Melatonin for the Treatment of DEE-SWAS
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age5-17
SponsorHugo W. Moser Research Institute at Kennedy Krieger, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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
Abnormal baseline neuropsychiatric testing consistent with Dx Abnormal EEG
Epileptiform abnormalities (spike, polyspike, sharp) in at least 1 head region
Increase by 2-fold of epileptiform abnormalities during NREM sleep as compared to wakefulness
Disqualifiers
Allergic to ingredients in study drug Melatonin
Hypoallergenic plant fiber (cellulose)
Active use of the medication viloxazine
History of known cardiac rhythm abnormalities, heart failure or decreased EF <30%
Trial design
Treatments tested in this trial
- Melatonin
Treatment groups
3 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Lead sponsor
Johns Hopkins University
Collaborator
Source ClinicalTrials.gov