Modified Atkins Diet Versus Levetiracetam for Refractory Childhood Epilepsy

NCT04172311 | Unknown Phase 2

• 1 other identifier: LEVEMAD
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the efficacy of add-on modified Atkins diet will be compared with add-on Levetiracetam in children with refractory epilepsy in a randomized open label trial. The results will aid clinicians in deciding the treatment options when a child has been diagnosed to have refractory epilepsy.

Conditions

Refractory Childhood Epilepsy

Outcome Measures

Primary Outcomes (1)

• Efficacy in reducing seizures measured by The proportion of responders, i.e., patients who achieve > 50% seizure reduction from the baseline in the modified Atkins diet group at 3 months in comparison to the levetiracetam group.

  The proportion of responders, i.e., patients who achieve \> 50% seizure reduction from the baseline in the modified Atkins diet group at 3 months in comparison to the levetiracetam group.

  3 months

Secondary Outcomes (1)

• Treatment emergent adverse effects in both groups

  3 months

Study Arms (2)

Modified Atkins Diet

EXPERIMENTAL

Modified Atkins Diet administration 1. Carbohydrates will be restricted to 10 grams per day. 2. Recipes will be provided to be prepared from easy home available foods, to have 2.5 gram per meal. Along with this, a list of carbohydrate free foods will be provided. 3. Fats intake will be actively encouraged. Protein intake will be unrestricted. 4. Medications will be changed to carbohydrate free preparations. 5. A multivitamin and calcium supplementation will be added.

Other: Modified Atkins Diet

Levetiracetam

ACTIVE COMPARATOR

Levetiracetam will be started at a dose of 10 mg/kg/day in two divided doses and increased to 20 mg/kg/day after 1 week. Syrups will be used in children younger than 5 years of age, and tablets will be used in children \> 5 years of age. Further dose titration will be done as per the seizure control, in 10 mg/kg/day increments in 2 weekly intervals, to a maximum of 60mg/kg/day.

Drug: Levetiracetam

Interventions

Modified Atkins Diet OTHER

Modified Atkins diet is a type of ketogenic diet which is less restrictive

Also known as: Ketogenic Diet subtype

Modified Atkins Diet

Levetiracetam DRUG

Levetiracetam is a second generation anti-epileptic drug which is broad spectrum and commonly used as add-on in refractory epilepsy

Levetiracetam

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Seizures persisting more than 3 per week despite the use of at least 2 appropriate anti-epileptic drugs in appropriate doses -

You may not qualify if:

• Known or suspected inborn error of metabolism
• Surgically remediable causes of epilepsy such as tumours, cortical dysplasia, mesial temporal lobe epilepsy etc with refractory focal epilepsy.
• Prior use of the ketogenic or modified Atkins diet or levetiracetam.
• Systemic illness- chronic hepatic, renal or pulmonary disease
• Prior history of depression or severe behavioural problems.

Sponsors & Collaborators

• Lady Hardinge Medical College: lead

Study Sites (1)

Lady Hardinge Medical College

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

RECRUITING

MeSH Terms

Interventions

Levetiracetam

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Suvasini Sharma

CONTACT

9910234344; sharma.suvasini@gmail.com

Sharmila B Mukherjee

CONTACT

9818159699; theshormi@gmail.com

Study Design

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

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: November 15, 2019
• First Posted: November 21, 2019
• Study Start: November 14, 2019
• Primary Completion: March 31, 2021
• Study Completion: April 20, 2021
• Last Updated: November 21, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)