Could melatonin tame a devastating childhood epilepsy?
NCT ID NCT07221968
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether high doses of melatonin, a natural sleep hormone, can safely reduce abnormal brain activity in children with DEE-SWAS, a rare epilepsy that causes skill loss. Only 3 children will participate, and researchers will monitor side effects and changes in brain waves during sleep. It is an early step to see if this simple treatment might help.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Melatonin
- What this could lead to
- If it works, this could point toward a safe, natural treatment to reduce seizures and help children with DEE-SWAS regain lost skills.
- What could go wrong
- This is a very small, early-phase trial with only 3 participants. High doses of melatonin may cause side effects, and it is not yet known if it will improve symptoms.
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 3 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
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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5 to 17 years
- 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: Clinic Dx of DEE-SWAS 1. Dx of DEE-SWAS by a board-certified pediatric neurology/epileptologist Clinical history of delayed milestones in at least 1 category, regression of milestones in at least 1 category, and/or failure to progress in milestones in at least 1 category 2. Abnormal baseline neuropsychiatric testing consistent with Dx Abnormal EEG 3. Epileptiform abnormalities (spike, polyspike, sharp) in at least 1 head region 4. Increase by 2-fold of epileptiform abnormalities during NREM sleep as compared to wakefulness 5. SWI of ≥50% in at least one head region on overnight EEG Exclusion Criteria: 1. Allergic to ingredients in study drug Melatonin * Hypoallergenic plant fiber (cellulose) * Active use of the medication viloxazine 2. History of known cardiac rhythm abnormalities, heart failure or decreased EF \<30% 3. History of known pulm requiring oxygen or invasive positive pressure ventilation. Patients with non-invasive PPV (e.g. CPAP) due OSA w/o 02 requirement, rate, or DX of CSA, on stable pressure settings for \>3 mnths will not be excluded. 4. History of liver dysf OR AST/ALT/AlkPhos \>2.5 ULN w/i year. If lab value meeting exclusion between 3-12 months, a repeat lab value \< 2.5 ULN will be considered for inclusion 5. Post-menarchal participants. of childbearing potential with a positive urine pregnancy test
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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 official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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.
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Other studies related to the condition(s) this trial covers.