Health Condition 1: - Health Condition 2: G408- Other epilepsy and recurrent seizures
Conditions
Interventions
Intervention1: Group 1 :Modified Atkins Diet
Group 2: Topiramate: Group 1: Modified Atkins Diet: Low carbohydrate, fat soluble multivitamins and calcium supplementation prescribed
Group 2: Topiramate
Sponsors
Lady hardinge medical college and Associated hospitals
Eligibility
Inclusion criteria
Inclusion criteria: 1)Diagnosis of infantile epileptic spasms syndrome as per the ILAE 2022 diagnostic criteria. 2)Failure of hormonal therapy, i.e. oral prednisolone or ACTH.
Exclusion criteria
Exclusion criteria: 1) Known or suspected inborn error of metabolism 2) Prior use of the ketogenic or modified Atkins diet or Topiramate 3) Systemic illness- chronic hepatic, renal or pulmonary disease 4) Diagnosed renal stones
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of children with equal to or more than 50% reduction in clinical spasms at 12 weeks as compared to baseline as per parental reports in both groupsTimepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) The proportion of children with clinical spasm cessation as per parental reports at the end of 12 weeks of treatment in both groups 2) The proportion of children with equal & more than 1 point improvement in BASED score at 12 week as compared to baseline in both groups 3) Adverse effects of the intervention in both groups 4) Proportion of patients withdrawing from both the groups and reasons for withdrawal 5) Proportion of patients with improvement in non-seizure domains like alertness, activity level, speech or communication, comprehension or understanding, sleeping, motor skills, social interaction and behaviour, as assessed by parental reports on Likert scale in both groupsTimepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactDr Sharmila B Mukherjee
Lady hardinge Medical College and Associated Hospitals.
Outcome results
None listed