Status:
RECRUITING
Lemborexant in Delayed Sleep Phase Syndrome
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Eisai Co., Ltd.
Stanford University
Conditions:
Delayed Sleep Phase Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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). Thi...
Detailed Description
Delayed sleep phase syndrome (DSPS) is a disorder in which a person's sleep is delayed by two hours or more beyond what is considered an acceptable or conventional bedtime. The delayed sleep then caus...
Eligibility Criteria
Inclusion
- \- Participants will be required to be 18 years of age or older and have delayed sleep phase syndrome (DSPS). Questionnaires will be used to identify potential confounders and to confirm a potential diagnosis of DSPS based on ICSD3 criteria: a) Sleep is delayed by two hours or more beyond what is considered an acceptable or conventional bedtime for the subject (their desired bedtime). b) Subjects not able to fall asleep if trying to sleep before the later bedtime; c) This is interfering with their wishes/having a social impact. Concomitant medications will be allowed, though dosages will be required to remain fixed throughout participation in the study. The participant also needs to be willing and able to comply with all aspects of the protocol.
Exclusion
- 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.
- Shift workers or subjects working unusual hours.
- Transmeridian travel across more than 3 time zones 4 weeks prior to the screening phase.
- Transmeridian travel across more than 2 time zones during this trial (including the screening phase).
- Having a positive drug test or being unwilling to refrain from using illegal drugs or marijuana during this trial.
- Any clinically abnormal symptom or organ impairment found by medical history at Screening or Baseline and physical examinations, vital signs, or laboratory test results that require medical treatment.
- Impaired liver function (values for enzymes aspartate transaminase (AST) and alanine transaminase (ALT) \> 1.5 times the Upper Limit of Normal).
- Known to be human immunodeficiency virus positive.
Key Trial Info
Start Date :
March 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2027
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06874855
Start Date
March 13 2023
End Date
May 31 2027
Last Update
April 24 2025
Active Locations (1)
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1
University of California San Francisco
San Francisco, California, United States, 94107