Ketogenic Diet vs ACTH for the Treatment of Children With West Syndrome

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: All India Institute of Medical Sciences, New Delhi

Criteria

Inclusion Criteria:

• Children, aged 6 month - 2 years with electroclinical diagnosis of west syndrome

Exclusion Criteria:

• Already on ACTH, prednisolone vigabatrin or KD therapy > 5days

• Tuberous sclerosis

• Vitamin trial responsiveness

• Known Pre-existing contraindications for KD (IEM, Porphyria etc.)

• Chronic systemic illness (Ex: Chronic kidney disease, congenital heart diseases etc)