Could a Weight-Loss drug stop seizures in babies?
NCT ID NCT04289467
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests the drug fenfluramine in 10 children aged 12 to 36 months whose infantile spasms did not get better with standard treatments. The children take fenfluramine for 21 days, and doctors check brain waves and seizure diaries to see if the spasms stop. If it helps, they can continue treatment for up to 6 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- fenfluramine
- What this could lead to
- If it works, this could offer a new treatment option for children with hard-to-control infantile spasms.
- What could go wrong
- This is a very small, early-phase trial with only 10 children. It may not show clear benefit, and fenfluramine can have side effects like heart valve problems.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2023
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 to 36 months
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Children ages 12 to 36 months, inclusive * Clinical diagnosis of infantile spasms * Continued epileptic spasms despite adequate treatment with ACTH and vigabatrin. Exclusion Criteria: * Significant preexisting cardiovascular disease * Exposure to any cannabinoid product within 14 days of screening * Initiation or dose-titration of any second-line treatment for infantile spasms in the 14 days prior to screening. * Implantation of a vagal nerve simulator within 14 days of screening * Initiation and maintenance of the ketogenic diet within 3 months of screening
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Children's Hospital of Orange County
RECRUITINGOrange, California, 92868, United States
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UCLA Health
NOT_YET_RECRUITINGLos Angeles, California, 90095, United States
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