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Melatonin Receptor Agonist

Tasimelteon for REM Sleep Behavior Disorder (RBD Trial)

Q: Are there any opportunities for recruitment in this clinical trial at present?

Based on the information provided by clinicaltrials.gov, this study is not presently recruiting patients. The trial was first posted in September 30th 2023 and has since been revised as of June 27th 2023. Although it isn't accepting applications at present, there are 382 other trials actively seeking participants right now.

Q: How can I become a participant in this research endeavor?

This clinical trial is in search of 20 individuals between the ages 18 and 85 who have been diagnosed with rem behavior disorder.

Q: Is the eligibility criteria for this trial inclusive of individuals above 30 years old?

To be accepted into this medical experiment, participants must have an age that falls between 18 and 85. Separately, there are 112 studies for individuals who are younger than 18 and 244 for those aged 65 or above.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month after study for reporting.

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 more

Secondary outcome measures

Clinical Global Impression of Change

Side effects data

From 2018 Phase 3 trial • 320 Patients • NCT03373201

Headache

Atrial Fibrillation

100%

80%

60%

40%

20%

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor

1,608 Previous Clinical Trials

11,469,857 Total Patients Enrolled

Vanda PharmaceuticalsIndustry Sponsor

61 Previous Clinical Trials

19,381 Total Patients Enrolled

Milena Pavlova, M.D.Principal InvestigatorBrigham and Women's Hospital

Media Library

Tasimelteon (Melatonin Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05922995 — Phase < 1

REM Behavior Disorder Research Study Groups: Treatment Phase

REM Behavior Disorder Clinical Trial 2023: Tasimelteon Highlights & Side Effects. Trial Name: NCT05922995 — Phase < 1

Tasimelteon (Melatonin Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05922995 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities for recruitment in this clinical trial at present?

"Based on the information provided by clinicaltrials.gov, this study is not presently recruiting patients. The trial was first posted in September 30th 2023 and has since been revised as of June 27th 2023. Although it isn't accepting applications at present, there are 382 other trials actively seeking participants right now."

Answered by AI

How can I become a participant in this research endeavor?

"This clinical trial is in search of 20 individuals between the ages 18 and 85 who have been diagnosed with rem behavior disorder."

Answered by AI

Is the eligibility criteria for this trial inclusive of individuals above 30 years old?

"To be accepted into this medical experiment, participants must have an age that falls between 18 and 85. Separately, there are 112 studies for individuals who are younger than 18 and 244 for those aged 65 or above."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Effects of Tasimelteon in Participants With REM Behavior Disorder (RBD)

Pavlova, Milena,M.D. 2023. "The Effects of Tasimelteon in Participants With REM Behavior Disorder (RBD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05922995.