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Modified Atkins Diet Versus Levetiracetam for Refractory Childhood Epilepsy (LEVEMAD)

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ClinicalTrials.gov Identifier: NCT04172311
Recruitment Status : Recruiting
First Posted : November 21, 2019
Last Update Posted : November 21, 2019
Sponsor:
Information provided by (Responsible Party):
Suvasini Sharma, Lady Hardinge Medical College

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.

Condition or disease Intervention/treatment Phase
Refractory Childhood Epilepsy Other: Modified Atkins Diet Drug: Levetiracetam Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Modified Atkins Diet Versus Levetiracetam for Refractory Epilepsy in Children: A Randomized Open-Label Study
Actual Study Start Date : November 14, 2019
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : April 20, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arm Intervention/treatment
Experimental: 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.
Other: Modified Atkins Diet
Modified Atkins diet is a type of ketogenic diet which is less restrictive
Other Name: Ketogenic Diet subtype

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




Primary Outcome Measures :
  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. [ Time Frame: 3 months ]
    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.


Secondary Outcome Measures :
  1. Treatment emergent adverse effects in both groups [ Time Frame: 3 months ]
    Tolerability and the adverse effects of the modified Atkins diet and levetiracetam



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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

    -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04172311


Contacts
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Contact: Suvasini Sharma 9910234344 ext 91 sharma.suvasini@gmail.com
Contact: Sharmila B Mukherjee 9818159699 ext 91 theshormi@gmail.com

Locations
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India
Lady Hardinge Medical College Recruiting
New Delhi, Delhi, India, 110018
Contact: Suvasini Sharma, MD DM    9910234344 ext 91    sharma.suvasini@gmail.com   
Contact: Sharmila B Mukherjee, MD    9818158699 ext 91    sharma.suvasini@gmail.com   
Sponsors and Collaborators
Lady Hardinge Medical College

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Responsible Party: Suvasini Sharma, Associate Professor, Lady Hardinge Medical College
ClinicalTrials.gov Identifier: NCT04172311     History of Changes
Other Study ID Numbers: LEVEMAD
First Posted: November 21, 2019    Key Record Dates
Last Update Posted: November 21, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Levetiracetam
Anticonvulsants
Nootropic Agents