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melatonin for Disorders of Consciousness

N/A
Waitlist Available
Led By Nicholas Schiff, MD
Research Sponsored by Rockefeller University
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, 3 months
Awards & highlights

Study Summary

This trial will study whether melatonin can help improve the sleep of patients with severe brain injuries.

Eligible Conditions
  • Disorders of Consciousness

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in in sleep/wake architecture following melatonin administration as assessed by time domain analysis of sleep EEG
Secondary outcome measures
Medical Devices
Changes in wakeful behavior level
quantitative measures of EEG spectral content

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%
Vomiting
3%
Headache
3%
Peripheral Neuropathy
3%
Neutropenia
2%
Appetite changes
2%
Air Leak
2%
Dizziness
2%
Chest pain
2%
Cold/Flu Symptoms
1%
Pneumothorax
1%
Anemia
1%
Pneumonia
1%
Erythema
1%
Back pain
1%
Bonchitis
1%
Weight loss
1%
Vertigo
1%
Anorexia
1%
Flatulence
1%
dry mouth
1%
Gall bladder attack
1%
GERD
1%
New Neoplasm - Lung Cancer
1%
Pulmonary embolism
1%
Anxiety
1%
Tinnitus
1%
Depression
1%
Syncope
1%
Acid reflux
1%
Epistaxis
1%
Pruritis
1%
Rash
1%
Prolonged Air Leak
1%
Hyperglycemia
1%
Thrush (mouth)
1%
Hip replacement surgery
1%
Subcutaneous Emphysema
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%
New Neoplasm
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
Group I: Melatonin, brain injured patientsExperimental Treatment1 Intervention
Melatonin 3mg, orally, at 8pm, daily for 3 months
Group II: Healthy volunteersExperimental Treatment1 Intervention
Melatonin 3mg, orally, at 8pm
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?

Rockefeller UniversityLead Sponsor
160 Previous Clinical Trials
16,552 Total Patients Enrolled
Weill Medical College of Cornell UniversityOTHER
1,063 Previous Clinical Trials
1,319,189 Total Patients Enrolled
1 Trials studying Disorders of Consciousness
30 Patients Enrolled for Disorders of Consciousness
Nicholas Schiff, MDPrincipal InvestigatorWeill Cornell Medical College/ Rockefeller University
~0 spots leftby Jun 2025