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Home > "K" Clinical Trials Conditions > Ketogenic Diet for Child Epilepsy and Seizure Control  Ketogenic Diet for Child Epilepsy and Seizure Control
Ketogenic Diet for Child Epilepsy and Seizure Control
For Condition: Epilepsy,Lennox-Gastaut Syndrome,Seizures
Status: No longer recruiting
Sponsor(s): National Institute of Neurological Disorders and Stroke (NINDS) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control
Minimum Age/Maximum Age: 1 Year/10 Years
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JohnFreeman, Principal Investigator, Johns Hopkins University
Johns Hopkins Hospital
Baltimore, Maryland, 21287
United States
Additional Information:
Study ID Numbers: R01NS35980;
Study Start Date: July 1997
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004729
Other Epilepsy Studies:
1. Search for Genes Influencing Childhood Absence Epilepsy Study
2. Monitoring Patients with Uncontrolled Epilepsy
3. Ketogenic Diet for Child Epilepsy and Seizure Control
4. Transcranial Magnetic Stimulation for the Treatment of Poorly Controlled Partial Epilepsy
5. Neuropsychological Evaluation of Psychiatric and Neurological Patients
Related Studies:
Other Epilepsy Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
Ketogenic Diet for Child Epilepsy and Seizure Control
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