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Melatonin Receptor Agonist
Tasimelteon for REM Sleep Behavior Disorder (RBD Trial)
Phase < 1
Waitlist Available
Led By Milena Pavlova, M.D.
Research Sponsored by Brigham and Women's Hospital
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 1 month after study
Awards & highlights
RBD Trial Summary
This trial assesses the effects of 20 mg tasimelteon on REM Behavior Disorder, insomnia symptoms, melatonin secretion, and safety/tolerability.
Who is the study for?
This trial is for individuals who have been diagnosed with REM Sleep Behavior Disorder, confirmed by a sleep study. Participants must be able to engage in the trial activities and not have any medical or psychiatric conditions that could limit their participation or increase their risk.Check my eligibility
What is being tested?
The trial is testing the effects of a daily dose of tasimelteon (20 mg) on dream enactment behaviors in RBD patients. It also examines its impact on insomnia symptoms using questionnaires and activity patterns via actigraphy, as well as how melatonin secretion levels and genetics might influence treatment response.See study design
What are the potential side effects?
While specific side effects are not listed here, the safety and tolerability of taking a daily single oral dose of 20 mg tasimelteon will be assessed throughout the study.
RBD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month after study
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month after study
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Daily Sleep Diary - Dream Enactment
Daily Sleep Diary - Sleep Questions
Daily Sleep Diary - Time Keeping
+1 moreSecondary outcome measures
Clinical Global Impression of Change
Side effects data
From 2018 Phase 3 trial • 320 Patients • NCT033732015%
Headache
1%
Atrial Fibrillation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Tasimelteon
RBD Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment PhaseExperimental Treatment1 Intervention
Tasimelteon will be administered in 20 mg capsules on a nightly basis for 4 weeks during the treatment phase.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tasimelteon
2016
Completed Phase 3
~540
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Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,622 Previous Clinical Trials
11,468,724 Total Patients Enrolled
Vanda PharmaceuticalsIndustry Sponsor
61 Previous Clinical Trials
19,384 Total Patients Enrolled
Milena Pavlova, M.D.Principal InvestigatorBrigham and Women's Hospital
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with REM sleep behavior disorder through a sleep study.I am able to take part in the clinical trial.I cannot take tasimelteon due to health reasons.I do not have any health or mental conditions that would make it unsafe for me to join.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Phase
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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