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NCT06700811 · ClinicalTrials.gov registry record · Phase 1
Ketogenic Diet for Prevention of Epileptic Spasms in Infantile Onset Genetic Epilepsies
A Phase 1 study of Developmental and Epileptic Encephalopathies and Epileptic Spasms, sponsored by Heather Olson.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT06700811: Recruiting Phase 1 study of Developmental and Epileptic Encephalopathies and Epileptic Spasms, sponsored by Heather Olson.
NCT06700811 is a Phase 1 study of Developmental and Epileptic Encephalopathies and Epileptic Spasms that is actively recruiting participants, run by Heather Olson. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06700811, a Phase 1 study of Developmental and Epileptic Encephalopathies and Epileptic Spasms, is actively recruiting participants, sponsored by Heather Olson.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
Epileptic spasms (ES) are a predominantly infantile seizure type observed frequently in certain genetic disorders. Ketogenic diet (high ratio of fat to carbohydrate/protein) is an established non-medication treatment for difficult to control seizures, including ES. Because ES are associated with worse developmental and cognitive outcomes if not detected or treated quickly and effectively, this trial aims to test the ketogenic diet to prevent ES in this high-risk population. This trial is a single-center pilot study of 10 infants with genetic seizure disorders to establish if the protocol of early ketogenic diet administration and ES evaluation is safe and feasible.
Primary Outcome
Proportion of subjects assigned to ketogenic diet who achieve ketosis by 6 weeks and maintain a minimum ratio of 1:1 through 3 months after onset of epileptic spasms (ES) or 12 months of age
Conditions Studied
Interventions
- DRUG Ketogenic diet
Study Locations (1)
Massachusetts
- Boston Children's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2025-08-11 |
| Est. Completion | 2028-05 |
| Phase | Phase 1 |
What NCT06700811 shows while recruiting
NCT06700811 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 4 conditions, with Developmental and Epileptic Encephalopathies appearing as the primary indexed condition, and to 1 intervention - of which Ketogenic diet is the first listed.
NCT06700811 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06700811 about?
NCT06700811 is a clinical study titled "Ketogenic Diet for Prevention of Epileptic Spasms in Infantile Onset Genetic Epilepsies". Epileptic spasms (ES) are a predominantly infantile seizure type observed frequently in certain genetic disorders. Ketogenic diet (high ratio of fat to carbohydrate/protein) is an established non-medication treatment for difficult to control seizures, including ES. Because ES are associated with wor...
What is the current status of trial NCT06700811?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2025-08-11. Estimated completion is 2028-05.
What conditions does trial NCT06700811 study?
This clinical trial studies the following conditions: Developmental and Epileptic Encephalopathies, Epileptic Spasms, Genetic Epilepsy, Neonatal and Infant Epilepsy.
What interventions are being tested in trial NCT06700811?
The interventions under investigation include: Ketogenic diet (DRUG).
Who is sponsoring clinical trial NCT06700811?
This trial is sponsored by Heather Olson, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06700811 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06700811's enrollment target sits among peer trials
10 1914th of 2000 higher than 46 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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