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Could a common antibiotic wake up the sleepy brain?

NCT ID NCT04026958

Disease control Sponsor: Emory University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 07, 2026 · Last updated Aug 07, 2026

Summary

This study tests whether clarithromycin, an antibiotic, can reduce excessive daytime sleepiness in people with narcolepsy or idiopathic hypersomnia. Participants receive either clarithromycin or a placebo for 14 days. Researchers will measure changes in sleepiness, brain activity, inflammation, and gut bacteria to understand how the drug might work. The goal is to see if this antibiotic could be a new way to help people stay awake during the day.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Clarithromycin (an antibiotic) taken as 500 mg twice daily for 14 days, compared to placebo.
What this could lead to
If effective, clarithromycin could offer a new treatment option for people with narcolepsy or idiopathic hypersomnia to reduce daytime sleepiness, potentially improving daily functioning.
What could go wrong
This is a phase 2 trial with a relatively small number of participants, so results may not be definitive. The antibiotic may cause side effects like gastrointestinal issues, and its effectiveness for sleepiness is not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

83 people

The number who actually took part.

Started

Sep 2019

Finished

Jun 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * diagnosis of idiopathic hypersomnia or narcolepsy * age 18-60 * free of wake-promoting medication, sleepy despite current wake-promoting medications, or willing to discontinue current wake-promoting medication for at least 5 half-lives prior to baseline measures Exclusion Criteria: * other potential causes of hypersomnolence, including untreated moderate or severe sleep apnea, severe periodic limb movement disorder with arousals, uncontrolled metabolic disorders * contraindication to clarithromycin * contraindication to any of the study procedures

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Conditions

The condition(s) this trial relates to.

idiopathic hypersomnia narcolepsy narcolepsy without cataplexy narcolepsy-cataplexy syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Idiopathic hypersomnia Narcolepsy with cataplexy Narcolepsy without cataplexy

Contacts and locations

Locations

  • Emory Sleep Center

    Atlanta, Georgia, 30329, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.