AXS-12 for Narcolepsy

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

68 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug AXS-12 (reboxetine) for narcolepsy?

A pilot study suggests that reboxetine may have stimulant and anticataplectic effects, which could help manage symptoms of narcolepsy like excessive daytime sleepiness and cataplexy. ^{1 2 3 4 5}

Is AXS-12 (reboxetine) safe for humans?

A pilot study investigated the effects of reboxetine in patients with narcolepsy, but specific safety data from this study is not detailed in the available information. ^{1 5 6 7 8}

How is the drug AXS-12 (reboxetine) different from other narcolepsy treatments?

AXS-12 (reboxetine) is unique because it is a selective norepinephrine reuptake inhibitor, which means it works by increasing norepinephrine levels in the brain to help manage symptoms of narcolepsy. This mechanism is different from many existing treatments that focus on other neurotransmitters or have broader effects. ^{1 5 8 9 10}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Stimulant and anticataplectic effects of reboxetine in patients with narcolepsy: a pilot study. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy of once-nightly sodium oxybate (FT218) in narcolepsy type 1 and type 2: post hoc analysis from the Phase 3 REST-ON Trial. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Narcolepsy: treatment issues. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Narcolepsy: pathophysiology and pharmacology. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Recent advances in the treatment of narcolepsy. [2021]

6. China pubmed.ncbi.nlm.nih.gov

[Clinical effect of atomoxetine hydrochloride in 66 children with narcolepsy]. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the abuse potential of pitolisant, a selective H3-receptor antagonist/inverse agonist, for the treatment of adult patients with narcolepsy with or without cataplexy. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

pitolisant, a novel histamine-3 receptor competitive antagonist, and inverse agonist, in the treatment of excessive daytime sleepiness in adult patients with narcolepsy. [2022]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Recently Approved and Upcoming Treatments for Narcolepsy. [2021]

10. New Zealand pubmed.ncbi.nlm.nih.gov

New developments in the management of narcolepsy. [2020]