Health Condition 1: G404- Other generalized epilepsy and epileptic syndromes
Conditions
Interventions
Intervention1: Vigabatrin drug: Vigabatrin will be given in a dose of 25mg/kg in divided doses in first week and followed by 50mg/kg(max 4mg/day). thereafter dose will be maintained till 12 weeks
Cont
Sponsors
Dr Jayantee Kalita Principal Investigator
Eligibility
Inclusion criteria
Inclusion criteria: Children aged 2 to 18 years having LGS who are using 2-5 antiepileptic drugs (AED) for 1month will be eligible for enrolment.
Exclusion criteria
Exclusion criteria: Progressive cognitive or neurological deficit, known degenerative neurological disease or metabolic disease,hemi-clonic seizures in the first year of life, only clusters of drop seizure, visual loss, hepatic disease, and if concomitant ketogenic diet, cannabidiol, fenfluramine use at the time of enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary end point will be the percentage change from baseline in drop attacks. A more than 50% reduction in drop attack will be considered improved.Timepoint: Outcome will be defined at 3 months and sequential assessment will be done every 4 weeks interval. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary end points will be the percentage change from baseline in frequency of different types of seizures, 50% or greater responder rate in seizures, number of seizure free days, number of midazolam nasal spray needed and proportion of patients who achieved improvement (minimally, much, or very much improved) on the Clinical Global Impression-Improvement (CGI-I) scale in both the groups. Additional secondary outcomes are improvement in EEG and adverse events.Timepoint: Outcome will be defined at 3 months and sequential assessment will be done every 4 weeks interval. | — |
Countries
India
Contacts
Public ContactDr Jayantee Kalita
SGPGIMS
Outcome results
None listed