Clinical Trials Directory

Trials / Not Yet Recruiting

Not Yet RecruitingNCT07221968

Melatonin for the Treatment of DEE-SWAS

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

Status
Not Yet Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
3 (estimated)
Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc. · Academic / Other
Sex
All
Age
5 Years – 17 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DRUGMelatoninMelatonin will be used in single fixed dose as described

Timeline

Start date
2026-07-01
Primary completion
2028-07-01
Completion
2028-12-30
First posted
2025-10-29
Last updated
2025-10-30

Regulatory

Source: ClinicalTrials.gov record NCT07221968. Inclusion in this directory is not an endorsement.