What side effects are associated with this type of intervention?

Common treatments for narcolepsy, including norepinephrine reuptake inhibitors like Reboxetine, can cause side effects such as insomnia, dry mouth, dizziness, and increased heart rate. Central nervous system stimulants (e.g., methylphenidate, amphetamines) may lead to increased blood pressure, heart rate, anxiety, and potential for abuse. Wake-promoting agents (e.g., modafinil, armodafinil) can cause headaches, nausea, and anxiety. Sodium oxybate, used for cataplexy and excessive daytime sleepiness, may result in nausea, dizziness, and has a risk of abuse. Antidepressants like venlafaxine can cause sleep disturbances, increased blood pressure, and gastrointestinal issues.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of narcolepsy, focusing on managing excessive daytime sleepiness and cataplexy. Similar to AXS-12 (Reboxetine), which is a norepinephrine reuptake inhibitor, other approved treatments include modafinil and armodafinil, which promote wakefulness. Additionally, sodium oxybate is approved for both excessive daytime sleepiness and cataplexy. Antidepressants such as venlafaxine and fluoxetine are also used off-label to manage cataplexy due to their effects on norepinephrine and serotonin levels.

What other types of research exist?

Promising novel alternatives to AXS-12 (Reboxetine) for narcolepsy patients in 2024 include dual orexin receptor antagonists (DORAs) such as lemborexant and daridorexant. These medications have shown efficacy in treating sleep-related disorders and may offer benefits for managing cataplexy and excessive daytime sleepiness in narcolepsy.

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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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

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

~90

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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.

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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

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

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