AXS-12 for Narcolepsy

(SYMPHONY Trial)

No longer recruiting at 47 trial locations

Overseen By Study Director

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Axsome Therapeutics, Inc.

Disqualifiers: Other EDS conditions, Psychiatric disorders

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

Duration: 5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called AXS-12 to determine its safety and effectiveness for people with narcolepsy, a sleep disorder causing sudden muscle weakness (cataplexy) and extreme tiredness during the day (excessive daytime sleepiness). The study compares AXS-12 to a placebo (a pill with no active ingredient) over five weeks. Individuals diagnosed with narcolepsy and experiencing cataplexy might be suitable for the trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment for narcolepsy.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that AXS-12, also known as reboxetine, has been generally well-tolerated in past studies, with no new safety issues or serious side effects identified. The safety record has remained consistent over long-term use, with side effects similar to those previously observed.

Reboxetine is not recommended for children and teenagers under 18. However, in adults, it demonstrated a good safety record in previous trials. This suggests that AXS-12 could be a promising option for people with narcolepsy, especially given its positive track record in past research. ^{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 include sodium oxybate or modafinil, AXS-12 (reboxetine) is unique because it targets the norepinephrine system. This mechanism helps regulate sleep-wake cycles, potentially offering a new way to manage symptoms. Researchers are excited about AXS-12 because it could provide an effective alternative with a different side effect profile, offering new hope for patients who don't respond well to existing options.

What evidence suggests that AXS-12 could be an effective treatment for narcolepsy with cataplexy and excessive daytime sleepiness?

Research has shown that AXS-12 (reboxetine), which participants in this trial may receive, may help treat narcolepsy, particularly symptoms like sudden muscle weakness (cataplexy) and excessive daytime sleepiness. Studies have found that AXS-12 significantly reduces the number of weekly cataplexy attacks compared to a placebo. In one study, patients experienced fewer cataplexy episodes after just five weeks of treatment. Additionally, when patients switched from AXS-12 to a placebo, their symptoms worsened, highlighting the treatment's potential effectiveness. These results suggest that AXS-12 could be a helpful option for managing narcolepsy symptoms. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

Inclusion Criteria

The patient has a primary diagnosis of narcolepsy with cataplexy

, patients are likely to be included in the study

You are male or female, aged between 15 and 75 years, inclusive.

Exclusion Criteria

You have other medical conditions that may cause excessive daytime sleepiness (EDS).

You have a mental health condition that could affect your ability to participate in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either AXS-12 or placebo for the treatment of cataplexy and excessive daytime sleepiness

5 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

How Is the Trial Designed?

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

Up to 5 weeks

Group II: Placebo Placebo Group 1 Intervention

Up to 5 weeks

Who Is Running the Clinical Trial?

Axsome Therapeutics, Inc.

Lead Sponsor

Trials

34

Recruited

11,600+

Published Research Related to This Trial

A review of 99 completed allergic rhinitis trials found that while adverse events (AEs) were fully reported in ClinicalTrials.gov, only 46.7% of corresponding publications provided complete AE reporting, highlighting a significant gap in transparency.

Inconsistencies were prevalent in 95.6% of the publications, with discrepancies in the number and types of AEs reported, indicating a need for improved reporting standards to enhance patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting of the safety from allergic rhinitis trials registered on ClinicalTrials.gov and in publications: An observational study. Paladin, I., Pranić, SM.[2022]

A survey of 140 professionals with vaccine trial experience revealed significant inconsistencies in assessing whether serious adverse events (SAEs) were related to immunizations, with only 28% of respondents linking leukaemia to a live RSV vaccine, while 74% linked juvenile idiopathic arthritis (JIA) to a group A streptococcal vaccine.

The type of classification system used (two options vs. three options) significantly affected the likelihood of classifying SAEs as related to immunization, highlighting the need for standardized SAE classification systems across clinical trials to improve consistency in pharmacovigilance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors affecting the causality assessment of adverse events following immunisation in paediatric clinical trials: An online survey. Voysey, M., Tavana, R., Farooq, Y., et al.[2017]

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. 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 ...

5. axsometherapeuticsinc.gcs-web.com axsometherapeuticsinc.gcs-web.com/node/11721/pdf

Axsome Therapeutics Announces AXS-12 Achieves Primary ... A significantly greater proportion of patients randomized to switch to placebo reported worsening of their narcolepsy, as assessed by the PGI-C, ...

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 ...

7. db.cbg-meb.nl db.cbg-meb.nl/veegactie/csp/REBOXETINE_Jan2012.pdf

EDRONAX, REBOXETINE Pharmaceutical form(s)/strength Use in children and adolescents under 18 years of age. Reboxetine should not be used in the treatment of children and adolescents under the age of 18 years.