Trial · NCT07221968
Melatonin for the Treatment of DEE-SWAS
NCT07221968, Phase 2, Not yet recruiting, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Melatonin for the Treatment of DEE-SWAS. Trials, record NCT07221968. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07221968
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Melatonin for the Treatment of DEE-SWAS
- NCT number
- NCT07221968
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 3 participants, estimated
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Conditions
- CSWS, Developmental and/or Epileptic Encephalopathies, Electrical Status Epilepticus in Sleep
- Interventions
- Melatonin
- First posted
- 2025-10-29
- Last updated
- 2025-10-30
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Adverse Events | Within 24 hours of dose administration | This study will evaluate for adverse events associated with single high dose melatonin administration |
| Primary | Side effects | Within 24 hours of dose administration | 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. |
| Secondary | Spike wave index (SWI) | Within 24 hours of dose administration | 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 |
| Secondary | Sleep spindle | Within 24 hours of dose administration | This study will evaluate change in sleep spindle activity during NREM sleep using both blinded review and validated deep learning algorithmic detection. |
| Secondary | Salivary melatonin pharmacokinetics | 24 hours prior to intervention and 24 hours following intervention | Baseline and post intervention salivary melatonin levels will be obtained at multiple time points |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07221968
GET https://conductscience.org/api/trials/v1/NCT07221968/registered