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

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ClinicalTrials.gov Identifier: NCT05958160
Recruitment Status : Recruiting
First Posted : July 24, 2023
Last Update Posted : July 24, 2023
Sponsor:
Information provided by (Responsible Party):
Suvasini Sharma, Lady Hardinge Medical College

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Epileptic Spasms, Failed Hormonal Therapy Other: Modified Atkins diet Drug: Topiramate Phase 2 Phase 3

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Open-label study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Modified Atkins Diet Versus Topiramate In Children With Epileptic Spasms Refractory To Hormonal Treatment: A Randomized Open-Label Study
Estimated Study Start Date : July 20, 2023
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : October 31, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Topiramate

Arms and Interventions
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Arm Intervention/treatment
Experimental: Modified Atkins Diet Arm
Modified Atkins diet will be added to the ongoing anti-seizure medication regimen
 Other: Modified Atkins diet
The modified Atkins diet is a less restrictive version of the ketogenic diet
Other Name: Ketogenic diet
Active Comparator: Topiramate arm
Topiramate will be added to the ongoing anti-seizure medication regimen
 Drug: Topiramate
Topiramate is an anti-seizure medication


Outcome Measures
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Primary Outcome Measures :
  1. 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 ≥ 50% reduction in clinical spasms at 12 weeks as compared to baseline as per parental reports in both groups


Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Adverse effects of the intervention in both groups [ Time Frame: 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   9 Months to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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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

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Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05958160


Contacts
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Contact: Suvasini Sharma, MD, DM 9910234344 ext 0091 sharma.suvasini@gmail.com
Contact: Sharmila B Mukherjee, MD 9818158699 ext 0091 theshormi@gmail.com

Locations
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India
Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital Recruiting
New Delhi, Delhi, India, 110001
Contact: Suvasini Sharma, DM       sharma.suvasini@gmail.com   
Sub-Investigator: Suvasini Sharma, DM         
Sponsors and Collaborators
Lady Hardinge Medical College
Investigators
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Principal Investigator: Suvasini Sharma, MD, DM Lady Hardinge Medical College
More Information
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Responsible Party: Suvasini Sharma, Professor, Lady Hardinge Medical College
ClinicalTrials.gov Identifier: NCT05958160    
Other Study ID Numbers: TOPAMAD
First Posted: July 24, 2023    Key Record Dates
Last Update Posted: July 24, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Epilepsy
Spasm
Spasms, Infantile
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Manifestations
 Neurologic Manifestations
Epilepsy, Generalized
Epileptic Syndromes
Topiramate
Anticonvulsants
Hypoglycemic Agents
Physiological Effects of Drugs