Trial · NCT04731974
Acute Concussion and Melatonin
NCT04731974, Phase 2, Unknown, Children's National Research Institute
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Acute Concussion and Melatonin. Trials, record NCT04731974. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04731974
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Acute Concussion and Melatonin
- NCT number
- NCT04731974
- Status
- Unknown
- Phases
- Phase 2
- Enrollment
- 254 participants, estimated
- Lead sponsor
- Children's National Research Institute
- Conditions
- Concussion, Mild, Concussion, Brain, Pediatric ALL
- Interventions
- Melatonin 3 MG, Placebo
- First posted
- 2021-02-01
- Last updated
- 2024-02-07
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Comparison of average daily sleep duration between melatonin and placebo post acute pediatric concussion | 28 days post Emergency Department visit | It is hypothesized that subjects managed with melatonin post an acute concussion will have increased sleep duration compared to placebo |
| Primary | Change in sleep quality between melatonin and placebo post acute pediatric concussion | 28 days post Emergency Department visit | It is hypothesized that subjects managed with melatonin post an acute concussion will have increased sleep quality compared to placebo |
| Primary | Change in depressive symptoms between melatonin and placebo post acute pediatric concussion | 28 days post Emergency Department visit | It is hypothesized that subjects managed with melatonin post an acute concussion will have decreased depressive symptoms compared to placebo |
| Secondary | Risk of persistent post-concussive symptoms between melatonin and placebo post acute pediatric concussion | 28 days post Emergency Department visit | It is hypothesized that subjects managed with melatonin post an acute concussion will have a decreased relative risk of PPCS compared to those managed with placebo |
| Secondary | Time to resolution of concussion symptoms between melatonin and placebo post acute pediatric concussion | 28 days post Emergency Department visit | It is hypothesized that subjects managed with melatonin post an acute concussion will have a decreased time to resolution of concussion symptoms compared to those managed with placebo |
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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32217739 | BACKGROUND |
Source PubMed
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/NCT04731974
GET https://conductscience.org/api/trials/v1/NCT04731974/registered