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Lemborexant in Delayed Sleep Phase Syndrome

ConditionDelayed Sleep Phase Syndrome
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

Clinically significant depression (PHQ-9 score of 10 or more), anxiety disorder (GAD- 7 score of 10 or more), substance use disorder, any other sleep disorder, or any medical disorder/therapy that could interfere with the trial

Use of medications with significant effects on sleep-wake function (insomnia therapies, stimulants)- unless they are discontinued at least 5 half-lives prior to study participation. Non-sedative antidepressants or SSRI will be allowed if at a stable dose in the absence of concomitant severe depression or severe anxiety.

Use of CYP3A inhibitors and CYP3A inducers, at least 1 week (or five half-lives, whichever is longer) prior to the first day of the baseline phase.

Pregnancy (verified by urine pregnancy test on visits 1, 2, and 3) or plan to become pregnant in the next 3 months or currently breastfeeding.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lemborexant

    Drug

    Lemborexant tablet administered orally once daily

  • Placebo

    Drug

    Placebo to match Lemborexant tablet administered orally once daily

Treatment groups

15 Participants
are divided into 2 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: LemborexantActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in actigraphy sleep latency onset

Sleep latency is the time from laying down until falling asleep. Actigraphy data obtained using Axivity- AX6.

Time frame
From 2 weeks prior to randomization to 4 weeks post randomization

Secondary outcomes

1

Change in Epworth Sleepiness Scale (ESS)

This is a scale to evaluate daytime sleepiness. Range from 0 to 24 points (higher scores mean more sleepiness).

Time frame
From randomization to 4 weeks post randomization
2

Change in Karolinska Sleepiness Scale (KSS)

Self-report for daytime sleepiness with 1 being extremely alert and 10 being extremely sleepy, can't keep awake.

Time frame
From randomization to 4 weeks post randomization
3

Change in sleep diary derived sleep onset latency

Sleep latency is the time from laying down until falling asleep as estimated by patient in dairy.

Time frame
From 2 weeks prior to randomization to 4 weeks post randomization
4

Sleep Regularity Index

Sleep Regularity Index is defined as the percentage probability of a person being asleep (or awake) at any two time points 24 hours apart. Actigraphy data obtained using Axivity- AX6.

Time frame
From 2 weeks prior to randomization to 4 weeks post randomization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

Eisai Co., Ltd.

Collaborator

Stanford University

Collaborator

Source ClinicalTrials.gov
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