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Melatonin for the Treatment of DEE-SWAS

StatusNot Yet Recruiting
PhasePhase 2
Started
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Record History

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  1. Minor Eligibility criteria revisedv2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07221968
Lead Sponsor Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborators: Johns Hopkins University
Conditions
(from sponsor)
CSWS, Developmental and/or Epileptic Encephalopathies, Electrical Status Epilepticus in Sleep
Enrollment 3 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov