Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07221968

Melatonin for the Treatment of DEE-SWAS

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

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

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

  • 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

Treatment and study plan

Melatonin

Drug

Melatonin will be used in single fixed dose as described

Primary outcomes

  1. Adverse Events

    Time frame: Within 24 hours of dose administration

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

  2. Side effects

    Time frame: Within 24 hours of dose administration

    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.

Secondary outcomes

  1. Spike wave index (SWI)

    Time frame: Within 24 hours of dose administration

    This study will evaluate change in epileptiform activity during NREM sleep as defined by common clinical definition of SWI - average percentage of second bins containing an epileptiform discharge during NREM sleep

  2. Sleep spindle

    Time frame: Within 24 hours of dose administration

    This study will evaluate change in sleep spindle activity during NREM sleep using both blinded review and validated deep learning algorithmic detection.

  3. Salivary melatonin pharmacokinetics

    Time frame: 24 hours prior to intervention and 24 hours following intervention

    Baseline and post intervention salivary melatonin levels will be obtained at multiple time points

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Johns Hopkins University

Registry information

Official study title

Melatonin for the Treatment of Developmental/Epileptic Encephalopathy With Spike Wave Activation In Sleep (DEE-SWAS; Formerly ESES)

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Oct 29, 2025
Registry last updated
Oct 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.