Ketogenic Diet for Prevention of Epileptic Spasms in Infantile Onset Genetic Epilepsies
Recruiting
Phase 1
Interventional Study
Developmental and Epileptic Encephalopathies
Epileptic Spasms
Genetic Epilepsy
Neonatal and Infant Epilepsy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 0 Days – 9 Months
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 10 (estimated)
- Sponsor
- Heather Olson · Other
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About This Trial
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 tri…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Plan for initiation of ketogenic diet by clinical team for treatment of epilepsy
* The clinical team initiating the ketogenic diet agrees that the use of the KetoVie formula is appropriate for the subject, as all study subjects need to receive the same formula
* Male or female…
Contacts