AXS-12 for Narcolepsy

No longer recruiting at 28 trial locations

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Axsome Therapeutics, Inc.

Disqualifiers: Significant medical history change, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called AXS-12 (reboxetine, a type of antidepressant) to determine its effectiveness and safety for people with narcolepsy who experience cataplexy (sudden muscle weakness) and excessive daytime sleepiness. Participants will receive either AXS-12 or a placebo to compare results. The trial is open to those who completed a prior study with AXS-12 and can adhere to the study's guidelines. As a Phase 3 trial, this is the final step before FDA approval, offering participants a chance to contribute to potentially bringing a new treatment to market.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if there has been a significant change in your medications since the previous study, it might affect your eligibility.

Is there any evidence suggesting that AXS-12 (reboxetine) is likely to be safe for humans?

Research shows that AXS-12, also known as reboxetine, may help treat narcolepsy. In earlier studies, patients generally tolerated AXS-12 well, and researchers found no serious safety issues. Common side effects included dry mouth and nausea, but these were mild. No unexpected problems appeared during the trials.

This trial of AXS-12 is in a late stage, indicating that a lot of safety information is already available. For those considering joining the trial, existing research suggests that AXS-12 is generally safe. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for narcolepsy?

Unlike the standard treatments for narcolepsy, which often involve stimulants like modafinil or sodium oxybate, AXS-12 (reboxetine) acts uniquely as a norepinephrine reuptake inhibitor. This mechanism targets the norepinephrine system to potentially improve wakefulness and reduce cataplexy episodes, offering a different approach from traditional stimulant-based therapies. Researchers are excited about AXS-12 because it might offer a new option with potentially fewer side effects and a different safety profile compared to existing medications.

What evidence suggests that AXS-12 might be an effective treatment for narcolepsy?

Research has shown that AXS-12 (reboxetine), which participants in this trial may receive, holds promise for treating narcolepsy, particularly in reducing cataplexy attacks. Studies have found that AXS-12 significantly lowers the number of weekly cataplexy attacks compared to a placebo, resulting in fewer episodes of sudden muscle weakness. Additionally, AXS-12 effectively manages excessive daytime sleepiness, a common symptom of narcolepsy. Overall, the evidence supports AXS-12 as an effective option for managing narcolepsy symptoms. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Completed the treatment period of Study AXS-12-301

Willing and able to comply with the study requirements

Exclusion Criteria

Significant change in medical history or concomitant medications since enrolling in the AXS-12-301 study which, in the opinion of the Investigator, would render the subject unsuitable to receive AXS-12

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Open-label Treatment

Participants receive AXS-12 (reboxetine) for 24 weeks

24 weeks

Randomized Withdrawal

Participants are randomized to continue AXS-12 or switch to placebo for 4 weeks

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AXS-12 (reboxetine)

Trial Overview 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.

How Is the Trial Designed?

Group I: AXS-12 (reboxetine) Experimental Treatment 1 Intervention

* Up to 24 weeks in open-label period * Up to 4 weeks in randomized double-blind period

Group II: Placebo Placebo Group 1 Intervention

Up to 4 weeks in randomized double-blind period

Who Is Running the Clinical Trial?

Axsome Therapeutics, Inc.

Lead Sponsor

Trials

34

Recruited

11,600+

Published Research Related to This Trial

Narcolepsy affects a small percentage of the population and is linked to genetic factors and the loss of hypocretin-producing neurons, suggesting an autoimmune component that may be triggered by environmental factors.

Current treatments like sodium oxybate and modafinil effectively manage symptoms such as excessive daytime sleepiness and cataplexy, while emerging therapies focus on both non-hypocretin-based and hypocretin-based approaches to improve outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New developments in the management of narcolepsy. Abad, VC., Guilleminault, C.[2020]

Atomoxetine hydrochloride was effective in reducing excessive daytime sleepiness, cataplexy, and night sleep disorders in children with narcolepsy, with 62 out of 66 patients showing improvement over an average follow-up of 18 months.

The treatment was generally well-tolerated with mild adverse effects, such as anorexia and mood disorders, making atomoxetine a safe and non-addictive alternative for managing narcolepsy in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical effect of atomoxetine hydrochloride in 66 children with narcolepsy]. Zhang, S., Ding, C., Wu, H., et al.[2018]

Citations

1. neurology.org neurology.org/doi/10.1212/WNL.0000000000208585

AXS-12 for the Treatment of Narcolepsy: Topline Results ... AXS-12 met its primary endpoint, leading to a substantial, statistically significant reduction in weekly cataplexy attacks.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05113745

NCT05113745 | A Study to Assess the Long-term Efficacy ... This study will evaluate the long-term efficacy and safety of AXS-12 in narcoleptic subjects with cataplexy and excessive daytime sleepiness (EDS). Detailed ...

3. academic.oup.com academic.oup.com/sleep/article/48/Supplement_1/A365/8135759

0843 ENCORE: Topline Results of a Phase 3 Open-Label ... AXS-12 significantly reduced weekly cataplexy attacks from baseline to Week 5 versus placebo in patients with narcolepsy.

4. neurologyadvisor.com neurologyadvisor.com/reports/axs-12-narcolepsy-effective-cataplexy-attacks-phase-3-trial/

AXS-12 for Narcolepsy Effective in Reducing Cataplexy ... Among patients with narcolepsy, AXS-12 (reboxetine) vs placebo significantly reduced the frequency of cataplexy attacks.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05059223

A Study to Assess the Efficacy and Safety of AXS-12 ... This study is a multi-center, double-blind, placebo-controlled, randomized Phase 3 trial to assess the safety and efficacy of AXS-12 in narcoleptic subjects ...

6. axsome.com axsome.com/wp-content/uploads/2024/11/SLEEP-Poster_2020-Final.pdf

Efficacy and Safety of AXS-12 in the Treatment of Narcolepsy Data are mean (SD) unless otherwise stated. • Baseline disease severity represents patients with a confirmed diagnosis of narcolepsy with cataplexy. Rapid ...