NCT05958160

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2023

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

July 20, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 24, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed
Last Updated

July 24, 2023

Status Verified

July 1, 2023

Enrollment Period

1.2 years

First QC Date

July 14, 2023

Last Update Submit

July 14, 2023

Conditions

Epileptic Spasms, Failed Hormonal Therapy

Outcome Measures

Primary Outcomes (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

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

    12 weeks

Secondary Outcomes (3)

  • The proportion of children with clinical spasm cessation as per parental reports at the end of 12 weeks of treatment in both groups.

    12 weeks

  • The proportion of children with ≥ 1 point improvement in BASED score at 12 week as compared to baseline in both groups

    12 weeks

  • Adverse effects of the intervention in both groups

    12 weeks

Study Arms (2)

Modified Atkins Diet Arm

EXPERIMENTAL

Modified Atkins diet will be added to the ongoing anti-seizure medication regimen

Other: Modified Atkins diet

Topiramate arm

ACTIVE COMPARATOR

Topiramate will be added to the ongoing anti-seizure medication regimen

Drug: Topiramate

Interventions

Modified Atkins dietOTHER

The modified Atkins diet is a less restrictive version of the ketogenic diet

Also known as: Ketogenic diet
Modified Atkins Diet Arm
TopiramateDRUG

Topiramate is an anti-seizure medication

Topiramate arm

Eligibility Criteria

Age9 Months - 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \) 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

You may not qualify if:

  • \) 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital

New Delhi, National Capital Territory of Delhi, 110001, India

RECRUITING

Related Publications (1)

  • Meena R, Roy Chowdhury S, Elwadhi A, Jain P, Mukherjee SB, Sharma S. Modified Atkins diet versus topiramate in young children with epileptic spasms refractory to steroids and vigabatrin: a randomised open-label trial. Seizure. 2025 Sep;131:405-412. doi: 10.1016/j.seizure.2025.08.011. Epub 2025 Aug 10.

    PMID: 40840039DERIVED

MeSH Terms

Conditions

Spasms, Infantile

Interventions

Diet, KetogenicTopiramate

Condition Hierarchy (Ancestors)

Epilepsy, GeneralizedEpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEpileptic Syndromes

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-RestrictedDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaFructoseHexosesMonosaccharidesSugarsCarbohydratesKetoses

Study Officials

  • Suvasini Sharma, MD, DM

    Lady Hardinge Medical College

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Suvasini Sharma, MD, DM

CONTACT

9910234344sharma.suvasini@gmail.com

Sharmila B Mukherjee, MD

CONTACT

9818158699theshormi@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Open-label study
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 14, 2023

First Posted

July 24, 2023

Study Start

July 20, 2023

Primary Completion

September 30, 2024

Study Completion

October 31, 2024

Last Updated

July 24, 2023

Record last verified: 2023-07

Locations

IN(1)