Melatonin for the Treatment of DEE-SWAS

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

Status and phase: Begins enrollment in 4 months; Phase 2

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

Treatments: Drug: Melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT07221968

IRB00478764

Details and patient eligibility

About

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.

Enrollment: 3 estimated patients

Sex: All

Ages: 5 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Melatonin

Experimental group

Description:

Melatonin 0.3mg/kg (20mg max)

Treatment:

Drug: Melatonin