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Sleep drug tasimelteon tested for Dream-Acting disorder

NCT ID NCT05922995

Symptom relief Sponsor: Brigham and Women's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tested whether the sleep drug tasimelteon (Hetlioz) could reduce dream-enactment events in people with REM behavior disorder. Twenty participants took a nightly 20 mg capsule and tracked their symptoms in a daily diary. The study was terminated early, so results are limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tasimelteon (Hetlioz)
What this could lead to
If it works, this could point toward a treatment to reduce dream-enactment episodes in REM behavior disorder.
What could go wrong
This was a very small, early pilot study that was terminated, so results are limited. It may not show clear benefit or be generalizable.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

20 people

The number who actually took part.

Started

Sep 2023

Finished

Dec 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: 1. Diagnosis of REM sleep behavior disorder, confirmed polysomnography 2. Ability to participate in the trial Exclusion criteria: 1. Contraindication to tasimelteon 2. medical or psychiatric conditions that limit ability to participate or increase risk to the individual

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Conditions

The condition(s) this trial relates to.

REM sleep behavior disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Rem behavior disorder

Contacts and locations

Locations

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

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