NCT05463861 Lemborexant in Delayed Sleep Phase Syndrome
| NCT ID | NCT05463861 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Stanford University |
| Condition | Delayed Sleep Phase Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 86 participants |
| Start Date | 2022-02-01 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 86 participants in total. It began in 2022-02-01 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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, we 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
Inclusion Criteria: 1. 18 years of age or older. 2. Diagnosed with delayed sleep phase syndrome (DSPS) meaning that: 1. Sleep is delayed by two hours or more beyond what is considered an acceptable or conventional bedtime for the subject (their desired bedtime). 2. Subjects not able to fall asleep if trying to sleep before the later bedtime; 3. This is interfering with their wishes/having social impact. 3. Concomitant medications will be allowed, though dosages will be required to remain fixed throughout participation in the study. 4. The participant also needs to be willing and able to comply with all aspects of the protocol. Exclusion Criteria: 1. 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 (assessed by the Alliance Sleep Questionnaire- ASQ), or any medical disorder/therapy that could interfere with the trial (this will be verified through interview and analysis of the ASQ). 2. 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. 3. 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. 4. 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. 5. Shift workers or subjects working unusual hours. 6. Any risk of suicide within 6 months of screening period or throughout the trial (accessed by the Investigator and by the C-SSRS questionnaire). 7. Transmeridian travel across more than 3 time zones 4 weeks prior to the screening phase. 8. Transmeridian travel across more than 2 time zones during this trial (including the screening phase). 9. Having a positive drug test or being unwilling to refrain from using illegal drugs or marijuana during this trial. 10. Any clinically abnormal symptom or organ impairment found by medical history at Screening or Baseline and physical examinations, vital signs, ECG findings, or laboratory test results that require medical treatment. 11. Impaired liver function (values for enzymes aspartate transaminase (AST) and alanine transaminase (ALT) \> 1.5 times the Upper Limit of Normal). 12. Known to be human immunodeficiency virus positive. 13. Has a QT interval corrected using Fridericia's formula interval (QTcF interval) \>450 ms demonstrated on repeated ECGs (repeated only if initial ECG showed corrected QT interval (QTc) \>450 ms) at Screening or Baseline.
Contact & Investigator
Emmanuel Mignot, MD, PhD
PRINCIPAL INVESTIGATOR
Stanford University
Frequently Asked Questions
Who can join the NCT05463861 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Delayed Sleep Phase Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05463861 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05463861 currently recruiting?
Yes, NCT05463861 is actively recruiting participants. Visit ClinicalTrials.gov or contact Stanford University to inquire about joining.
Where is the NCT05463861 trial being conducted?
This trial is being conducted at Redwood City, United States, San Francisco, United States.
Who is sponsoring the NCT05463861 clinical trial?
NCT05463861 is sponsored by Stanford University. The principal investigator is Emmanuel Mignot, MD, PhD at Stanford University. The trial plans to enroll 86 participants.