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Prevention study for Developmental and Epileptic Encephalopathies
Official title Ketogenic Diet for Prevention of Epileptic Spasms in Infantile Onset Genetic Epilepsies
ClinicalTrials.gov ID: NCT06700811
What this study is testing
What is Ketogenic diet?
Ketogenic diet is an investigational medicine, being studied as a potential treatment for developmental and epileptic encephalopathies.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 9
You may be able to join if
- 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 people need...
- Male or female, age 0 to less than 9 months (including neonates per investigator's judgment)
- Epilepsy onset at less than 6 months of age
- Abnormal development (any sub score of the Bayley-4 less than 1 standard deviation below the mean) and/or neurologic exam (microcephaly...
You likely can't join if
- Epileptic spams prior to enrollment
- Tuberous sclerosis complex, trisomy 21 (based on differential response to ES treatment)
- Metabolic diagnosis with targeted treatment (including specific indication for ketogenic diet such as glucose transporter disorder, vitamin dependent...
- Ongoing treatment with vigabatrin, ACTH, corticosteroids, topiramate or zonisamide. Other anti-seizure medications are permitted.
See the full eligibility 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 people need to receive the same formula
- Male or female, age 0 to less than 9 months (including neonates per investigator's judgment)
- Epilepsy onset at less than 6 months of age
- Abnormal development (any sub score of the Bayley-4 less than 1 standard deviation below the mean) and/or neurologic exam (microcephaly, macrocephaly, strabismus, abnormal vision/CVI, hypotonia, spasticity, dystonia...
- Suspected or confirmed genetic diagnosis as a cause for epilepsy
- Weight adequate to complete required study laboratory testing without exceeding maximum allowable blood draws per draw or in a 30 day period per BCH policy
- Epileptic spams prior to enrollment
- Tuberous sclerosis complex, trisomy 21 (based on differential response to ES treatment)
- Metabolic diagnosis with targeted treatment (including specific indication for ketogenic diet such as glucose transporter disorder, vitamin dependent epilepsies, and others) or exclusion for the ketogenic diet
- Ongoing treatment with vigabatrin, ACTH, corticosteroids, topiramate or zonisamide. Other anti-seizure medications are permitted.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0 days to 9 months. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.