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Ketogenic Diet for New-Onset Absence Epilepsy

StatusRecruiting
PhasePhase 3
Started2020-08-10
View on ClinicalTrials.gov ↗

Amendment history

2026-05-05
minor
Study Status v8
Primary completion date2026-05-01→2028-05-01
Completion date2026-05-01→2028-05-01
2025-08-07
minor
Study Status v7
Re-verified, no change to tracked fields
2024-08-05
minor
Study Status v6
Primary completion date2025-05-01→2026-05-01
Completion date2025-05-01→2026-05-01
2023-08-09
minor
Study Status, Arms and Interventions v5
Primary completion date2024-05-01→2025-05-01
Completion date2024-05-01→2025-05-01
2022-08-04
minor
Study Status v4
Primary completion date2023-05-01→2024-05-01
Completion date2023-05-01→2024-05-01
Show 3 earlier versions
2021-08-03
minor
Study Status v3
Re-verified, no change to tracked fields
2020-08-12
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2020-08-01→confirmed 2020-08-10
Study sitesdetails revised at 1 of 1 site
2020-05-15
minor
Study Status, Outcome Measures v1
Start date2020-05-01→2020-08-01
Secondary endpointsdetails revised at 1 of 5 entries
2020-02-14
minor
Original filing
The ketogenic diet is a medical therapy for epilepsy that is used nearly predominantly for refractory epilepsy (after 2-3 drugs have been tried and failed). However, there is both published evidence for first-line use (infantile spasms, Glut1 deficiency syndrome) and also anecdotal experience (families choosing to change the child's (or the family' own) diet rather than use anticonvulsant medications). Childhood absence epilepsy (refractory) has been published as being responsive to ketogenic diet therapy by the investigators' group previously. This is a small, prospective, 3 month trial to assess if using a modified Atkins diet is a feasible and effective option for new-onset childhood absence epilepsy. The investigators will compare to a group of children in which the parents have declined and chose to start anticonvulsant medications.
Trial Details
NCT Number NCT04274179
Lead Sponsor Johns Hopkins University
Conditions Absence Epilepsy, Ketogenic Dieting, Epilepsy, Absence
Enrollment 40 participants
Start Date 2020-08-10
Primary Completion 2028-05-01 (estimated)
Study Completion 2028-05-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-07