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

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.

Timeline

Start

2023-09-30

Primary completion

2023-12-01

Completion

2023-12-01

Publications

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