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Norepinephrine Reuptake Inhibitor

AXS-12 (reboxetine) for Narcolepsy (SYMPHONY Trial)

Phase 3
Recruiting
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 change from baseline to week 5
Awards & highlights

SYMPHONY Trial 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.

Eligible Conditions
  • Narcolepsy
  • Cataplexy
  • Excessive Daytime Sleepiness

SYMPHONY Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to week 5
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to week 5 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency of cataplexy attacks
Secondary outcome measures
Average weekly frequency of concentration
Average weekly frequency of inadvertent naps

SYMPHONY Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AXS-12 (reboxetine)Experimental Treatment1 Intervention
Up to 5 weeks
Group II: PlaceboPlacebo Group1 Intervention
Up to 5 weeks

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial have an upper age limit?

"This study includes individuals that are aged 15 to 75 years old."

Answered by AI

What is the projected sample size for this clinical trial?

"That is accurate. The clinicaltrials.gov website has information indicating that this research is currently looking for 43 different sites to enroll a total of 90 patients."

Answered by AI

What is the historical record of AXS-12 in medical research?

"The research and development of AXS-12 (reboxetine) was originally conducted in 2008 at Parc Sanitari Sant Joan de Déu. As of now, there are 18,245 completed studies. Out of the 5 active clinical trials, a large number are based in Williamsburg, Virginia."

Answered by AI

Has AXS-12 (reboxetine) been authorized by the FDA?

"There is some evidence that AXS-12 (reboxetine) is effective, and multiple studies have shown that it is safe, so our team at Power gave it a score of 3."

Answered by AI

Could I be a part of this research if I wanted to be?

"Eligible patients for this study must have a diagnosis of narcolepsy and be between 15-75 years old. Around 90 patients will be admitted in total."

Answered by AI

Who else is applying?

What state do they live in?
South Carolina
Other
New York
Texas
How old are they?
18 - 65
What site did they apply to?
Clinical Research Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
3+

Why did patients apply to this trial?

I'm having trouble finding a medication that works for me. I'm in a seemingly endless downward spiral with less and less hope for my existence.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

How long is the expected time of the trial? Is there housing included with the trial? How often will I be expected to be on site during the trial or do you offer virtual visits in this trial?
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy
2021. "A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05059223.
All > Narcolepsy
~25 spots leftby Apr 2025
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