela & Ca, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Have an informed consent signed by their parent(s) or guardian(s) before undergoing any study-related activities. - Current treatment with 1 to 2 anti-epileptic drugs (except oxcarbazepine; vagus nerve stimulation if present and functioning will not be counted as an anti-epileptic drug). - Have completed the Evaluation Period in Study 211. Are the trial subjects under 18? yes Number of subjects for this age range: 24 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Diagnosis of treatable seizure aetiology such as metabolic, toxic, and infectious disorders. - Primarily generalised seizures. - Known rapidly progressive neurological disorders (e.g. rapidly progressive brain disease, epilepsy secondary to rapidly progressive cerebral lesion). - Seizures of non-epileptic origin. - Diagnosis with Epileptiform Encephalopathies (Early Myoclonic Encephalopathy, Ohtahara syndrome, West syndrome [current], Dravet’s syndrome, or Lennox-Gastaut syndrome). - Uncontrolled cardiac (including atrioventricular block and other clinically significant electrocardiographic abnormalities), renal, hepatic, endocrine, gastrointestinal, metabolic, haematological, or oncology disorders. - Hypersensitivity to the active substance, to other carboxamide derivatives (e.g. carbamazepine, oxcarbazepine), or to any of the excipients, in particular methyl parahydroxybenzoate (E218) or sulphites. - Relevant clinical laboratory abnormalities (e.g. sodium 2 x the upper limit of normal, white blood cell count <3000 cells/mm3) (measured at Visit 1). - Any other condition or circumstance that, in the opinion of the investigator, could compromise the subject’s ability to comply with the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and tolerability of 1 year of treatment with ESL in the defined patient population and to perform exploratory analyses of efficacy.;Secondary Objective: Not applicable;Primary end point(s): Efficacy: • Seizures (date, time, type, and duration) recorded by the parent(s) or guardian(s) in study diaries. Safety: • Treatment-emergent adverse events (TEAEs) defined as all AEs with onset or worsening after first intake of study treatment until 4 weeks after last intake of study treatment. • Clinical laboratory safety tests: - Biochemistry: sodium, potassium, calcium, creatinine, blood urea nitrogen, aspartate transaminase, alanine transaminase, gamma-glutamyl transferase, albumin, total protein, total bilirubin, and glucose. - Haematology: haemoglobin, haematocrit, erythrocyte count, leucocyte count with differential, and platelet count. • Urinalysis: local dipstick test of pH, specific gravity, protein, blood, glucose, ketones, bilirubin, and urobilinogen. If dipstick results indicate a significant abnormality, then microscopy and other appropriate tests (as needed) will be performed by the central laboratory. • Physical examination, vital signs, neurological examination, and electrocardiogram.;Timepoint(s) of evaluation of this end point: Ath the end of the Trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Croatia, Czechia, Czech Republic, Italy, Portugal, Romania, Russian Federation, Serbia, Ukraine
Contacts
Public ContactSponsor
BIAL - Portela & Ca, S.A.
Outcome results
None listed