- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004729
Ketogenic Diet for Child Epilepsy and Seizure Control
December 21, 2006 updated by: National Institute of Neurological Disorders and Stroke (NINDS)
Efficacy of the Ketogenic Diet -- a Blinded Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 10 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: John M. Freeman, Johns Hopkins University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 1997
Study Registration Dates
First Submitted
February 25, 2000
First Submitted That Met QC Criteria
February 25, 2000
First Posted (Estimate)
February 28, 2000
Study Record Updates
Last Update Posted (Estimate)
December 22, 2006
Last Update Submitted That Met QC Criteria
December 21, 2006
Last Verified
December 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01NS035980 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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