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Antioxidant

Melatonin in Acute Stroke

N/A
Waitlist Available
Led By Jonathan Greco, DO
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 1
Awards & highlights
No Placebo-Only Group

Summary

This trial will test melatonin, a natural sleep aid with anti-inflammatory properties, on stroke patients. Stroke often leads to harmful inflammation and stress in the brain. Melatonin aims to reduce these issues and improve sleep, helping the brain recover better. Melatonin has been shown to have neuroprotective effects in various experimental stroke models, reducing brain tissue damage and improving recovery.

Eligible Conditions
  • Stroke

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 1 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in serum Interleukin 6 (IL 6)

Side effects data

From 2014 Phase 2 trial • 40 Patients • NCT01114373
42%
Fatigue
39%
Early Morning Wakening
36%
Daytime drowsiness
11%
Weakness
11%
Dizziness
11%
Nausea
11%
Blurred vision
100%
80%
60%
40%
20%
0%
Study treatment Arm
Melatonin
Placebo

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Melatonin GroupExperimental Treatment1 Intervention
Participants will receive 3mg of melatonin at 18:00 (+/- one hour) each evening up to seven days or for the duration of his or her hospital stay.
Group II: No Melatonin GroupActive Control1 Intervention
Participants will receive no melatonin for the length of their hospital stay.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Melatonin
2014
Completed Phase 4
~1150

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,405 Previous Clinical Trials
766,380 Total Patients Enrolled
20 Trials studying Stroke
2,358 Patients Enrolled for Stroke
Jonathan Greco, DOPrincipal InvestigatorUniversity of Florida
Andreja Packard, MD, PhDPrincipal InvestigatorUniversity of Florida
~0 spots leftby Dec 2025
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