Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2025-12-24 @ 5:30 PM
NCT ID:
NCT07221968
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
17 Years
Study:
NCT07221968
Study Brief:
Protocol Section:
NCT07221968