A Phase 2/3 interventional study of Modified Atkins diet and Topiramate in Epileptic Spasms, Failed Hormonal Therapy, sponsored by Lady Hardinge Medical College. Recruiting at 1 site in India. Open to participants aged 9 Months to 3 Years. Per ClinicalTrials.gov, last updated 2023-07-24.
Sponsored by Lady Hardinge Medical College · Phase 2/3, Interventional, and Treatment
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.
Infantile epileptic spasms syndrome, formerly known as West syndrome is a severe and difficult to treat epilepsy syndrome in infants and young children. The first-line options of this condition include hormonal therapy, i.e., adrenocorticotropic hormone (ACTH) or oral corticosteroids, and/or vigabatrin. These are effective in 45%-55% of the patients. These are however associated with significant side effects, and high relapse rates. Newer drugs such as topiramate, zonisamide, and levetiracetam have also been evaluated; but there have been no randomized trials to evaluate the efficacy of these agents. Topiramate is one of the most commonly used second line agents used for the treatment of epileptic spasms.
The ketogenic diet (KD), a high-fat, low-carbohydrate, adequate-protein diet is an established, effective non-pharmacologic treatment for children with intractable epilepsy. Despite being highly efficacious, ketogenic diet has practical constraints in implementation leading to need for alternative approaches. The modified Atkins diet is a less restrictive variation of the ketogenic diet. This diet is more palatable and acceptable in comparison to ketogenic diet. The modified Atkins diet has shown to be effective in children with epileptic spasms refractory to first line treatment in a recent randomized controlled trial, comparing add-on diet versus continuing the on-going anti-seizure medications alone. At the end of 4 weeks, 11 children in the diet group were spasm free compared with none in the control group (P ≤ .001).
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. The results will guide clinicians as to the best options in children with epileptic spasms refractory to hormonal treatment.
47 studies on the registry are indexed under Spasms, Infantile; 8 are open to participants now.
This study's planned enrollment of 70 is above the median of 40 across 33 interventional studies indexed under Spasms, Infantile.
Browse Spasms, Infantile studies →Lady Hardinge Medical College is the lead sponsor of 34 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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Modified Atkins diet will be added to the ongoing anti-seizure medication regimen
Other: Modified Atkins diet
Topiramate will be added to the ongoing anti-seizure medication regimen
Drug: Topiramate
The modified Atkins diet is a less restrictive version of the ketogenic diet
Also known as: Ketogenic diet
Topiramate is an anti-seizure medication
The proportion of children with ≥ 50% reduction in clinical spasms at 12 weeks as compared to baseline as per parental reports in both groups
The proportion of children with ≥ 50% reduction in clinical spasms at 12 weeks as compared to baseline as per parental reports in both groups
Time frame: 12 weeks
The proportion of children with clinical spasm cessation as per parental reports at the end of 12 weeks of treatment in both groups.
Time frame: 12 weeks
The proportion of children with ≥ 1 point improvement in BASED score at 12 week as compared to baseline in both groups
Time frame: 12 weeks
Adverse effects of the intervention in both groups
Time frame: 12 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Jul 2023; primary completion for Sep 2024, 14 months later.
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