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Efficacy of Ramelteon in Adults With Chronic Insomnia
Phase 3
Waitlist Available
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial
Approved for 5 Other Conditions
All Individual Drugs Already Approved
Summary
The purpose of this study is to evaluate subjectively reported treatment effects of ramelteon, once daily (QD), in adults with chronic insomnia.
Eligible Conditions
- Chronic Insomnia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Ramelteon 8 mg QDExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
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?
TakedaLead Sponsor
1,240 Previous Clinical Trials
4,146,596 Total Patients Enrolled
VP Clinical ScienceStudy DirectorTakeda
16 Previous Clinical Trials
4,724 Total Patients Enrolled