Your session is about to expire
← Back to Search
Melatonin Receptor Agonist
Effect of Rozerem on Sleep Among People With Traumatic Brain Injury
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
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Drug Has Already Been Approved
Pivotal Trial
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
- Traumatic Brain Injury
- Insomnia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at third week of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at third week of treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Sleep Quality
Secondary study objectives
Cognitive Performance
Epworth Sleepiness Scale
Side effects data
From 2008 Phase 4 trial • 50 Patients • NCT005023204%
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
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
183 Previous Clinical Trials
11,153 Total Patients Enrolled
Anthony Lequerica, PhDPrincipal InvestigatorKessler Foundation