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| Name | Class |
|---|---|
| Johns Hopkins University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melatonin | Experimental | Melatonin 0.3mg/kg (20mg max) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin | Drug | Melatonin will be used in single fixed dose as described |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | This study will evaluate for adverse events associated with single high dose melatonin administration | Within 24 hours of dose administration |
| Side effects | This study will evaluate for multiorgan adverse effects associated with single high dose melatonin administration based on standardized questionnaire assessment. The assessment is a multiorgan adverse event questionnaire described in Jarernsiripornkul 2001, modified to reflect single dosing rather than chronic dosing. The results of this questionanaire are descriptive. | Within 24 hours of dose administration |
| Measure | Description | Time Frame |
|---|---|---|
| Spike wave index (SWI) | This study will evaluate change in epileptiform activity during NREM sleep as defined by common clinical definition of SWI - average percentage of second bins containing an epileptiform discharge during NREM sleep | Within 24 hours of dose administration |
| Sleep spindle |
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Inclusion Criteria:
Clinic Dx of DEE-SWAS
Exclusion Criteria:
Allergic to ingredients in study drug Melatonin
History of known cardiac rhythm abnormalities, heart failure or decreased EF <30%
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.
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
Post-menarchal participants. of childbearing potential with a positive urine pregnancy test
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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Single dose administration
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This study will evaluate change in sleep spindle activity during NREM sleep using both blinded review and validated deep learning algorithmic detection. |
| Within 24 hours of dose administration |
| Salivary melatonin pharmacokinetics | Baseline and post intervention salivary melatonin levels will be obtained at multiple time points | 24 hours prior to intervention and 24 hours following intervention |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |