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Norepinephrine Reuptake Inhibitor

A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy (SYMPHONY Trial)

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 change from baseline to week 5
Awards & highlights
Pivotal Trial

Summary

This trial tests AXS-12, a medication for people with narcolepsy who have sudden muscle weakness and excessive daytime sleepiness. It aims to help them stay awake during the day and reduce muscle weakness episodes. Pitolisant is a new drug approved to treat excessive daytime sleepiness and cataplexy in narcolepsy.

Eligible Conditions
  • Narcolepsy
  • Cataplexy
  • Hereditary Angioedema
  • Hypersomnia

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Frequency of cataplexy attacks
Secondary study objectives
Average weekly frequency of concentration
Average weekly frequency of inadvertent naps

Awards & Highlights

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 5 weeks
Group II: PlaceboPlacebo Group1 Intervention
Up to 5 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AXS-12 (reboxetine)
2021
Completed Phase 3
~90

Find a Location

Who is running the clinical trial?

Axsome Therapeutics, Inc.Lead Sponsor
31 Previous Clinical Trials
10,837 Total Patients Enrolled
4 Trials studying Narcolepsy
1,848 Patients Enrolled for Narcolepsy
~21 spots leftby Dec 2025
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