Concussion, MildPhase 2NCT04731974
Acute Concussion and Melatonin
A Phase 2 study testing Melatonin 3 MG in people with Concussion, Mild and Concussion, Brain, run by Children's National Research Institute at 1 site in United States.
Trial summary
In this study, the investigator plans a randomized trial of melatonin versus placebo post acute pediatric concussion. The investigator hypothesizes that patients with acute concussions managed with melatonin will have improved sleep, decreased depressive symptoms, decreased risk of prolonged concussion symptoms and… Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Concussion, Mild, Concussion, Brain, Pediatric ALL
- What is being tested?
- Melatonin 3 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 254 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 30 Jun 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patient diagnosed with an acute concussion within 72 hours
- Patient greater than 8 and less than 19 years old
Who cannot join
- Currently taking psychiatric medication
- Cognitive delay
- Glasgow Coma Score < 14
- positive findings on head computed tomography
- Any patient with intracranial surgery, pathology or instrumentation (e.g. ventriculoperitoneal shunt, brain tumor etc)
- Use of melatonin within the last week
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Children's National Hospital
Washington D.C., District of Columbia, 20010
Jeremy M Root, MD, jroot@cnmc.org
About this study
Official title: The Effectiveness of Melatonin for the Treatment of Acute Pediatric Concussion
In this study, the investigator plans a randomized trial of melatonin versus placebo post acute pediatric concussion. The investigator hypothesizes that patients with acute concussions managed with melatonin will have improved sleep, decreased depressive symptoms, decreased risk of prolonged concussion symptoms and faster resolution of concussion symptoms.
Read the detailed description
To compare the risk of persistent post-concussive symptoms (PPCS) between melatonin and placebo after an acute pediatric concussion.
To determine if melatonin compared to placebo reduces the risk of PPCS for pediatric patients.
This is a prospective single-blinded randomized control trial of pediatric patients in the emergency department (ED) diagnosed with an acute concussion. Patients 12-18 years old with an acute concussion diagnosis will be eligible. All participants will receive actigraphy watches to wear on their wrists and measure sleep and activity patterns. Participants in the melatonin group will be instructed to take 3 mg of liquid melatonin 1 hour prior to their habitual fall asleep time daily for 30 days. Participants in the placebo group will be instructed to take their placebo liquid 1/2 hour prior to their habitual fall asleep time daily for 30 days.
All participants will be given standardized weekly assessments to track their concussion, sleep and depressive symptoms for one month. Research assistants will also arrange follow up in the telemedicine neurology headache clinic within 4 weeks post injury. At the follow-up visit, subjects will complete the Post Concussion Symptom Inventory (PCSI), Pediatric Sleep Disturbance (PSD), and Revised Childhood Anxiety and Depression Scales (RCADS).
- Conditions
- Concussion, Mild, Concussion, Brain, Pediatric ALL
- Being tested
- Melatonin 3 MG, Placebo
- Medical subject headings
- Brain Concussion, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin 3 MGDrug
Participants in the melatonin group will be instructed to take 3-mg liquid melatonin pill 1 hour prior to their habitual fall asleep time daily for 30 days.
PlaceboOther
Participants in the placebo group will be instructed to take liquid placebo pill 1 hour prior to their habitual fall asleep time daily for 30 days.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Liquid Placebo Receives: Other: Placebo |
| Melatonin | Active comparator | Liquid Melatonin Receives: Drug: Melatonin 3 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of average daily sleep duration between melatonin and placebo post acute pediatric concussion
It is hypothesized that subjects managed with melatonin post an acute concussion will have increased sleep duration compared to placebo
Measured: 28 days post Emergency Department visit
Change in sleep quality between melatonin and placebo post acute pediatric concussion
It is hypothesized that subjects managed with melatonin post an acute concussion will have increased sleep quality compared to placebo
Measured: 28 days post Emergency Department visit
Change in depressive symptoms between melatonin and placebo post acute pediatric concussion
It is hypothesized that subjects managed with melatonin post an acute concussion will have decreased depressive symptoms compared to placebo
Measured: 28 days post Emergency Department visit
Secondary outcomes (2)
Risk of persistent post-concussive symptoms between melatonin and placebo post acute pediatric concussion
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
Measured: 28 days post Emergency Department visit
Time to resolution of concussion symptoms between melatonin and placebo post acute pediatric concussion
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
Measured: 28 days post Emergency Department visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start1 Mar 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Concussion, MildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective single blinded randomized control trial of pediatric patients in the emergency department (ED) diagnosed with an acute concussion. Group A: melatonin Group B: routine/standard care
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 254 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeremy Root, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04731974
- Sponsor's protocol ID
- Pro00015567
- Status last verified
- Feb 2024
- First submitted
- 20 Jan 2021
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: For the study, researchers will collect the age, sex, past medical history and through surveys, past, present and future symptoms after a head injury. This information will be used to determine which age groups are at risk and which constellation of symptoms persist following an acute head injury. All research documents and protected health information will be kept in a locked cabinet and a password protected RedCap database that only study staff personnel have access to. No data will be shared until manuscript is written, but will only be shared in manuscript and not in individual data. If significant adverse data is found for a patient, the Lead principal investigator will discuss with the subject and primary care physician.
