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Norepinephrine Reuptake Inhibitor

AXS-12 for Narcolepsy

Phase 3
Waitlist Available
Research Sponsored by Axsome Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 28 weeks
Awards & highlights

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.

Who is the study for?
This trial is for people with narcolepsy who experience sudden muscle weakness (cataplexy) and excessive daytime sleepiness. Participants must have completed the AXS-12-301 study without significant changes in their health or medications that would affect their suitability for this trial.Check my eligibility
What is being tested?
The study tests the long-term effects of a drug called AXS-12 (reboxetine) on narcolepsy symptoms, specifically cataplexy and excessive daytime sleepiness. It compares AXS-12 to a placebo to see if it's effective and safe over an extended period.See study design
What are the potential side effects?
Possible side effects of AXS-12 may include dry mouth, constipation, trouble sleeping, increased heart rate, blood pressure changes, dizziness upon standing up too fast, and urinary retention.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 28 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 28 weeks for reporting.

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

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 Location

Who is running the clinical trial?

Axsome Therapeutics, Inc.Lead Sponsor
28 Previous Clinical Trials
8,102 Total Patients Enrolled
3 Trials studying Narcolepsy
117 Patients Enrolled for Narcolepsy

Media Library

AXS-12 (reboxetine) (Norepinephrine Reuptake Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05113745 — Phase 3
Narcolepsy Clinical Trial 2023: AXS-12 (reboxetine) Highlights & Side Effects. Trial Name: NCT05113745 — Phase 3
AXS-12 (reboxetine) (Norepinephrine Reuptake Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05113745 — Phase 3
Narcolepsy Research Study Groups: Placebo, AXS-12 (reboxetine)
Narcolepsy Patient Testimony for trial: Trial Name: NCT05113745 — Phase 3

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.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects With Narcolepsy
2021. "A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects With Narcolepsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05113745.
All > Narcolepsy
~17 spots leftby Dec 2024
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