Status:
RECRUITING
Acute Concussion and Melatonin
Lead Sponsor:
Children's National Research Institute
Conditions:
Concussion, Mild
Concussion, Brain
Eligibility:
All Genders
12-18 years
Phase:
PHASE2
Brief 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 me...
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 ...
Eligibility Criteria
Inclusion
- Patient diagnosed with an acute concussion within 72 hours
- Patient greater than 8 and less than 19 years old
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2024
Estimated Enrollment :
254 Patients enrolled
Trial Details
Trial ID
NCT04731974
Start Date
March 1 2023
End Date
June 30 2024
Last Update
February 7 2024
Active Locations (1)
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1
Children's National Hospital
Washington D.C., District of Columbia, United States, 20010