NEUROMARK™ System for Rhinitis

(MERIDIEN Trial)

No longer recruiting at 7 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Neurent Medical

Disqualifiers: Active smoker, Pregnancy, Investigational study, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called the NEUROMARK™ System for individuals with chronic rhinitis, a condition causing a constantly stuffy or runny nose. The goal is to evaluate how well this treatment works compared to a sham device. Individuals with long-term stuffy or runny noses who are free of COVID-19 symptoms might be suitable for this study. The trial includes two groups: one receives the real treatment, while the other starts with the sham device and switches to the real treatment after three months. As an unphased trial, this study provides a unique opportunity to investigate a potentially effective treatment for chronic rhinitis.

Will I have to stop taking my current medications?

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

What prior data suggests that the NEUROMARK™ system is safe for treating chronic rhinitis?

Research has shown that the NEUROMARK™ System is generally safe for treating chronic rhinitis. Studies indicate that this device offers a safe and effective treatment option. In one study, patients using the NEUROMARK™ System experienced significant symptom improvement over three months.

The system delivers energy to the nasal area, targeting nasal nerves to reduce symptoms. Non-clinical data support its safety, demonstrating that it functions similarly to other devices already in use.

Overall, the NEUROMARK™ System appears well-tolerated, with no major safety concerns reported in the available research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for chronic rhinitis, such as antihistamines and nasal corticosteroids, focus on reducing inflammation and symptoms temporarily. The NEUROMARK™ System, however, is unique because it uses a targeted radiofrequency ablation technique to disrupt the overactive nerves in the nasal passages that contribute to rhinitis symptoms. This device-based approach could offer long-lasting relief by addressing the root cause of the condition rather than just alleviating symptoms. Researchers are excited about this treatment as it has the potential to provide sustained benefits with a one-time procedure, reducing the need for ongoing medication use.

What evidence suggests that the NEUROMARK™ System is effective for chronic rhinitis?

Research has shown that the NEUROMARK™ System, which participants in this trial may receive, significantly alleviates chronic rhinitis symptoms, such as a runny and stuffy nose. Patients using this treatment experienced substantial improvement in these symptoms just three months after starting. In one study, the average score for nasal symptoms improved by 55% over two years, with 76% of patients experiencing clear benefits. This treatment is minimally invasive, offering a low-risk option that effectively addresses the root causes of chronic rhinitis. ^{4 5 6 7 8}

Who Is on the Research Team?

Annalise Sorensen

Principal Investigator

Neurent Medical

Are You a Good Fit for This Trial?

Inclusion Criteria

Subject provides written informed consent, including authorization to release health information.

Subject has provided a negative pregnancy test (if Subject is a woman of childbearing potential (WOCBP).

Subject WOCBP must be practicing and willing to continue an effective method of birth control during the course of the study.

Exclusion Criteria

If the investigator thinks that you have a physical condition that may prevent you from fully participating in the study or may put you at higher risk, you will not be able to participate.

Subject is pregnant, nursing or plans to become pregnant during the study, or is a WOCBP, but is not willing to use an effective method of birth control.

Patient is enrolled in an investigational drug or device study or has participated in such a study within the last 30 days prior to screening that in the opinion of the Investigator would interfere with the study results

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment with the NEUROMARK device or undergo a sham procedure

3 months

Crossover

Subjects in the sham arm cross over to receive treatment with the NEUROMARK device

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month

What Are the Treatments Tested in This Trial?

Interventions

• NEUROMARK™ System
• Sham Device

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Subject in this arm will undergo treatment with the NEUROMARK device.

Group II: Sham Placebo Group 1 Intervention

Subjects in this arm will undergo the procedure with a Sham device. At 3 months post treatment these subjects will cross over to Arm 1.

Who Is Running the Clinical Trial?

