A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy

(SYMPHONY Trial)

Recruiting at 46 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

90 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests AXS-12, a medication for people with narcolepsy who have sudden muscle weakness and excessive daytime sleepiness. It aims to help them stay awake during the day and reduce muscle weakness episodes. Pitolisant is a new drug approved to treat excessive daytime sleepiness and cataplexy in 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.

What safety data exists for the treatment known as AXS-12?

The research articles reviewed do not provide specific safety data for AXS-12 or its evaluations under different names or conditions. ^{1 2 3 4 5}

Eligibility Criteria

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

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

Treatment Details

Interventions

• AXS-12

Participant Groups

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+

Findings from Research

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Assessment of SUSARs. Clinical evaluation of single cases in terms of regulatory requirements]. [2016]

2. Greece pubmed.ncbi.nlm.nih.gov

Adverse Events in Placebo Arms of Cancer Trials. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Factors affecting the causality assessment of adverse events following immunisation in paediatric clinical trials: An online survey. [2017]

4. England pubmed.ncbi.nlm.nih.gov

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

5. Netherlands pubmed.ncbi.nlm.nih.gov

Adverse event assessment methods in published trials of psychotropic drugs: Poor reporting and neglect of emerging safety concerns. [2017]