NCT03807141

Brief Summary

Epileptic spasms are a difficult to treat epileptic condition in young children. The first line treatment is hormonal treatment, in the form of ACTH or oral steroids, which are effective in 60-70% of children. The condition does not respond well to other anti-epileptic drugs except vigabatrin which is not approved and hence has limited availability and high cost in India. The ketogenic diet, a high fat low carbohydrate diet has been found to be effective in refractory childhood epilepsy especially epileptic spasms. However, the ketogenic diet restricts calories and proteins and required strict weighing of foods. The modified Atkins diet (MAD) is a less restrictive diet which is easier for the parents to prepare and for the children to consume. In this study, it is planned to evaluate the efficacy of the MAD in children with epileptic spasms refractory to hormonal treatment in a randomized controlled trial.

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
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2019

Typical duration 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

January 4, 2019

Completed
11 days until next milestone

Study Start

First participant enrolled

January 15, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 16, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

February 5, 2019

Status Verified

February 1, 2019

Enrollment Period

3 years

First QC Date

January 4, 2019

Last Update Submit

February 1, 2019

Conditions

Epileptic Spasms

Outcome Measures

Primary Outcomes (1)

  • Proportion of children who achieved spasm freedom as per parental reports at 4 weeks, in both the groups

    The proportion of children who achieve spasm freedom for at least 48 hours as per parental reports at the end of 4 weeks will be evaluated in the both the groups

    4 weeks

Secondary Outcomes (3)

  • Proportion of children who achieved >50% reduction of clinical spasm, as per parental reports at 4 weeks, in both the groups.

    4 weeks

  • Proportion of children who achieve resolution of hypsarrhythmia on electro encephalogram at 4 weeks in both the groups.

    4 weeks

  • Description and proportion of the adverse effects of the diet as per parental reports in the diet group

    4 weeks

Study Arms (2)

Diet arm

EXPERIMENTAL

Modified Atkins diet will be administered with carbohydrate restriction to 10 grams per day. Proteins will be allowed unrestricted and fats will be actively encouraged. The ongoing antiepileptic medication will be continued unchanged

Other: Modified Atkins diet

Control

NO INTERVENTION

The control group will continue their anti-epileptic medication unchanged with no additional dietary input

Interventions

Modified Atkins dietOTHER

This is a modified version of the ketogenic diet where-in carbohydrates are restricted without any protein or calorie restriction.

Diet arm

Eligibility Criteria

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

You may qualify if:

  • Age 9 months to 3 years
  • Presence of epileptic spasms in clusters in child 9 months to \<3years of age, with electroencephalographic evidence of hypsarrhythmia or its variants, persisting, at least one cluster per day, despite treatment with either oral corticosteroids or adrenocorticotrophic hormone (ACTH) and one additional anticonvulsant (valproate/ benzodiazepine/ vigabatrin/ topiramate/ zonisamide/ levetiracetam) for at least 4 weeks.

You may not qualify if:

  • Children with known or suspected inborn error of metabolism
  • Children with renal, pulmonary, cardiac or hepatic dysfunction
  • Severe malnutrition (weight for length or weight for height less than -3 Z score as per WHO growth charts)
  • Motivational or psychosocial issues in the family which might affect the compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lady Hardinge Medical College

New Delhi, National Capital Territory of Delhi, 110018, India

RECRUITING

Related Publications (1)

  • Sharma S, Goel S, Kapoor D, Garg D, Panda I, Elwadhi A, Patra B, Mukherjee SB, Pemde H. Evaluation of the Modified Atkins Diet for the Treatment of Epileptic Spasms Refractory to Hormonal Therapy: A Randomized Controlled Trial. J Child Neurol. 2021 Jul;36(8):686-691. doi: 10.1177/08830738211004747. Epub 2021 Apr 9.

    PMID: 33834913DERIVED

MeSH Terms

Conditions

Spasms, Infantile

Condition Hierarchy (Ancestors)

Epilepsy, GeneralizedEpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEpileptic Syndromes

Central Study Contacts

Suvasini Sharma

CONTACT

09910234344sharma.suvasini@gmail.com

Study Design

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

Study Record Dates

First Submitted

January 4, 2019

First Posted

January 16, 2019

Study Start

January 15, 2019

Primary Completion

January 14, 2022

Study Completion

March 31, 2022

Last Updated

February 5, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)