Not Yet RecruitingPhase 2

Melatonin for the Treatment of DEE-SWAS

3 participantsStarted 2026-07-01

Plain-language summary

The goal of this study is to learn if melatonin, a naturally produced substance, can help to treat some of the symptoms of DEE-SWAS, a type of epilepsy that causes children to lose skills and development. It will look at doses of melatonin that are higher than most people use. The study will look at the safety of melatonin in patients with DEE-SWAS The study will look at the ways melatonin affects abnormal brain activity on a study called an EEG. The study will look at the ways melatonin affects normal brain activity that occurs in sleep.

Who can participate

Age range5 Years – 17 Years

SexALL

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Inclusion criteria

✓. 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
✓. Abnormal baseline neuropsychiatric testing consistent with Dx Abnormal EEG
✓. Epileptiform abnormalities (spike, polyspike, sharp) in at least 1 head region
✓. Increase by 2-fold of epileptiform abnormalities during NREM sleep as compared to wakefulness
✓. SWI of ≥50% in at least one head region on overnight EEG

Exclusion criteria

✕. Allergic to ingredients in study drug Melatonin
✕. History of known cardiac rhythm abnormalities, heart failure or decreased EF \<30%
✕. 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.
✕. 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
✕. Post-menarchal participants. of childbearing potential with a positive urine pregnancy test

What they're measuring

Adverse Events

Timeframe: Within 24 hours of dose administration

Side effects

Timeframe: Within 24 hours of dose administration

Trial details

NCT IDNCT07221968

SponsorHugo W. Moser Research Institute at Kennedy Krieger, Inc.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-07-01

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