New drug shows promise for Narcolepsy's worst symptoms

NCT ID NCT03881852

Completed Symptom relief Sponsor: Axsome Therapeutics, Inc. Source: ClinicalTrials.gov ↗

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.

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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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