AXS-12 (reboxetine) for Narcolepsy

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Clinical Research Site, Sugar Land, TX
Narcolepsy+4 More
AXS-12 (reboxetine) - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new medication for people with narcolepsy who experience sudden muscle weakness (cataplexy) and excessive daytime sleepiness. The goal is to see if the medication is safe and effective. The FDA has approved AXS-12 (reboxetine) to treat narcolepsy. This is the second condition that AXS-12 (reboxetine) has been approved to treat by the FDA.

Eligible Conditions

  • Narcolepsy
  • Excessive Daytime Sleepiness
  • Cataplexy

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Narcolepsy

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: Change from Baseline to Week 5

Week 5
Average weekly frequency of cataplexy attacks
Average weekly frequency of concentration
Average weekly frequency of inadvertent naps
Frequency of cataplexy attacks

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Narcolepsy

Trial Design

2 Treatment Groups

AXS-12 (reboxetine)
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

90 Total Participants · 2 Treatment Groups

Primary Treatment: AXS-12 (reboxetine) · Has Placebo Group · Phase 3

AXS-12 (reboxetine)
Drug
Experimental Group · 1 Intervention: AXS-12 (reboxetine) · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change from baseline to week 5
Closest Location: Clinical Research Site · Sugar Land, TX
Photo of texas 1Photo of texas 2Photo of texas 3
2005First Recorded Clinical Trial
2 TrialsResearching Narcolepsy
19 CompletedClinical Trials

Who is running the clinical trial?

Axsome Therapeutics, Inc.Lead Sponsor
23 Previous Clinical Trials
7,077 Total Patients Enrolled
3 Trials studying Narcolepsy
117 Patients Enrolled for Narcolepsy

Eligibility Criteria

Age Any Age · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are male or female, aged between 15 and 75 years, inclusive.
The patient has a primary diagnosis of narcolepsy with cataplexy
, patients are likely to be included in the study

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.