UnknownPhase 2/3

Modified Atkins Diet Versus Topiramate In Children With Epileptic Spasms Refractory To Hormonal Treatment: A Randomized Open-Label Study

India70 participantsStarted 2023-07-20

Plain-language summary

This study has been planned to compare the efficacy and tolerability of topiramate, a commonly used second line agent, with modified Atkins diet in children with epileptic spasms refractory to hormonal treatment, in a randomized open label study.

Who can participate

Age range9 Months – 3 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: 1\) Age: 9 months to 3 years 2) Diagnosis of infantile epileptic spasms syndrome as per the ILAE 2022 diagnostic criteria 3) Failure of hormonal therapy, i.e. oral prednisolone or ACTH \- 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 \-

What they're measuring

The proportion of children with ≥ 50% reduction in clinical spasms at 12 weeks as compared to baseline as per parental reports in both groups

Timeframe: 12 weeks

Trial details

NCT IDNCT05958160

SponsorLady Hardinge Medical College

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2024-09-30

Contact for this trial

Suvasini Sharma, MD, DM

9910234344 sharma.suvasini@gmail.com

View on ClinicalTrials.gov More Epileptic Spasms, Failed Hormonal Therapy trials