Ketogenic Diet vs.Antiepileptic Drug Treatment in Drug Resistant Epilepsy

Phase 4

• Conditions: Epilepsy; Mental Retardation
• Interventions: Dietary Supplement: Ketogenic diet; Drug: Antiepileptic drug (AED)

• Registration Number: NCT00552526
• Lead Sponsor: Oslo University Hospital

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

Study Timeline

• Study First Submitted: 2007-10-31
• Study Start: 2007-11
• Study First Submitted QC: 2007-11-01
• Study First Posted: 2007-11-02
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-18
• Last Update Posted: 2009-03-19
• Primary Completion: 2011-01
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketogenic diet	Ketogenic diet	-
AED	Antiepileptic drug (AED)	Most appropriate antiepileptic drug

Primary Outcome Measures

Name	Time	Method
Comparing amount of patients with 100%, >90% and >50% reduction in number of seizures between the two groups of seizures	4 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

SSE, Nevrological dep. , Rikshospitalet University hospital; 🇳🇴 Oslo, Norway