Refractory Childhood Epilepsy Clinical Trial
Official title:
Modified Atkins Diet Versus Levetiracetam for Refractory Epilepsy in Children: A Randomized Open-Label Study
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00836836 -
Modified Atkins Diet in Childhood Epilepsy
|
Phase 2/Phase 3 | |
| No longer available |
NCT02556008 -
Cannabidiol for Pediatric Epilepsy (Compassionate Use)
|
N/A |