Ketogenic Diet vs ACTH for the Treatment of Children With West Syndrome
Status:
Not yet recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
Summary
Children with West syndrome are prone to refractory seizures with poor neurocognitive outcome
overall. The current standard of care consists of treatment with ACTH, but the grade of
evidence is not high and not much RCTs are available. Ketogenic diet is an effective and well
tolerated treatment option in drug refractory epilepsy and also in refractory west syndrome.
In view of minimal side effects, better cost parameters and ability to continue for a longer
duration our study aiims to investigate the efficacy of ketogenic diet as a first line
therapy in comparison to ACTH therapy. Children with west syndrome after satisfying the
inclusion and exclusion criteria will be randomised into the two treatment arms and primary
response will be noted at the end of 6 weeks of therapy in terms of mean percentage of spasm
reduction.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
All India Institute of Medical Sciences, New Delhi