melatonin for Semiconsciousness

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Semiconsciousness+2 More
melatonin - DietarySupplement
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Semiconsciousness
  • Consciousness Disorders

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Semiconsciousness

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: baseline, 3 months

baseline, 3 months
Medical Devices
Changes in in sleep/wake architecture following melatonin administration as assessed by time domain analysis of sleep EEG
Changes in wakeful behavior level
quantitative measures of EEG spectral content

Trial Safety

Safety Progress

1 of 3

Other trials for Semiconsciousness

Side Effects for

Melatonin
16%Fatgiue
11%Insomnia
10%Death
9%Dyspnea
9%Nausea
8%Diarrhea
5%Postoperative Pain
4%Constipation
4%Cough
3%Neutropenia
3%Headache
3%Peripheral Neuropathy
3%Vomiting
2%Appetite changes
2%Cold/Flu Symptoms
2%Dizziness
2%Air Leak
2%Chest pain
1%Subcutaneous Emphysema
1%Sinus infection
1%New Neoplasm - Lung Cancer
1%New Neoplasm
1%Flatulence
1%Pulmonary embolism
1%Prolonged Air Leak
1%Hypertension
1%Anemia
1%Pneumonia
1%Dysphagia
1%Peripheral Edema
1%Fall
1%Surgical site infection
1%Myalgia
1%Surgical Site Pain
1%Syncope
1%Hemoptysis
1%Dry Cough
1%Bonchitis
1%Pleural effusion
1%Depression
1%Pneumothorax
1%Erythema
1%Radiation pneumonitis
1%Rash
1%Hip replacement surgery
1%Acid reflux
1%Hyperglycemia
1%Anxiety
1%Vertigo
1%Gall bladder attack
1%dry mouth
1%Weight loss
1%GERD
1%Anorexia
1%Epistaxis
1%Pruritis
1%Thrush (mouth)
1%Back pain
1%C-Difficile
1%Hearing loss
1%Atrial fibrillation
1%Tinnitus
1%Indigestion
1%Tachycardia
1%Pain
This histogram enumerates side effects from a completed 2017 Phase 3 trial (NCT00668707) in the Melatonin ARM group. Side effects include: Fatgiue with 16%, Insomnia with 11%, Death with 10%, Dyspnea with 9%, Nausea with 9%.

Trial Design

2 Treatment Groups

Healthy volunteers
1 of 2
Melatonin, brain injured patients
1 of 2
Experimental Treatment

20 Total Participants · 2 Treatment Groups

Primary Treatment: melatonin · No Placebo Group · N/A

Healthy volunteers
DietarySupplement
Experimental Group · 1 Intervention: melatonin · Intervention Types: DietarySupplement
Melatonin, brain injured patients
DietarySupplement
Experimental Group · 1 Intervention: melatonin · Intervention Types: DietarySupplement
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
melatonin
2017
Completed Phase 3
~2290

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 3 months

Who is running the clinical trial?

Rockefeller UniversityLead Sponsor
150 Previous Clinical Trials
16,843 Total Patients Enrolled
Weill Medical College of Cornell UniversityOTHER
983 Previous Clinical Trials
1,338,032 Total Patients Enrolled
Nicholas Schiff, MDPrincipal InvestigatorWeill Cornell Medical College/ Rockefeller University

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 27th, 2021

Last Reviewed: October 14th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References