Publications
Barlow KM, Brooks BL, Esser MJ, Kirton A, Mikrogianakis A, Zemek RL, MacMaster FP, Nettel-Aguirre A, Yeates KO, Kirk V, Hutchison JS, Crawford S, Turley B, Cameron C, Hill MD, Samuel T, Buchhalter J, Richer L, Platt R, Boyd R, Dewey D. Efficacy of Melatonin in Children With Postconcussive Symptoms: A Randomized Clinical Trial. Pediatrics. 2020 Apr;145(4):e20192812. doi: 10.1542/peds.2019-2812. Epub 2020 Mar 26.
PubMed 32217739
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Melatonin for the Treatment of Acute Pediatric Concussion
- ClinicalTrials.gov ID
- NCT04731974
- Acronym / sponsor ID
- Pro00015567
- Conditions
- Concussion, Mild, Concussion, Brain, Pediatric ALL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 254 participants (estimated)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 1 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, the investigator plans a randomized trial of melatonin versus placebo post acute pediatric concussion. The investigator hypothesizes that patients with acute concussions managed with melatonin will have improved sleep, decreased depressive symptoms, decreased risk of prolonged concussion symptoms and faster resolution of concussion symptoms.
Detailed description
To compare the risk of persistent post-concussive symptoms (PPCS) between melatonin and placebo after an acute pediatric concussion.
To determine if melatonin compared to placebo reduces the risk of PPCS for pediatric patients.
This is a prospective single-blinded randomized control trial of pediatric patients in the emergency department (ED) diagnosed with an acute concussion. Patients 12-18 years old with an acute concussion diagnosis will be eligible. All participants will receive actigraphy watches to wear on their wrists and measure sleep and activity patterns. Participants in the melatonin group will be instructed to take 3 mg of liquid melatonin 1 hour prior to their habitual fall asleep time daily for 30 days. Participants in the placebo group will be instructed to take their placebo liquid 1/2 hour prior to their habitual fall asleep time daily for 30 days.
All participants will be given standardized weekly assessments to track their concussion, sleep and depressive symptoms for one month. Research assistants will also arrange follow up in the telemedicine neurology headache clinic within 4 weeks post injury. At the follow-up visit, subjects will complete the Post Concussion Symptom Inventory (PCSI), Pediatric Sleep Disturbance (PSD), and Revised Childhood Anxiety and Depression Scales (RCADS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a prospective single blinded randomized control trial of pediatric patients in the emergency department (ED) diagnosed with an acute concussion. Group A: melatonin Group B: routine/standard care
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboLiquid Placebo |
| Melatonin | Active comparator | Drug: Melatonin 3 MGLiquid Melatonin |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patient diagnosed with an acute concussion within 72 hours
- Patient greater than 8 and less than 19 years old
Key exclusion criteria (6 listed)
- Currently taking psychiatric medication
- Cognitive delay
- Glasgow Coma Score < 14
- positive findings on head computed tomography
- Any patient with intracranial surgery, pathology or instrumentation (e.g. ventriculoperitoneal shunt, brain tumor etc)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melatonin 3 MGParticipants in the melatonin group will be instructed to take 3-mg liquid melatonin pill 1 hour prior to their habitual fall asleep time daily for 30 days. | Drug | Melatonin |
| PlaceboParticipants in the placebo group will be instructed to take liquid placebo pill 1 hour prior to their habitual fall asleep time daily for 30 days. | Other | Placebo |
Primary outcome
Comparison of average daily sleep duration between melatonin and placebo post acute pediatric concussion
Time frame: 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
Change in sleep quality between melatonin and placebo post acute pediatric concussion
Time frame: 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
Change in depressive symptoms between melatonin and placebo post acute pediatric concussion
Time frame: 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
2 secondary outcomes
Risk of persistent post-concussive symptoms between melatonin and placebo post acute pediatric concussion
Time frame: 28 days post Emergency Department visit
Time to resolution of concussion symptoms between melatonin and placebo post acute pediatric concussion
Time frame: 28 days post Emergency Department visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Background: PubMed 32217739Barlow KM, Brooks BL, Esser MJ, Kirton A, Mikrogianakis A, Zemek RL, MacMaster FP, Nettel-Aguirre A, Yeates KO, Kirk V, Hutchison JS, Crawford S, Turley B, Cameron C, Hill MD, Samuel T, Buchhalter J, Richer L, Platt R, Boyd R, Dewey D. Efficacy of Melatonin in Children With Postconcussive Symptoms: A Randomized Clinical Trial. Pediatrics. 2020 Apr;145(4):e20192812. doi: 10.1542/peds.2019-2812. Epub 2020 Mar 26.
- Individual participant dataSharing planned: No. For the study, researchers will collect the age, sex, past medical history and through surveys, past, present and future symptoms after a head injury. This information will be used to determine which age groups are at risk and which constellation of symptoms persist following an acute head injury. All research documents and protected health information will be kept in a locked cabinet and a password protected RedCap database that only study staff personnel have access to. No data will be shared until manuscript is written, but will only be shared in manuscript and not in individual data. If significant adverse data is found for a patient, the Lead principal investigator will discuss with the subject and primary care physician.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Melatonin 3 MG in people with Concussion, Mild and Concussion, Brain, run by Children's National Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeremy M Root, MD (703-407-6738, jroot@childrensnational.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of average daily sleep duration between melatonin and placebo post acute pediatric concussion (time frame: 28 days post Emergency Department visit). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04731974, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.