Comparing Modified Atkins Diet and Topiramate for Children with Refractory Epileptic Spasms
Modified Atkins Diet Versus Topiramate In Children With Epileptic Spasms Refractory To Hormonal Treatment: A Randomized Open-Label Study
This study is testing whether a special diet or a medication works better for young children with tough-to-treat epileptic spasms.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 9 Months to 3 Years |
| Sex | All |
| Sponsor | Lady Hardinge Medical College Government |
| Locations | 1 site (New Delhi, Delhi) |
| Trial ID | NCT05958160 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness and tolerability of the modified Atkins diet compared to topiramate in children aged 9 months to 3 years who have infantile epileptic spasms that have not responded to hormonal treatments. The research is designed as a randomized open-label trial, focusing on children diagnosed with this severe epilepsy syndrome. The modified Atkins diet is a less restrictive alternative to the ketogenic diet, which has shown promise in treating intractable epilepsy. The study will assess the outcomes over a specified period to determine which intervention provides better results for these young patients.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 9 months to 3 years diagnosed with infantile epileptic spasms syndrome who have failed hormonal therapy.
Not a fit: Patients with known metabolic disorders, prior use of the ketogenic or modified Atkins diet, or significant systemic illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new dietary treatment option for children with refractory epileptic spasms, potentially reducing reliance on medications with significant side effects.
How similar studies have performed: Previous studies have shown success with dietary interventions like the modified Atkins diet in treating similar conditions, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 -
Where this trial is running
New Delhi, Delhi
- Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital — New Delhi, Delhi, India (Recruiting)
Study contacts
- Principal investigator: Suvasini Sharma, MD, DM — Lady Hardinge Medical College
- Study coordinator: Suvasini Sharma, MD, DM
- Email: sharma.suvasini@gmail.com
- Phone: 9910234344
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.