NCT00004729

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1997

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2000

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 28, 2000

Completed
Last Updated

December 22, 2006

Status Verified

December 1, 2006

First QC Date

February 25, 2000

Last Update Submit

December 21, 2006

Conditions

EpilepsySeizuresLennox-Gastaut Syndrome

Keywords

childchildrenepilepsyseizureketogenicdietLennox-Gastaut SyndromeLGS

Interventions

Ketogenic dietBEHAVIORAL

Eligibility Criteria

Age1 Year - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

EpilepsySeizuresLennox Gastaut Syndrome

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsEpileptic SyndromesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-RestrictedDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • John M. Freeman

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

February 25, 2000

First Posted

February 28, 2000

Study Start

July 1, 1997

Last Updated

December 22, 2006

Record last verified: 2006-12

Locations

US(1)