OPEN-LABEL, 2-DOSE LEVEL TRIAL TO EVALUATE PHARMACOKINETICS, SAFETY, AND TOLERABILITY OF ESLICARBAZEPINE ACETATE (ESL) AS ADJUNCTIVE THERAPY IN INFANTS WITH REFRACTORY EPILEPSY WITH PARTIAL-ONSET SEIZURES AGED FROM 1 MONTH TO <2 YEARS – 1-YEAR EXTENSIO

BIAL - Portela & Ca, S.A.0 sites24 target enrollmentStarted: February 21, 2017Last updated: June 7, 2021

Conditions

Trial Snapshot

No summary available.

•- 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

•- 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 <130 mmol/L, alanine or aspartate transaminases >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.
•- Estimated glomerular filtration rate below the lower limit of the normal range as shown below for the corresponding age of the subject (measured at Visit 1).
•- Known presence of HLA-A*3101 allele.

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