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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05922995
The ClinicalTrials.gov registry entry for NCT05922995 describes a study currently listed as terminated, categorized as Early Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Tasimelteon is the first listed.
NCT05922995 reports 0 study locations.
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.
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