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Hormone Therapy

Melatonin for Pediatric Traumatic Brain Injury (SMARTKids Trial)

Phase 2
Recruiting
Led By Cydni Williams, MD
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Children age ≥6 years and <19 years
Traumatic brain injury defined as disruption of the normal function of the brain resulting from blunt force injury with a severity defined as mild complicated, moderate, or severe by the Glasgow Coma Scale with the presence of intracranial injury on imaging
Must not have
Dialysis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 6-months

Summary

This trial will test if a melatonin intervention can help reduce sleep wake disturbances for pediatric TBI survivors, which will be measured by questionnaires and activity monitors.

Who is the study for?
This trial is for children aged 6 to <19 years with traumatic brain injury, who are expected to survive their hospital stay at Oregon Health & Science University Hospitals. They must be able to take medications orally within 72 hours of admission and live with a parent or guardian. Excluded are pregnant individuals, prisoners, those without stable communication means, if there's safety concerns about the intervention by the clinical team, suspected abuse cases, patients on dialysis or ECMO, or significant liver injury.
What is being tested?
The study tests whether melatonin can help kids recover better from traumatic brain injuries by improving sleep after they leave the hospital. It compares melatonin treatment started in the hospital and continued at home against a placebo (a dummy pill). The effectiveness will be measured using sleep scales and activity monitors one month post-discharge.
What are the potential side effects?
While not explicitly listed in your information provided, common side effects of melatonin may include drowsiness during daytime, headache and dizziness. As this is a controlled trial involving children recovering from TBI, close monitoring will likely identify any additional side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 6 and 18 years old.
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I have had a brain injury from a blow to the head, confirmed by brain scans.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am on dialysis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 6-months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 6-months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Recruitment
Retention
sleep disturbance
Secondary study objectives
Chronotype
Fatigue
adherence qualitative
+10 more
Other study objectives
anxiety
cognitive functioning
depression
+4 more

Side effects data

From 2017 Phase 3 trial • 709 Patients • NCT00668707
16%
Fatgiue
11%
Insomnia
10%
Death
9%
Nausea
9%
Dyspnea
8%
Diarrhea
5%
Postoperative Pain
4%
Constipation
4%
Cough
3%
Peripheral Neuropathy
3%
Vomiting
3%
Headache
3%
Neutropenia
2%
Appetite changes
2%
Air Leak
2%
Dizziness
2%
Chest pain
2%
Cold/Flu Symptoms
1%
New Neoplasm
1%
Pulmonary embolism
1%
Flatulence
1%
GERD
1%
Back pain
1%
Acid reflux
1%
Pneumothorax
1%
Weight loss
1%
Gall bladder attack
1%
Vertigo
1%
Anemia
1%
Pneumonia
1%
Bonchitis
1%
Syncope
1%
New Neoplasm - Lung Cancer
1%
Tinnitus
1%
Anorexia
1%
Anxiety
1%
Depression
1%
Subcutaneous Emphysema
1%
dry mouth
1%
Erythema
1%
Epistaxis
1%
Pruritis
1%
Rash
1%
Prolonged Air Leak
1%
Hyperglycemia
1%
Thrush (mouth)
1%
Hip replacement surgery
1%
Atrial fibrillation
1%
Indigestion
1%
Peripheral Edema
1%
C-Difficile
1%
Surgical site infection
1%
Fall
1%
Pain
1%
Radiation pneumonitis
1%
Surgical Site Pain
1%
Dry Cough
1%
Pleural effusion
1%
Hypertension
1%
Tachycardia
1%
Dysphagia
1%
Sinus infection
1%
Myalgia
1%
Hearing loss
1%
Hemoptysis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Melatonin
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MelatoninExperimental Treatment1 Intervention
(melatonin doses of 3mg or 5mg based on patient size given nightly 1 hour prior to bedtime every night for 30 days)
Group II: PlaceboPlacebo Group1 Intervention
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
melatonin
2013
Completed Phase 3
~2260

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor
1,002 Previous Clinical Trials
7,412,300 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,921 Previous Clinical Trials
47,760,592 Total Patients Enrolled
Cydni Williams, MDPrincipal InvestigatorOregon Health and Science University

Media Library

Melatonin (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04932096 — Phase 2
Traumatic Brain Injury Research Study Groups: Melatonin, Placebo
Traumatic Brain Injury Clinical Trial 2023: Melatonin Highlights & Side Effects. Trial Name: NCT04932096 — Phase 2
Melatonin (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04932096 — Phase 2
~8 spots leftby Jul 2025
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