Neurent Medical

Lead Sponsor

Trials

5

Recruited

540+

Published Research Related to This Trial

Current methods for assessing neurotoxicity risk are inadequate, as highlighted by various reports, and there is a need for more biologically based, quantitative procedures that incorporate continuous data and biomarkers.

The symposium discussed enhancing neurotoxicant risk assessments by using benchmark dose approaches and physiologically based pharmacokinetic data, which could lead to more accurate evaluations compared to traditional safety factor methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biologically based, quantitative risk assessment of neurotoxicants. Slikker, W., Crump, KS., Andersen, ME., et al.[2018]

The study emphasizes the urgent need for non-animal-based test methods (NAMs) in developmental neurotoxicity (DNT) testing, highlighting that current in vivo methods are costly and unable to keep up with the number of untested chemicals.

A set of readiness criteria and a preliminary scoring scheme for evaluating 17 NAMs were developed, indicating that several assays are ready for use in prioritizing and screening potential neurotoxic hazards, paving the way for an integrated approach to testing and assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recommendation on test readiness criteria for new approach methods in toxicology: Exemplified for developmental neurotoxicity. Bal-Price, A., Hogberg, HT., Crofton, KM., et al.[2020]

The review emphasizes that the standard Functional Observational Battery (FOB) used for CNS safety assessments can be influenced by factors like multiple post-dose assessments and learning effects, which may compromise the accuracy of the results.

It suggests that combining time- and dose-related behavioral assessments in a single study may not be effective, highlighting the need for more standardized approaches to ensure reliable CNS safety evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repeated "Day 1" FOB testing in ICH S7A safety assessment protocols: The influence of within- and between-session learning. Gauvin, DV., Zimmermann, ZJ., Dalton, JA., et al.[2022]

Citations

1. neuromark.com neuromark.com/resource/new-data-show-neuromark-r-chronic-rhinitis-treatment-offers-significant-symptom-improvements

New Data show NEUROMARK® Chronic Rhinitis ... Patients receiving the NEUROMARK therapy demonstrated significant improvement in rhinorrhea and nasal congestion symptoms at 3 months.

2. neuromark.com neuromark.com/resource/neuromark-r-treatment-for-chronic-rhinitis-demonstrates-durable-2-year-clinical-benefits

NEUROMARK® Treatment for Chronic Rhinitis ... The mean reflective Total Nasal Symptom Score (rTNSS) improved by 55% from baseline at 2 years (p<.0001). 76% of participants achieved the ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10116986/

Clinical evaluation of a novel multipoint radiofrequency ... This is the first published study to evaluate the safety and efficacy of the NEUROMARK System in patients with chronic rhinitis. 2 ...

4. fh-partners.com fh-partners.com/news-entries/2024/9/26/neuromark-treatment-for-chronic-rhinitis-yields-significant-clinical-improvements

NEUROMARK® Treatment for Chronic Rhinitis Yields ... The NEUROMARK® System is a groundbreaking, minimally invasive treatment option designed to target the underlying drivers of chronic rhinitis.

5. neuromark.com neuromark.com/resource/clarity-study-shows-neuromark-r-treatment-benefits-allergic-and-nonallergic-rhinitis-patients

CLARITY Study Shows NEUROMARK® Treatment Benefits ... Explore 12-month safety and efficacy outcomes for treating Chronic Rhinitis with NEUROMARK®.

6. neuromark.com neuromark.com/important-safety-information

Important Safety Information Review important safety information for the NEUROMARK System to ensure optimal outcomes for patients and providers.

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf21/K212666.pdf

October 22, 2021 Neurent Medical Kenny Walsh QA/RA ... The non- clinical data and thermal safety data support substantial equivalence of the NEUROMARK™ System with the predicate device and the ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04769596

NCT04769596 | Safety and Efficacy Study of the Neurent ... The NEUROMARK™ System is designed to deliver energy to the nasal cavity intended to interrupt nasal nerves aimed to reduce symptoms related to Chronic Rhinitis.