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Ketogenic Diet for Child Epilepsy and Seizure Control

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: NCT00004729
Recruitment Status : Completed
First Posted : February 28, 2000
Last Update Posted : December 22, 2006
Information provided by:
National Institute of Neurological Disorders and Stroke (NINDS)

Brief Summary:
Twenty to thirty percent of children with epilepsy continue to suffer from seizures, even when treated with currently available anticonvulsant medications. Children with Lennox-Gastaut Syndrome (LGS) are particularly handicapped by atonic-myoclonic seizures. Preliminary data suggest that even when other medications have failed, these seizures may respond rapidly and dramatically to a high-fat-low-carbohydrate ketogenic diet. The purpose of the study is to assess if the classic ketogenic diet is efficacious in reducing seizure frequency, medication toxicity, and improves quality of life.

Condition or disease Intervention/treatment Phase
Epilepsy Seizures Lennox-Gastaut Syndrome Behavioral: Ketogenic diet Not Applicable

Detailed Description:
The ketogenic diet (KD) is a form of therapy for seizures that involves a brief period of fasting followed by a very carefully controlled high fat-low protein and carbohydrate diet. Studies suggest it is useful in children whose seizures could not be controlled by any of the medicines available. This study is designed to test, in a carefully controlled fashion, how well the diet works in children with "drop" seizures. Children who experience 15 or more drop seizures each day, despite having used at least two medications, may be eligible to participate. This study requires children to undergo periods of fasting and to maintain a carefully controlled diet. Parents of participating children monitor their children's diets and keep daily meal and seizure diaries.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Official Title: Efficacy of the Ketogenic Diet -- a Blinded Study
Study Start Date : July 1997

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • >15 myoclonic or atonic seizures a day
  • EEG with Lennox-Gastaut pattern

Exclusion Criteria:

  • <15 atonic or myoclonic seizures a day
  • on >3 medications
  • previously on diet and/or evidence of metabolic disorder

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): NCT00004729

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United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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Principal Investigator: John M. Freeman Johns Hopkins University
Layout table for additonal information Identifier: NCT00004729    
Other Study ID Numbers: R01NS035980 ( U.S. NIH Grant/Contract )
First Posted: February 28, 2000    Key Record Dates
Last Update Posted: December 22, 2006
Last Verified: December 2006
Keywords provided by National Institute of Neurological Disorders and Stroke (NINDS):
Lennox-Gastaut Syndrome
Additional relevant MeSH terms:
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Lennox Gastaut Syndrome
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Epileptic Syndromes
Genetic Diseases, Inborn