NCT07221968Not yet recruitingPhase 2
Melatonin for the Treatment of DEE-SWAS
Melatonin for the Treatment of Developmental/Epileptic Encephalopathy With Spike Wave Activation In Sleep (DEE-SWAS; Formerly ESES)
Source: ClinicalTrials.gov · Last updated 30 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 3 (estimated)
- First submitted
- 27 Oct 2025
- Start date
- 1 Jul 2026
- Primary completion date
- 1 Jul 2028
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Diseases
- Epilepsy
- NCT number
- NCT07221968
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 3
- From 1 Jul 2026 to the primary completion date, 1 Jul 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Allergic to ingredients in study drug Melatonin
- Hypoallergenic plant fiber (cellulose)
- Active use of the medication viloxazine
- 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.
Lab values
- 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
Other
- Post-menarchal participants. of childbearing potential with a positive urine pregnancy test
Who the study is looking for
- Clinic Dx of DEE-SWAS
- 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
Age in the registry: 5 years to 17 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.