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Lemborexant for Delayed Sleep Phase Syndrome
Study Summary
This trial will compare the efficacy of Lemborexant versus Placebo in patients with Delayed Sleep Phase Syndrome.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- 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.
- Group 1: Lemborexant
- Group 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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.
Frequently Asked Questions
What potential hazards should be considered when using Lemborexant?
"Owing to its Phase 4 status, Lemborexant was given a safety rating of 3 by our Power team. This designation denotes that it is an approved treatment for use."
Is this experiment actively recruiting participants?
"Affirmative. Information on clinicaltrials.gov suggests that this research program is currently looking for participants and was initially launched on February 1st 2022. The latest update was made July 14th 2022, with 60 patients needed from one location."
How many people are currently enrolled in this clinical experiment?
"Affirmative. Clinicaltrials.gov lists the trial, which was initially posted on February 1st 2022, as being actively recruiting patients right now. Sixty individuals need to be recruited from a single clinical site in order to complete this study."
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What portion of applicants met pre-screening criteria?
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