A multicenter, double-blind, randomized study to evaluate the effects of tasimelteon vs. placebo in participants with Delayed Sleep-Wake Phase Disorder (DSWPD)

Conditions

Delayed Sleep-Wake Phase Disorder (DSWPD)

Brief summary

To assess the effects of a daily single oral dose of 20 mg tasimelteon compared to placebo on Sleep Onset (change from baseline) in participants over a 28-day period, as measured by sleep diary.

Detailed description

To assess the effects of 20 mg tasimelteon compared to placebo on Sleep Onset (change from baseline) during the treatment phase, as measured by actigraphy., To assess the effects of 20 mg tasimelteon compared to placebo on nighttime subjective sleep parameters such as SOL, wake time, midpoint of sleep, and total sleep time (change from baseline), as measured by sleep diary., To assess the effects of 20 mg tasimelteon compared to placebo on nighttime objective sleep parameters such as SOL, wake time, midpoint of sleep, and total sleep time (change from baseline), as measured by actigraphy., To assess the effects of 20 mg tasimelteon compared to placebo on subjective sleep-related impairments and subjective sleep disturbances, as measured by PROMIS., To assess the effects of 20 mg tasimelteon compared to placebo on global improvement and severity, as measured by CGI-C, PGI-C, and PGI-S., To assess the effects of 20 mg tasimelteon compared to placebo on the change in circadian phase from baseline to post-treatment, as measured by salivary DLMO., To assess the effects of 20 mg tasimelteon on Sleep Onset (change from baseline) in participants with delayed DLMO compared to participants with non-delayed DLMO, as measured by sleep diary., To assess the effects of 20 mg tasimelteon on Sleep Onset (change from baseline) in participants with PER3 rs57875989 (specifically genotype 4/4 and 4/4+4/5), as measured by sleep diary., To assess the safety and tolerability of a daily single oral dose of 20 mg tasimelteon.

Related papers

No related papers found yet.

Interventions

DRUGHETLIOZ 20 mg hard capsules

DRUGPlacebo will be provided in size and appearance identical to those containing tasimelteon and will be administered orally.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
To assess the effects of a daily single oral dose of 20 mg tasimelteon compared to placebo on Sleep Onset (change from baseline) in participants over a 28-day period, as measured by sleep diary.	—

Secondary

Measure	Time frame
To assess the effects of 20 mg tasimelteon compared to placebo on Sleep Onset (change from baseline) during the treatment phase, as measured by actigraphy., To assess the effects of 20 mg tasimelteon compared to placebo on nighttime subjective sleep parameters such as SOL, wake time, midpoint of sleep, and total sleep time (change from baseline), as measured by sleep diary., To assess the effects of 20 mg tasimelteon compared to placebo on nighttime objective sleep parameters such as SOL, wake time, midpoint of sleep, and total sleep time (change from baseline), as measured by actigraphy., To assess the effects of 20 mg tasimelteon compared to placebo on subjective sleep-related impairments and subjective sleep disturbances, as measured by PROMIS., To assess the effects of 20 mg tasimelteon compared to placebo on global improvement and severity, as measured by CGI-C, PGI-C, and PGI-S., To assess the effects of 20 mg tasimelteon compared to placebo on the change in circadian phase from	—

Measure

Time frame

To assess the effects of 20 mg tasimelteon compared to placebo on Sleep Onset (change from baseline) during the treatment phase, as measured by actigraphy., To assess the effects of 20 mg tasimelteon compared to placebo on nighttime subjective sleep parameters such as SOL, wake time, midpoint of sleep, and total sleep time (change from baseline), as measured by sleep diary., To assess the effects of 20 mg tasimelteon compared to placebo on nighttime objective sleep parameters such as SOL, wake time, midpoint of sleep, and total sleep time (change from baseline), as measured by actigraphy., To assess the effects of 20 mg tasimelteon compared to placebo on subjective sleep-related impairments and subjective sleep disturbances, as measured by PROMIS., To assess the effects of 20 mg tasimelteon compared to placebo on global improvement and severity, as measured by CGI-C, PGI-C, and PGI-S., To assess the effects of 20 mg tasimelteon compared to placebo on the change in circadian phase from

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Countries

Austria, Germany

Outcome results

None listed