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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

Tracking Information
First Submitted Date  ICMJE July 14, 2023
First Posted Date  ICMJE July 24, 2023
Last Update Posted Date July 24, 2023
Estimated Study Start Date  ICMJE July 20, 2023
Estimated Primary Completion Date September 30, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2023)		 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2023)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Modified Atkins Diet Versus Topiramate In Children With Epileptic Spasms Refractory To Hormonal Treatment: A Randomized Open-Label Study
Official Title  ICMJE Modified Atkins Diet Versus Topiramate In Children With Epileptic Spasms Refractory To Hormonal Treatment: A Randomized Open-Label Study
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized Open-label study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Epileptic Spasms, Failed Hormonal Therapy
Intervention  ICMJE
  • Other: Modified Atkins diet
    The modified Atkins diet is a less restrictive version of the ketogenic diet
    Other Name: Ketogenic diet
  • Drug: Topiramate
    Topiramate is an anti-seizure medication
Study Arms  ICMJE
  • Experimental: Modified Atkins Diet Arm
    Modified Atkins diet will be added to the ongoing anti-seizure medication regimen
    Intervention: Other: Modified Atkins diet
  • Active Comparator: Topiramate arm
    Topiramate will be added to the ongoing anti-seizure medication regimen
    Intervention: Drug: Topiramate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 14, 2023)		 70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2024
Estimated Primary Completion Date September 30, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

-
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 9 Months to 3 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Suvasini Sharma, MD, DM 9910234344 ext 0091 sharma.suvasini@gmail.com
Contact: Sharmila B Mukherjee, MD 9818158699 ext 0091 theshormi@gmail.com
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05958160
Other Study ID Numbers  ICMJE TOPAMAD
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Suvasini Sharma, Lady Hardinge Medical College
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Lady Hardinge Medical College
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Suvasini Sharma, MD, DM Lady Hardinge Medical College
PRS Account Lady Hardinge Medical College
Verification Date July 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP