Lemborexant for Night Owl Syndrome

(Eisai DSPS Trial)

Overseen By Andrew D Krystal, MD, MS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of California, San Francisco

Must not be taking: Insomnia therapies, Stimulants, CYP3A drugs

Disqualifiers: Depression, Anxiety, Substance use, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

15 Participants Needed

Trial Summary

What is the purpose of 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.

Research Team

Andrew D Krystal, MD, MS

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for individuals with Delayed Sleep Phase Syndrome, often called 'Night owl syndrome', where they have trouble falling asleep at conventional times. Participants should be willing to take medication nightly and maintain sleep logs.

Inclusion Criteria

Participants must be willing and able to comply with all aspects of the protocol

I am 18 or older with delayed sleep phase syndrome.

Questionnaires will be used to confirm a potential diagnosis of DSPS based on ICSD3 criteria

Exclusion Criteria

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

Shift workers or subjects working unusual hours

Any risk of suicide within 6 months of screening period or throughout the trial

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Lemborexant 5mg for 7 days, with possible dose adjustment to 10mg, or placebo for 14 days

2 weeks

Follow-up

Participants are monitored for changes in sleep onset latency, sleep regularity, and other sleep parameters using sleep diaries and actigraphy

4 weeks

Long-term monitoring

Participants continue to be monitored for long-term effects of treatment over the 2-year study period

2 years

Treatment Details

Interventions

• Lemborexant

Trial Overview The study tests if Lemborexant helps people with Delayed Sleep Phase Syndrome fall asleep faster compared to a placebo. It's a 2-year study where participants take the drug or placebo at their desired bedtime, which is earlier than usual.

Participant Groups

Group I: Lemborexant Active Control 1 Intervention

Patients receive Lemborexant 5mg for 7 days and may be dose adjusted to 10mg. Patients continue to take Lemborexant 5mg or 10mg for an additional 7 days

Group II: Placebo Placebo Group 1 Intervention

Patients receive placebo to match Lemborexant for 14 days

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

Eisai Co., Ltd.

Industry Sponsor

Trials

182

Recruited

660,000+

Lynn Kramer

Eisai Co., Ltd.

Chief Medical Officer since 2019

MD from the University of Tokyo

Haruo Naito

Eisai Co., Ltd.

Chief Executive Officer since 1988

Bachelor's degree in Economics from Keio University