← Back to Search

Other

Ketogenic Diet for Infantile Spasms

Phase 1

Waitlist Available

Research Sponsored by Heather Olson

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female, age 0 to less than 9 months (including neonates per investigator's judgment)

Genetic epilepsy diagnosis, pathogenic or likely pathogenic variant(s) with consistent phenotype and inheritance pattern

Must not have

Malformation of cortical development

Ongoing treatment with vigabatrin, ACTH, corticosteroids, topiramate or zonisamide

Timeline

Screening 3 weeks

Treatment Varies

Follow Up rom ketogenic diet initiation until 3 months after the diagnosis of es (if it occurs) or until 12 months of age

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to test if a high-fat, low-carbohydrate diet known as the ketogenic diet can help prevent epileptic spasms in infants with genetic seizure disorders. The study will involve 10

Who is the study for?

This trial is for infants with genetic seizure disorders, aimed at preventing epileptic spasms (ES) which can lead to developmental and cognitive issues. It's a small study of just 10 babies to see if starting them early on a ketogenic diet—a high-fat, low-carb/protein eating plan—is safe and doable.

What is being tested?

The intervention being tested is the ketogenic diet as a preventive measure against epileptic spasms in infants with genetic epilepsy. The study will assess whether this dietary approach can be safely implemented and if it has the potential to prevent ES in these high-risk patients.

What are the potential side effects?

While not explicitly stated, typical side effects of a ketogenic diet may include digestive discomfort, nutrient deficiencies over time if not carefully managed, changes in blood sugar levels, and possible impact on growth due to strict dietary restrictions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a baby less than 9 months old.

Select...

My epilepsy is caused by a specific genetic mutation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a brain development disorder.

Select...

I am currently taking medication for seizures.

Select...

I have had epileptic spasms before joining this study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ rom ketogenic diet initiation until 3 months after the diagnosis of es (if it occurs) or until 12 months of age

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~rom ketogenic diet initiation until 3 months after the diagnosis of es (if it occurs) or until 12 months of age

This trial's timeline: 3 weeks for screening, Varies for treatment, and rom ketogenic diet initiation until 3 months after the diagnosis of es (if it occurs) or until 12 months of age for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Achievement of ketosis

EEG compliance

Secondary study objectives

EEG Outcome

Epileptic Spasms Outcome

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Ketogenic dietExperimental Treatment1 Intervention

KetoVie® 4:1 Formula will be administered by oral feeding or gastrostomy tube as indicated. The duration of the diet will be from the time of enrollment up to 12 months of age or until 3 months after a diagnosis of Epileptic Spasms (range 3-15 months).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ketogenic diet

2020

Completed Early Phase 1

~720

0 / 5Eligibility criteria met