Norepinephrine Reuptake Inhibitor
AXS-12 (reboxetine) for Narcolepsy
Clinical Research Site, Miami Lakes, FL
Targeting 3 different conditionsAXS-12 (reboxetine) +1 morePhase 3Waitlist AvailableResearch Sponsored by Axsome Therapeutics, Inc.Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must not have
Timeline
Screening 3 weeks
Treatment Varies
Follow Upup to 28 weeks
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial
Study Summary
This trial will study how effective and safe AXS-12 is for people with narcolepsy, specifically those with cataplexy and excessive daytime sleepiness.
Eligible Conditions
- Narcolepsy
- Excessive Daytime Sleepiness
- Cataplexy
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 28 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 28 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy as measured by change in frequency of cataplexy attacks from baseline.
Long-term safety as measured by the incidence of treatment-emergent adverse events
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AXS-12 (reboxetine)Experimental Treatment1 Intervention
Up to 24 weeks in open-label period
Up to 4 weeks in randomized double-blind period
Group II: PlaceboPlacebo Group1 Intervention
Up to 4 weeks in randomized double-blind period
Find a site
Who is running the clinical trial?
Axsome Therapeutics, Inc.Lead Sponsor
25 Previous Clinical Trials
7,400 Total Patients Enrolled
3 Trials studying Narcolepsy
117 Patients Enrolled for Narcolepsy
Media Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who does this study hope to include in its research?
"Up to 90 narcolepsy patients aged 15-75 can participate in this study, pending they are able and willing to follow the study's guidelines."
Answered by AI
If I am older than 45, can I still participate in this clinical research?
"According to the rules that define who can participate in this research, the youngest person that can enroll is 15 years old and the oldest is 75."
Answered by AI
Are there previous examples of AXS-12's (reboxetine) efficacy?
"AXS-12 (reboxetine) was first introduced in 2008 through clinical trials at Parc Sanitari Sant Joan de Déu. Since then, a total of 18,271 trials have been completed. Currently, there are 5 trials recruiting patients with a significant portion based in Charleston, South Carolina."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
What site did they apply to?
Clinical Research Site
Why did patients apply to this trial?
I'm in a seemingly endless downward spiral with less and less hope for my existence.
Patient