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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 5 years
Awards & highlights
Pivotal Trial

Summary

This trial tests AXS-12, a medication for people with narcolepsy who have sudden muscle weakness and trouble staying awake. It aims to see if AXS-12 can help by balancing brain chemicals to improve wakefulness and reduce muscle weakness.

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.
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.
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 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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 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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AXS-12 (reboxetine)
2021
Completed Phase 3
~160

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for narcolepsy work by targeting different neurotransmitter systems to alleviate symptoms like excessive daytime sleepiness (EDS) and cataplexy. Norepinephrine reuptake inhibitors, such as Reboxetine, increase norepinephrine levels in the brain, which helps reduce cataplexy and improve wakefulness. Modafinil, a wake-promoting agent, primarily affects dopamine and norepinephrine pathways to enhance alertness. Antidepressants, including SSRIs and tricyclics, suppress REM sleep and reduce cataplexy by increasing serotonin and norepinephrine levels. Oxybates, like sodium oxybate, improve nighttime sleep and reduce daytime sleepiness and cataplexy by modulating GABA receptors. These mechanisms are essential for tailoring treatment to individual patient needs, improving overall quality of life for those with narcolepsy.
Fluvoxamine and clomipramine in the treatment of cataplexy.[Wake disorders. I. Primary wake disorders].The acute effects of the noradrenaline reuptake inhibitor Org 4428 on EEG sleep in healthy volunteers.

Find a Location

Who is running the clinical trial?

Axsome Therapeutics, Inc.Lead Sponsor
32 Previous Clinical Trials
10,987 Total Patients Enrolled
4 Trials studying Narcolepsy
1,848 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
~16 spots leftby Dec 2025