Melatonin for the Treatment of DEE-SWAS

NCT07221968 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: IRB00478764
• Study Type: interventional
• Target: 3
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

CSWS; Developmental and/or Epileptic Encephalopathies; Electrical Status Epilepticus in Sleep

Keywords

DEE-SWAS; ESES; CSWS; epileptic encephalopathy; melatonin

Outcome Measures

Primary Outcomes (2)

• Adverse Events

  This study will evaluate for adverse events associated with single high dose melatonin administration

  Within 24 hours of dose administration

• Side effects

  This study will evaluate for multiorgan adverse effects associated with single high dose melatonin administration based on standardized questionnaire assessment. The assessment is a multiorgan adverse event questionnaire described in Jarernsiripornkul 2001, modified to reflect single dosing rather than chronic dosing. The results of this questionanaire are descriptive.

  Within 24 hours of dose administration

Secondary Outcomes (3)

• Spike wave index (SWI)

  Within 24 hours of dose administration

• Sleep spindle

  Within 24 hours of dose administration

• Salivary melatonin pharmacokinetics

  24 hours prior to intervention and 24 hours following intervention

Study Arms (1)

Melatonin

EXPERIMENTAL

Melatonin 0.3mg/kg (20mg max)

Drug: Melatonin

Interventions

Melatonin DRUG

Melatonin will be used in single fixed dose as described

Melatonin

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Post-menarchal participants. of childbearing potential with a positive urine pregnancy test

Sponsors & Collaborators

• Hugo W. Moser Research Institute at Kennedy Krieger, Inc.: lead
• Johns Hopkins University: collaborator

MeSH Terms

Interventions

Melatonin

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology

Model Details: Single dose administration

Study Record Dates

• First Submitted: October 27, 2025
• First Posted: October 29, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: October 30, 2025

Record last verified: 2025-10