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NCT05922995 · ClinicalTrials.gov registry record · Early Phase 1
The Effects of Tasimelteon in Participants With REM Behavior Disorder (RBD)
A Early Phase 1 study, sponsored by Brigham and Women's Hospital.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 20
- Enrollment target
NCT05922995: Clinical Trial Early Phase 1 study, sponsored by Brigham and Women's Hospital.
NCT05922995 is a Early Phase 1 study that was terminated before completion, run by Brigham and Women's Hospital. The registered enrollment target is 20 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05922995, a Early Phase 1 study, was terminated before completion, sponsored by Brigham and Women's Hospital.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
To assess the effects of a daily single oral dose of 20 mg tasimelteon compared to baseline on events of dream enactment on patients with REM Behavior Disorder, as measured by a daily log. To assess the effects of 20 mg tasimelteon compared to baseline on insomnia= symptoms, as measured by validated questionnaires (Insomnia Severity Index \[ISI\], Pittsburgh Sleep Quality Inventory \[PSQI\], Epworth Sleepiness Scale \[ESS\], Clinical Global Impression of Change Scale (CGI-C), Patient Global Impression of Change Scale (PGI-C)) as well as rest/activity pattern from actigraphy. * To assess the effects of 20 mg tasimelteon on patients who have a reduced or aberrant melatonin secretion compared to normal secretion by measuring salivary DLMO at baseline and correlating with the degree of change in RBD symptoms by end of the study. * To assess for any role a patient's unique genome may play in their response to tasimelteon; obtained via whole genome sequencing. * To assess the safety and tolerability of a daily single oral dose of 20 mg tasimelteon.
Primary Outcome
The daily sleep diary contains a diagram similar to a calendar that the participant can track their intake of caffeine, medicine, and alcohol, if they exercised, when they went to bed, fell asleep, or took a nap, and when they woke up. All recordings will be measured as number of events/time of day.
Interventions
- DRUG Tasimelteon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-09-30 |
| Est. Completion | 2023-12-01 |
| Phase | Early Phase 1 |
Why NCT05922995 stopped before completion
NCT05922995 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 1 intervention - of which Tasimelteon is the first listed.
NCT05922995 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05922995 about?
NCT05922995 is a clinical study titled "The Effects of Tasimelteon in Participants With REM Behavior Disorder (RBD)". To assess the effects of a daily single oral dose of 20 mg tasimelteon compared to baseline on events of dream enactment on patients with REM Behavior Disorder, as measured by a daily log. To assess the effects of 20 mg tasimelteon compared to baseline on insomnia= symptoms, as measured by validate...
What is the current status of trial NCT05922995?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2023-09-30. Estimated completion is 2023-12-01.
What interventions are being tested in trial NCT05922995?
The interventions under investigation include: Tasimelteon (DRUG).
Who is sponsoring clinical trial NCT05922995?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05922995's enrollment target sits among peer trials
20 1157th of 2000 higher than 709 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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