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Orexin Antagonist
Lemborexant for Delayed Sleep Phase Syndrome
Phase 4
Recruiting
Led By Emmanuel Mignot, MD, PhD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 2 weeks prior to randomization to 4 weeks post randomization
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
Summary
This trial will compare the efficacy of Lemborexant versus Placebo in patients with Delayed Sleep Phase Syndrome.
Who is the study for?
Adults diagnosed with Delayed Sleep Phase Syndrome (DSPS), where sleep is delayed by two hours or more beyond their desired bedtime, causing social impact. Participants must be willing to comply with the study protocol and keep medication dosages fixed throughout the trial. Exclusions include drug use, significant effects on sleep from other medications, certain medical conditions including depression and anxiety disorders, pregnancy, unusual work hours, recent transmeridian travel, and impaired liver function.
What is being tested?
The trial tests if Lemborexant (5-10 mg nightly) helps people with DSPS fall asleep faster compared to a placebo. Over two years, participants will take the drug at least 2 hours before their habitual sleep onset time. Effectiveness will be measured using sleep logs and actigraphy—a method that tracks movement to assess sleep patterns.
What are the potential side effects?
While specific side effects for this trial are not listed here, common side effects of Lemborexant may include drowsiness during waking hours, headache, flu-like symptoms such as body aches or fever; some people might experience unusual dreams or nightmares.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from 2 weeks prior to randomization to 4 weeks post randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 2 weeks prior to randomization to 4 weeks post randomization
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Actigraphy
Secondary study objectives
Change in Epworth Sleepiness Scale (ESS)
Change in Karolinska Sleepiness Scale (KSS)
Actigraphy
+5 moreAwards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: LemborexantActive Control1 Intervention
Patients receive Lemborexant 5mg for 7 days and may be dose adjusted to 10mg. Patients continue to take Lemborexant 5mg or 10 mg for an additional 7 days.
Group II: PlaceboPlacebo Group1 Intervention
Patients receive placebo to match Lemborexant for 14 days.
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,475 Previous Clinical Trials
17,501,403 Total Patients Enrolled
University of California, San FranciscoOTHER
2,588 Previous Clinical Trials
14,900,947 Total Patients Enrolled
Emmanuel Mignot, MD, PhDPrincipal InvestigatorStanford University
2 Previous Clinical Trials
80 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have no symptoms or test results that need medical treatment.My condition is affecting my daily life and social interactions.My liver enzymes are higher than normal.I am not taking sleep-affecting meds or have stopped them 5 half-lives ago. I may be on stable antidepressants without severe depression or anxiety.I can't fall asleep if I try to sleep before my usual bedtime.My condition is affecting my daily life or social interactions.My heart's electrical activity, measured by QTcF, is over 450 ms.I am 18 years old or older.I have not used any CYP3A affecting drugs for at least a week before starting the trial.I am taking other medications, but I can keep the doses the same during the study.I have been diagnosed with DSPS, meaning I fall asleep much later than I want to.Your bedtime is two hours or more later than what most people consider a regular bedtime.I am 18 years old or older.You are willing and able to comply with all aspects of the protocol.I can't fall asleep if I try to sleep before my usual bedtime.I can keep my medication doses constant during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Lemborexant
- Group 2: Placebo
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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