Melatonin for the Treatment of DEE-SWAS
NCT07221968 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3
Last updated 2025-10-30
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
Interventions
- DRUG
-
Melatonin
Melatonin will be used in single fixed dose as described
Sponsors & Collaborators
- collaborator OTHER
-
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 5 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-01
- Primary Completion
- 2028-07-01
- Completion
- 2028-12-30
- FDA Drug
- Yes
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