Recruiting

Testing a new medication to reduce daytime sleepiness in narcolepsy

Plain-English translation of NCT07540364 on ClinicalTrials.gov ↗ · Source last updated September 2026 · Translation generated September 2026 · How we translate trials

Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.

What is this trial?

This is a Phase 3 clinical trial testing a new medication called to help reduce excessive daytime sleepiness in adults with narcolepsy (a condition that causes uncontrollable sleep attacks). You would receive either the medication or a placebo (a look-alike pill with no active ingredient) for 12 weeks, and researchers would measure how well it helps you stay awake during the day. Neither you nor the study team would know which pill you're taking until the study ends.

Narcolepsy causes overwhelming daytime sleepiness that significantly impacts quality of life and safety. Researchers are testing this medication to see if it can offer people with narcolepsy a new treatment option to help them stay alert during the day.

Do you qualify?

You likely qualify if…

you are 18 years old or older
you have been diagnosed with narcolepsy (with or without cataplexy) based on sleep study results
you have excessive daytime sleepiness, even if you're already taking some narcolepsy treatments
you are willing to stop taking other narcolepsy medications for 2 weeks before the study begins
you have a normal sleep schedule and can commit to keeping a sleep diary during the screening period

You likely don't qualify if…

you have active alcohol or drug use disorder in the past 3 months
you are currently taking other medications for cataplexy (such as certain antidepressants or sodium oxybate)
you have a heart rhythm condition or abnormal ECG results
you work night shifts, have variable work schedules, or travel across multiple time zones during the study
you consume excessive caffeine (more than 600 mg per day, equivalent to about 6 cups of coffee)

What participation looks like

You would visit the study center at baseline and then receive either tablets or matching placebo tablets to take daily for 12 weeks. During the study, you'll have clinic visits where researchers test how alert you are using standard sleep tests, and you'll keep a sleep diary to track your sleep patterns. The entire study lasts about 12 weeks, and your participation helps researchers determine whether this medication is safe and effective for treating excessive daytime sleepiness in narcolepsy.

AI-generated summary from trial data · Sep 5, 2026 · Not medical advice

Trial locations(1 site)

United States

Bogan Sleep Consultants, Columbia, South Carolina