Ketogenic Diet vs.Antiepileptic Drug Treatment in Drug Resistant Epilepsy

University of Oslo (UIO)

Status and phase

Unknown

Phase 4

Conditions

Epilepsy

Mental Retardation

Treatments

Dietary Supplement: Ketogenic diet

Drug: Antiepileptic drug (AED)

Study type

Interventional

Funder types

Other

Identifiers

NCT00552526

Ketogenic diet

EudraCT:2006-001776-20

Details and patient eligibility

About

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.

Full description

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

Enrollment

60 estimated patients

Sex

All

Ages

2 to 15 years old

Volunteers

No Healthy Volunteers

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.