Health Condition 1: G400- Localization-related (focal) (partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset
Conditions
Interventions
Intervention1: OXC Plus Sodium chloride arm: Oxcarbazepine will be started at a dose of 10 mg/kg/day, will be increased to 15
mg/kg/day after 1 week, and further hiked if a breakthrough seizure occur
Sponsors
All India Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children aged 1-18 years 2. Newly diagnosed with epilepsy (structural/non-structural)
Exclusion criteria
Exclusion criteria: 1. Receiving any other ASM/other medications which interfere with serum sodium and/or body water balance 2. Chronic renal, gastrointestinal, hepatic, pulmonary, cardiac or endocrinal illness 3. IAP grade II or more PEM 4. Baseline hyponatremia/hypernatremia 5. Receiving intravenous fluid at the time of starting oxcarbazepine 6. Anorexia/Bulimia nervosa 7. Caregiver not providing informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of children with hyponatremia (serum sodium less than 135 meq/l) in both armsTimepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in behavioral co-morbidities (measured by CBCL) in both arms Timepoint: 12 weeks;Comparison of the frequency of each adverse event between both arms (CTCAE grading)Timepoint: 12 weeks;Short assessment of patient satisfaction score, clinical global impression-improvement, and efficacy index at the time of discharge in both armsTimepoint: 12 weeks;The change in SQ/IQ (SQ/Full-scale IQ obtained from VSMS/MISIC) of children in both armsTimepoint: 12 weeks;The proportion of children with symptomatic and severe hyponatremia in both armsTimepoint: 12 weeks;The proportion of children with seizure recurrence and requiring polytherapy in 12 weeks after starting oxcarbazepine in both armsTimepoint: 12 weeks;To establish the causality of the adverse event by Naranjo probability score Timepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactDr Neha KC
All India Institute of Medical Sciences, Rishikesh
Outcome results
None listed