Melatonin for the Treatment of DEE-SWAS

NCT ID: NCT07221968

Last Updated: 2025-10-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-07-01
• Study Completion Date: 2028-12-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Melatonin

Melatonin 0.3mg/kg (20mg max)

Group Type: EXPERIMENTAL

Melatonin

Intervention Type: DRUG

Melatonin will be used in single fixed dose as described

Interventions

Melatonin

Melatonin will be used in single fixed dose as described

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Clinic Dx of DEE-SWAS

1. 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

2. Abnormal baseline neuropsychiatric testing consistent with Dx Abnormal EEG

3. Epileptiform abnormalities (spike, polyspike, sharp) in at least 1 head region

4. Increase by 2-fold of epileptiform abnormalities during NREM sleep as compared to wakefulness

5. SWI of ≥50% in at least one head region on overnight EEG

Exclusion Criteria

1. Allergic to ingredients in study drug Melatonin

• Hypoallergenic plant fiber (cellulose)
• Active use of the medication viloxazine

2. History of known cardiac rhythm abnormalities, heart failure or decreased EF <30%

3. 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.

4. 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

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Carosella, Christopher

Assistant Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

IRB00478764

Identifier Type: -

Identifier Source: org_study_id