NCT05113745

Brief Summary

This study will evaluate the long-term efficacy and safety of AXS-12 in narcoleptic subjects with cataplexy and excessive daytime sleepiness (EDS).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2021

Typical duration for phase_3

Geographic Reach
2 countries

25 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2021

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 29, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 9, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2024

Completed
Last Updated

November 13, 2025

Status Verified

November 1, 2025

Enrollment Period

3.1 years

First QC Date

October 29, 2021

Last Update Submit

November 11, 2025

Conditions

NarcolepsyCataplexyExcessive Daytime Sleepiness

Keywords

AXS-12NarcolepsyCataplexyExcessive Daytime SleepinessReboxetineAxsome

Outcome Measures

Primary Outcomes (2)

  • Long-term safety as measured by the incidence of treatment-emergent adverse events

    Up to 28 weeks

  • Efficacy as measured by change in frequency of cataplexy attacks from baseline.

    Baseline to Week 27

Study Arms (2)

AXS-12 (reboxetine)

EXPERIMENTAL

* Up to 24 weeks in open-label period * Up to 4 weeks in randomized double-blind period

Drug: AXS-12 (reboxetine)

Placebo

PLACEBO COMPARATOR

Up to 4 weeks in randomized double-blind period

Drug: Placebo

Interventions

AXS-12 (reboxetine)DRUG

AXS-12 tablets, taken twice daily

AXS-12 (reboxetine)
PlaceboDRUG

Placebo tablets, taken twice daily

Placebo

Eligibility Criteria

Age15 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Completed the treatment period of Study AXS-12-301
  • Willing and able to comply with the study requirements

You may not qualify if:

  • Significant change in medical history or concomitant medications since enrolling in the AXS-12-301 study which, in the opinion of the Investigator, would render the subject unsuitable to receive AXS-12

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Clinical Research Site

Phoenix, Arizona, 85054, United States

Location

Clinical Research Site

Boulder, Colorado, 80301, United States

Location

Clinical Research Site

Colorado Springs, Colorado, 80918, United States

Location

Clinical Research Site

Brandon, Florida, 33511, United States

Location

Clinical Research Site

Clearwater, Florida, 33765, United States

Location

Clinical Research Site

Doral, Florida, 33122, United States

Location

Clinical Research Site

Miami Lakes, Florida, 33016, United States

Location

Clinical Research Site

Winter Park, Florida, 32789, United States

Location

Clinical Research Site

Atlanta, Georgia, 30315, United States

Location

Clinical Research Site

Atlanta, Georgia, 30328, United States

Location

Clinical Research Site

Stockbridge, Georgia, 30281, United States

Location

Clinical Research Site

Chevy Chase, Maryland, 20815, United States

Location

Clinical Research Site

Kalamazoo, Michigan, 49008, United States

Location

Clinical Research Site

Novi, Michigan, 48377, United States

Location

Clinical Research Site

Neptune City, New Jersey, 07753, United States

Location

Clinical Research Site

Denver, North Carolina, 28037, United States

Location

Clinical Research Site

Gastonia, North Carolina, 28054, United States

Location

Clinical Research Site

Huntersville, North Carolina, 28078, United States

Location

Clinical Research Site

Cincinnati, Ohio, 45245, United States

Location

Clinical Research Site

Wyomissing, Pennsylvania, 19610, United States

Location

Clinical Research Site

Charleston, South Carolina, 29425, United States

Location

Clinical Research Site

Columbia, South Carolina, 29201, United States

Location

Clinical Research Site

Austin, Texas, 78731, United States

Location

Clinical Research Site

San Antonio, Texas, 78229, United States

Location

Clinical Research Site

Toronto, Ontario, M5S 3A3, Canada

Location

Related Links

MeSH Terms

Conditions

NarcolepsyCataplexyDisorders of Excessive Somnolence

Interventions

Reboxetine

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

MorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Open-label treatment period, followed by a double-blind treatment period.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2021

First Posted

November 9, 2021

Study Start

October 20, 2021

Primary Completion

November 15, 2024

Study Completion

November 15, 2024

Last Updated

November 13, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(24)CA(1)