Ketogenic Diet vs.Antiepileptic Drug Treatment in Drug Resistant Epilepsy
Information source: Oslo University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Epilepsy; Mental Retardation
Intervention: Ketogenic diet (Dietary Supplement); Antiepileptic drug (AED) (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Oslo University Hospital
Official(s) and/or principal investigator(s):
Bjorn Bjurulf, MD, Principal Investigator, Affiliation: SSE, Nevrological dep., Rikshospitalet University Hospital
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.
Official title: Comparing Ketogenic Diet With the Most Appropriate Antiepileptic Drug- a Randomized Study of Children With Mental Retardation and Drug Resistant Epilepsy
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Comparing amount of patients with 100%, >90% and >50% reduction in number of seizures between the two groups of seizures
Comparing the parents´evaluation of change in quality of life and cognitive function between the two groups. The parents will answer a questionary.
Comparing side effects between the two groups
Comparing change in slow activity and epileptic activity by template matching on 24 hour EEG
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
Is the effect of the ketogenic diet as good in children with severe mental retardation as in children with less severe learning disabilities?
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
Minimum age: 2 Years.
Maximum age: 15 Years.
- 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
- 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.
- The family is expected to have compliance problems with treatment and/or seizure
- 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
- 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.
Locations and Contacts
SSE, Nevrological dep. , Rikshospitalet University hospital, Oslo, Norway
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Levy R, Cooper P. Ketogenic diet for epilepsy. Cochrane Database Syst Rev. 2003;(3):CD001903. Review. Update in: Cochrane Database Syst Rev. 2012;3:CD001903.
Kang HC, Kim YJ, Kim DW, Kim HD. Efficacy and safety of the ketogenic diet for intractable childhood epilepsy: Korean multicentric experience. Epilepsia. 2005 Feb;46(2):272-9.
Kossoff EH, Pyzik PL, McGrogan JR, Vining EP, Freeman JM. Efficacy of the ketogenic diet for infantile spasms. Pediatrics. 2002 May;109(5):780-3.
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Starting date: November 2007
Last updated: March 18, 2009