Status:
NOT_YET_RECRUITING
Melatonin for the Treatment of DEE-SWAS
Lead Sponsor:
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborating Sponsors:
Johns Hopkins University
Conditions:
CSWS
Developmental and/or Epileptic Encephalopathies
Eligibility:
All Genders
5-17 years
Phase:
PHASE2
Brief 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 developm...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
- 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
Key Trial Info
Start Date :
July 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2028
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT07221968
Start Date
July 1 2026
End Date
December 30 2028
Last Update
October 30 2025
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