Status:
ACTIVE_NOT_RECRUITING
Ketogenic Diet vs ACTH for the Treatment of Children With West Syndrome
Lead Sponsor:
All India Institute of Medical Sciences
Conditions:
Ketogenic Diet
West Syndrome
Eligibility:
All Genders
6-2 years
Phase:
PHASE2
PHASE3
Brief 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 hi...
Detailed Description
* Consecutive children with West Syndrome (clinical spasm with EEG correlate) will be screened in the study centre for eligibility, and after applying inclusion and exclusion criteria they will be wor...
Eligibility Criteria
Inclusion
- Children, aged 6 month - 2 years with electroclinical diagnosis of west syndrome
Exclusion
- 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)
Key Trial Info
Start Date :
April 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 28 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05279118
Start Date
April 18 2022
End Date
July 28 2024
Last Update
June 25 2024
Active Locations (2)
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1
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India, 110029
2
AIIMS
New Delhi, India, 110049