Comparing Ketogenic Diet With the Most Appropriate Antiepileptic Drug- a Randomized Study of Children With Mental Retardation and Drug Resistant Epilepsy
| Registry | NCT00552526 |
|---|---|
| Status | Unknown |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 60 (Estimated) |
| Sponsor | Oslo University Hospital (Other) |
| Conditions | Epilepsy, Mental Retardation |
| Interventions | Ketogenic diet, Antiepileptic drug (AED) (Dietary supplement, drug) |
| Dates | start 2007-11-01, primary completion 2011-01-01 (estimated), completion 2013-12-01 (estimated), first posted 2007-11-02, last updated 2009-03-19 |
| Locations | 1 site in Norway |
Related Papers Related Patents Related Grants Related Experts
All trials for Epilepsy All trials for Mental Retardation All trials of Ketogenic diet All trials of Antiepileptic drug (AED)
This is an open randomized controlled study in children with mental retardation and refractory epilepsy in which treatment with ketogenic diet (KD) is compared with treatment with the antiepileptic drug (AED), not tried by the patient before, which we consider to be the most appropriate AED for the patient.
There are two trials in the study:
* To compare the effect of the ketogenic diet with the effect of the most appropriate AED after 4 months
* To evaluate the effect of the ketogenic diet after 4 and 13 months on the children who have been randomized to this treatment, the seizure frequency is compared with the frequency before start of treatment
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Ketogenic diet | Active comparator | Dietary Supplement: Ketogenic diet | |
| AED | Active comparator | Drug: Antiepileptic drug (AED) | Most appropriate antiepileptic drug |
Sex: All, ages: 2 Years to 15 Years
Inclusion Criteria: * The patient is mentally retarded * The patient has tried at least 3 different AED:s including one combination with two or more different AED:s. * The parents are willing to include their child in the study after written and verbal information. * Patients with all types of epilepsy can be included. * The patient has at least 6 seizures/month. * The patient is submitted to our epilepsy center. * The seizures are possible to count * The patient has either generalized epilepsy, multifocal epilepsy or an epilepsy where it is undetermined whether it is localized or generalized such as Dravet syndrome classified as G40.3-G40.9 in ICD X. Exclusion Criteria: * The family is expected to have compliance problems with treatment and/or seizure registration. * The hospital which have submitted the patient is not willing to accept the inpatient stays and the procedures that are necessary for the project. * The patient's seizures are under acceptable control. * The patient has got a vagus nerve stimulator implanted within the last 18 months, has started a new antiepileptic drug within the last 2 months or has changed his antiepileptic drugs the last month. * The patient has a medical condition, for example a metabolic disease, where ketogenic diet is contraindicated. * The patient has a localized epilepsy classified as G40.0-G40.2 in ICD X. * The patient's nutritional status is not good enough or intake of fluid is to small to permit treatment with ketogenic diet. * The patient has within the last 2 months been using medications or herbal medications that has a considerable effect on glucose metabolism, such as oral glucocorticoids. * The patient has within the last 2 months been using medications or herbal medications that has a considerable effect on metabolism of AED:s. * The patient uses herbal medicine which can interact with AED or Ketogenic diet.
| Facility | City | Country | Status |
|---|---|---|---|
| SSE, Nevrological dep. , Rikshospitalet University hospital | Oslo | Norway |