Comparing Ketogenic Diet With the Most Appropriate Antiepileptic Drug- a Randomized Study of Children With Mental Retardation and Drug Resistant Epilepsy

Oslo University Hospital1 site in 1 country60 target enrollmentNovember 2007

ConditionsEpilepsy Mental Retardation

InterventionsKetogenic diet Antiepileptic drug (AED)

DrugsAntiepileptic drug (AED)

Overview

Phase: Phase 4
Intervention: Ketogenic diet
Conditions: Epilepsy
Sponsor: Oslo University Hospital
Enrollment: 60
Locations: 1
Primary Endpoint: Comparing amount of patients with 100%, >90% and >50% reduction in number of seizures between the two groups of seizures
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed 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

Registry

clinicaltrials.gov

Start Date

November 2007

End Date

December 2013

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Oslo University Hospital

Eligibility Criteria

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.

Arms & Interventions

Ketogenic diet

Intervention: Ketogenic diet

AED

Most appropriate antiepileptic drug

Intervention: Antiepileptic drug (AED)

Outcomes

Primary Outcomes

Comparing amount of patients with 100%, >90% and >50% reduction in number of seizures between the two groups of seizures

Time Frame: 4 months

Secondary Outcomes

Comparing the parents´evaluation of change in quality of life and cognitive function between the two groups. The parents will answer a questionary.(Four months)
Comparing side effects between the two groups(Four months)
Comparing change in slow activity and epileptic activity by template matching on 24 hour EEG(Four months)
Investigating side effects and change in number of seizures, change in EEG, quality of life and cognitive function after 13 months of treatment with the ketogenic diet(13 months)
Is the effect of the ketogenic diet as good in children with severe mental retardation as in children with less severe learning disabilities?(4 and 12 months)