Health Condition 1: G408- Other epilepsy and recurrent seizures
Conditions
Interventions
Intervention1: Prednisolone: Prednisolone is started at 2 mg/kg/day for 2 weeks and tapered over next tapered over next 10 weeks. Children are monitored for any adverse effect of drug during this peri
Sponsors
Child Neurology Division, AIIMS New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: Children diagnosed with LGS as per ILAE 2017 definition with Age 3-12 years Have failed at least 4 ASMs with adequate dose and duration Experiences more than four seizures per month with at least 1 seizure per week On a stable antiseizure drug regime On a stable ketogenic diet ratio, if diet is ongoing.
Exclusion criteria
Exclusion criteria: Primary Exclusion Criteria 1.Has a diagnosed progressive neurodegenerative or neurometabolic disorder 2.Has history of recurrent infections (one per month) requiring hospitalization in the past three months before enrollment. 3.Had a history of febrile illness within last 15 days before enrollment 4.Is a candidate for epilepsy surgery and parents willing to undergo the same. 5.Has received steroids in the past for more than two weeks as treatment for LGS 6.Is on treatment for any other (already diagnosed) chronic health condition which may worsen with steroid therapy. Secondary exclusion criteria To be applied after the four week observation phase 1.Occurrence of any febrile illness lasting more than 24 hours 2.Change in ASMs (use of abortive therapy with benzodiazepine is allowed) 3.Chest X-ray or Mantoux test suggestive of Tuberculosis 4.Seizure frequency less than 1 seizure per week.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To compare the proportion of children (3 to 12 years) with Lennox Gastaut Syndrome (LGS) who develop more than 50 percent reduction in seizures between intervention arm (oral prednisolone + Antiseizure medications (ASMs)) and control arm (Standard ASMs alone) at 12 weeks (and 7 days) of therapyTimepoint: 1.To compare the proportion of children (3 to 12 years) with Lennox Gastaut Syndrome (LGS) who develop more than 50 percent reduction in seizures between intervention arm (oral prednisolone + Antiseizure medications (ASMs)) and control arm (Standard ASMs alone) at 12 weeks (and 7 days) of therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To compare the proportion of children with LGS who develop more than 5 point improvement in T-score in any behavioral domain of Childhood behavior checklist (CBCL) between intervention arm (oral prednisolone + ASMs) and control arm (Standard ASMs alone) at 12 weeks (7 days) of therapy. 2.To compare the mean change in PINACLE score from baseline at 12 weeks (7 days) of therapy between intervention arm and control arm. 3.To compare the mean change in serum interleukin 6 levels pre and post treatment in intervention arm and control arm. 4.To compare the proportion of children with LGS who develop more than 50 percent reduction in seizures both in intervention arm (oral prednisolone along with ASMs) and control arm (Standard ASMs) at 24 weeks and 7 days (12 weeks post stopping prednisolone) 5.To evaluate the adverse effect profile of prednisolone in children with LGS Timepoint: 24 weeks and 7 days | — |
Countries
India
Contacts
Public ContactDr Taniya Mate
AIIMS New Delhi
Outcome results
None listed