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Melatonin Receptor Agonist

Rozerem (Ramelteon) for Insomnia

Phase 4
Waitlist Available
Led By Anthony Lequerica, PhD
Research Sponsored by Kessler Foundation
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 after completing two weeks of treatment
Awards & highlights

Study Summary

This pilot study proposes to examine the effect of Rozerem on sleep/wake patterns among individuals with Traumatic Brain Injury (TBI) experiencing sleep disturbance, using both objective and subjective measures. It will also show that improvement in sleep/wake patterns resulting from Rozerem will impact daytime functioning using objective and subjective measures.

Eligible Conditions
  • Insomnia
  • Traumatic Brain Injury

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after completing two weeks of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and after completing two weeks of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Sleep Quality
Secondary outcome measures
Cognitive Performance
Epworth Sleepiness Scale

Side effects data

From 2008 Phase 4 trial • 50 Patients • NCT00502320
4%
Depression
4%
Nightmares
4%
Anxiety
4%
Fatigue
4%
Worsening depression leading to hospitalization
4%
Insomnia Exacerbation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ramelteon
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Rozerem (Ramelteon)Experimental Treatment1 Intervention
The primary drug of interest is a melatonin agonist for the treatment of insomnia.
Group II: Sugar pillPlacebo Group1 Intervention
Control condition.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ramelteon
FDA approved

Find a Location

Who is running the clinical trial?

Kessler FoundationLead Sponsor
174 Previous Clinical Trials
10,718 Total Patients Enrolled
Anthony Lequerica, PhDPrincipal InvestigatorKessler Foundation

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
The Journal of Rehabilitation Research and DevelopmentJournal
Awareness Problems Following Moderate to Severe Traumatic Brain Injury: Prevalence, Assessment Methods, and Injury Correlates
Vanderploeg, Rodney D.. 2007. “Awareness Problems Following Moderate to Severe Traumatic Brain Injury: Prevalence, Assessment Methods, and Injury Correlates”. The Journal of Rehabilitation Research and Development. Journal of Rehabilitation Research & Development. doi:10.1682/jrrd.2006.12.0163.
clinicaltrials.govStudy
Effect of Rozerem on Sleep Among People With Traumatic Brain Injury
Anthony Lequerica 2010. "Effect of Rozerem on Sleep Among People With Traumatic Brain Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01207050.
All > Sle > Traumatic Brain Injury
~1 spots leftby May 2025
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