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Lemborexant in Delayed Sleep Phase Syndrome

StatusRecruiting
PhasePhase 4
Started2023-03-13
View on ClinicalTrials.gov ↗

Amendment history

2026-06-03
Study Status v3
Re-verified, no change to tracked fields
2025-04-22
Study Status, Eligibility v2
Eligibility criteria-144 characters
[...] stfeeding. Shift workers or subjects working unusual hours. Any risk of suicide within 6 months of screening period or throughout the trial (accessed by the Investigator and by the C-SSRS questionnaire). Transmeridian travel across more than 3 time zones 4 weeks p [...]
2025-03-13
Study Identification, Study Status, Sponsor/Collaborators, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility v1
InterventionsLemborexant (Drug), Placebo (Other)→Lemborexant (Drug), Placebo (Drug)
Eligibility criteria+2 characters
Inclusion Criteria: - Participants will be required to be 18 years of age or older [...]
Secondary endpoints+340 characters
Change in Epworth Sleepiness Scale (ESS) Change in Karolinska Sleepiness Scale (KSS) Change in sleep diary derived sleep onset latency Sleep Regularity Index Change in actigraphy derived total sleep time Change in sleep diary derived total sleep time. Change in mean actigraphy derived wake time Chan [...]
Primary endpoints1 entry, revised
LemborexantChange vsin placeboactigraphy sleep latency onset
Collaborators1 to 2 entries
Stanford University
2025-03-07
Original filing
The purpose of the study is to evaluate whether Lemborexant is more effective than placebo in shortening sleep onset latency in patients with delayed sleep phase syndrome (both type 1 and type 2). This will be tracked using sleep logs as well as actigraphy. In this 2-year study, the investigators will examine if Lemborexant administered 5-10 mg nightly taken at desired bedtime (at least 2 hours prior to self-reported sleep onset habitual time) can improve the symptoms of Delayed Sleep Phase Syndrome.
Trial Details
NCT Number NCT06874855
Lead Sponsor University of California, San Francisco
Collaborators: Eisai Co., Ltd., Stanford University
Conditions Delayed Sleep Phase Syndrome
Enrollment 15 participants
Start Date 2023-03-13
Primary Completion 2027-05-31 (estimated)
Study Completion 2027-05-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-05