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
|Condition or disease||Intervention/treatment||Phase|
|Refractory Childhood Epilepsy||Other: Modified Atkins Diet Drug: Levetiracetam||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized controlled trial|
|Masking:||None (Open Label)|
|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|
Experimental: Modified Atkins Diet
Modified Atkins Diet administration
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.
Levetiracetam is a second generation anti-epileptic drug which is broad spectrum and commonly used as add-on in refractory epilepsy
- 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.
- Treatment emergent adverse effects in both groups [ Time Frame: 3 months ]Tolerability and the adverse effects of the modified Atkins diet and levetiracetam
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
|Contact: Suvasini Sharma||9910234344 ext email@example.com|
|Contact: Sharmila B Mukherjee||9818159699 ext firstname.lastname@example.org|