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Ketogenic Diet vs.Antiepileptic Drug Treatment in Drug Resistant Epilepsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00552526
Recruitment Status : Unknown
Verified March 2009 by Oslo University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : November 2, 2007
Last Update Posted : March 19, 2009
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Epilepsy Mental Retardation Dietary Supplement: Ketogenic diet Drug: Antiepileptic drug (AED) Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparing Ketogenic Diet With the Most Appropriate Antiepileptic Drug- a Randomized Study of Children With Mental Retardation and Drug Resistant Epilepsy
Study Start Date : November 2007
Estimated Primary Completion Date : January 2011
Estimated Study Completion Date : December 2013

Arm Intervention/treatment
Active Comparator: Ketogenic diet Dietary Supplement: Ketogenic diet
Ketogenic diet is a very strict high fat diet

Active Comparator: AED
Most appropriate antiepileptic drug
Drug: Antiepileptic drug (AED)
An AED,not used by the patient before, which we consider to be the most appropriate will be given orally or by gastrostomy. Serum concentration, the body weight, side effects and effects on the epilepsy will be considered when deciding the dose of the AED. Traditions for amount of medicine/kg body weight or optimal serum concentration at our center will be followed. This tradition will be the same as in other major European epilepsy centers but might propose lower, but not higher amounts than recommended by the drug company. Drugs from ACT groups N03A, N05BA, N05CD, H02A or S01EC will be used including prednisolon,levetiracetam, valproate, carbamazepine, oxcarbazepine, topiramate, felbamate, zonisamide, vigabatrin, tiagabil, lamotrigine, pregabalin, rufinamide, clobazam, clonazepam, tiagabine, gabapentin, phenytoin, phenobarbital, ethosuximide, acetazolamide, nitrazepam and other new antiepileptic drugs that might be released during the study period.

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Comparing the parents´evaluation of change in quality of life and cognitive function between the two groups. The parents will answer a questionary. [ Time Frame: Four months ]
  2. Comparing side effects between the two groups [ Time Frame: Four months ]
  3. Comparing change in slow activity and epileptic activity by template matching on 24 hour EEG [ Time Frame: Four months ]
  4. 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 [ Time Frame: 13 months ]
  5. Is the effect of the ketogenic diet as good in children with severe mental retardation as in children with less severe learning disabilities? [ Time Frame: 4 and 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00552526

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SSE, Nevrological dep. , Rikshospitalet University hospital
Oslo, Norway
Sponsors and Collaborators
Oslo University Hospital
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Principal Investigator: Bjorn Bjurulf, MD SSE, Nevrological dep., Rikshospitalet University Hospital
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Responsible Party: Rikshospitalet-Radiumhospitalet HF (Bjorn Bjurulf), Rikshospitalet-Radiumhospitalet HF Identifier: NCT00552526    
Other Study ID Numbers: Ketogenic diet
First Posted: November 2, 2007    Key Record Dates
Last Update Posted: March 19, 2009
Last Verified: March 2009
Keywords provided by Oslo University Hospital:
Mental retardation
Ketogenic diet
Additional relevant MeSH terms:
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Drug Resistant Epilepsy
Intellectual Disability
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Neurodevelopmental Disorders
Mental Disorders