The Effects of Tasimelteon in Participants With REM Behavior Disorder (RBD)
Status:
TERMINATED
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
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.