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Melatonin for the Treatment of DEE-SWAS

ConditionsCSWSDevelopmental and/or Epileptic EncephalopathiesElectrical Status Epilepticus in Sleep
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Melatonin

    Drug

    Melatonin will be used in single fixed dose as described

Treatment groups

3 Participants
are divided into 1 treatment group
Group A: MelatoninExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adverse Events

This study will evaluate for adverse events associated with single high dose melatonin administration

Time frame
Within 24 hours of dose administration
2

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.

Time frame
Within 24 hours of dose administration

Secondary outcomes

1

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

Time frame
Within 24 hours of dose administration
2

Sleep spindle

This study will evaluate change in sleep spindle activity during NREM sleep using both blinded review and validated deep learning algorithmic detection.

Time frame
Within 24 hours of dose administration
3

Salivary melatonin pharmacokinetics

Baseline and post intervention salivary melatonin levels will be obtained at multiple time points

Time frame
24 hours prior to intervention and 24 hours following intervention

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Lead sponsor

Johns Hopkins University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: