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New drug shows promise for Narcolepsy's worst symptoms

NCT ID NCT03881852

Symptom relief Sponsor: Axsome Therapeutics, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 2 trial tested AXS-12 (reboxetine) in 21 adults with narcolepsy and cataplexy. Participants received either the drug or a placebo for three weeks, then switched. The goal was to see if AXS-12 could reduce weekly cataplexy attacks and improve excessive daytime sleepiness.

What this could mean

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

Active substance
AXS-12 (reboxetine)
What this could lead to
If it works, this could point toward a new treatment option to reduce sudden muscle weakness and daytime sleepiness in people with narcolepsy.
What could go wrong
This is a small, early Phase 2 trial with only 21 people and a short 3-week treatment period. Results may not hold up in larger, longer studies, and side effects are possible.

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

21 people

The number who actually took part.

Started

Apr 2019

Finished

Nov 2019

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 70 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.

Key Inclusion Criteria: * Male or female subjects between 18 and 70 years of age, inclusive * Primary diagnosis of narcolepsy with cataplexy * Willing and able to comply with the study requirements Exclusion Criteria: * Other clinically significant conditions potentially causing EDS * Clinically significant psychiatric disorders

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Conditions

The condition(s) this trial relates to.

Cataplexy Disorders of Excessive Somnolence hypersomnia narcolepsy narcolepsy-cataplexy syndrome

As listed by the trial registrant

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

Cataplexy narcolepsy Excessive sleepiness Narcolepsy

Contacts and locations

Locations

  • CONCERT Study Site

    Birmingham, Alabama, 35213, United States

  • CONCERT Study Site

    Alameda, California, 94501, United States

  • CONCERT Study Site

    Santa Ana, California, 92705, United States

  • CONCERT Study Site

    Boulder, Colorado, 80301, United States

  • CONCERT Study Site

    Miami, Florida, 33126, United States

  • CONCERT Study Site

    Gainesville, Georgia, 30501, United States

  • CONCERT Study Site

    Stockbridge, Georgia, 30281, United States

  • CONCERT Study Site

    Fort Wayne, Indiana, 46804, United States

  • CONCERT Study Site

    Chevy Chase, Maryland, 20815, United States

  • CONCERT Study Site

    The Bronx, New York, 10467, United States

  • CONCERT Study Site

    Cincinnati, Ohio, 45219, United States

  • CONCERT Study Site

    Columbia, South Carolina, 29201, United States

  • CONCERT Study Site

    Austin, Texas, 78731, United States

  • CONCERT Study Site

    San Antonio, Texas, 78229, United States

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