Modified Atkins Diet Versus Levetiracetam for Refractory Childhood Epilepsy

NCT ID: NCT04172311

Last Updated: 2019-11-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-14
• Study Completion Date: 2021-04-20

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.

Detailed Description

Epilepsy is a disorder of the brain characterized by an enduring predisposition to generate seizures and by the neurobiologic, cognitive, psychological and social consequences of this condition. Epilepsy is a disabling and common neurological condition which rank 4th in the world's neurological disorder burden, which can be controlled successfully in most of the patients with one or more antiepileptic drugs. But approximately 30% of patients with epilepsy have refractory epilepsy, which is, a failure to respond to adequate trials of two tolerated, appropriately chosen and used antiepileptic drug schedules to achieve sustained relief of seizures.Many severe and catastrophic epilepsies present in children such as West syndrome, Lennox Gastaut syndrome, Dravet syndrome. Uncontrolled epilepsy carries significant risks for the affected child, such as injuries, cognitive and behavioural problems. Epilepsy surgery is a good option but it is expensive and not easily available. Also, many children with refractory epilepsy are not good surgical candidates. Hence there is a need to consider alternative treatments in these children.

The ketogenic diet is an individually calculated and rigidly controlled high-fat, low carbohydrate diet used for the treatment of difficult to control seizures. The ketogenic diet is an effective treatment option for refractory childhood epilepsy however it is very restrictive and difficult to implement in low resource settings. The modified Atkins diet is a less restrictive alternative to the traditional ketogenic diet. This diet is started on an outpatient basis without a fast, and allows unlimited protein and fat. This diet has been shown to be equally effective as the ketogenic diet and a useful option in resource-constraint settings. The modified Atkins diet has been demonstrated to be effective in refractory childhood epilepsy in two randomized controlled trials from India. However, in both these trials the control groups continued their ongoing antiepileptic medication without any new treatment.

Levetiracetam is one of the newer antiepileptic drugs available for treating drug resistant epilepsy. It is a broad-spectrum antiepileptic drug effective in most seizure types. It also has an excellent pharmacokinetics and tolerability profile with no known pharmacokinetic interactions. Use of levetiracetam as an add on drug in refractory childhood epilepsy recently in some published studies has shown good efficacy.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Modified Atkins Diet

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.

Group Type: EXPERIMENTAL

Modified Atkins Diet

Intervention Type: OTHER

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

Levetiracetam

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.

Group Type: ACTIVE_COMPARATOR

Levetiracetam

Intervention Type: DRUG

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

Interventions

Modified Atkins Diet

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

Intervention Type: OTHER

Levetiracetam

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

Intervention Type: DRUG

Other Intervention Names

Ketogenic Diet subtype

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

1. Known or suspected inborn error of metabolism

2. Surgically remediable causes of epilepsy such as tumours, cortical dysplasia, mesial temporal lobe epilepsy etc with refractory focal epilepsy.

3. Prior use of the ketogenic or modified Atkins diet or levetiracetam.

4. Systemic illness- chronic hepatic, renal or pulmonary disease

5. Prior history of depression or severe behavioural problems.

-

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lady Hardinge Medical College

OTHER_GOV

Sponsor Role: lead

Responsible Party

Suvasini Sharma

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Lady Hardinge Medical College

New Delhi, National Capital Territory of Delhi, India

Site Status: RECRUITING

Countries

India

Central Contacts

Suvasini Sharma

Role: CONTACT

sharma.suvasini@gmail.com

9910234344 ext. 91

Sharmila B Mukherjee

Role: CONTACT

theshormi@gmail.com

9818159699 ext. 91

Facility Contacts

Suvasini Sharma, MD DM

Role: primary

sharma.suvasini@gmail.com

9910234344 ext. 91

Sharmila B Mukherjee, MD

Role: backup

sharma.suvasini@gmail.com

9818158699 ext. 91

Other Identifiers

LEVEMAD

Identifier Type: -

Identifier Source: org_study_id