Safety and Efficacy Study of the Neurent Medical NEUROMARK™ System in Subjects With Chronic Rhinitis
(MERIDIEN Trial)
Recruiting at 7 trial locations
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Neurent Medical
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Trial Summary
What is the purpose of this trial?
This trial is testing the NEUROMARK™ System, a device for treating people with chronic rhinitis. It aims to help those who have ongoing symptoms by using electrical signals to reduce inflammation in the nose.
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 safety data exists for the NEUROMARK™ System and related treatments?
Research Team
AS
Annalise Sorensen
Principal Investigator
Neurent Medical
Eligibility Criteria
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.
See 3 more
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
See 3 more
Timeline
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
Treatment Details
Interventions
- NEUROMARK™ System
- Sham Device
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TreatmentExperimental Treatment1 Intervention
Subject in this arm will undergo treatment with the NEUROMARK device.
Group II: ShamPlacebo Group1 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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Neurent Medical
Lead Sponsor
Trials
5
Recruited
540+
Findings from Research
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 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]
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]
References
Assessing the predictive value of the rodent neurofunctional assessment for commonly reported adverse events in phase I clinical trials. [2017]
Biologically based, quantitative risk assessment of neurotoxicants. [2018]
Repeated "Day 1" FOB testing in ICH S7A safety assessment protocols: The influence of within- and between-session learning. [2022]
Qualitative analysis of actual Standard for Exchange of Nonclinical Data (SEND) datasets for Data Domains: Proposition from Japan Pharmaceutical Manufacturers Association SEND Taskforce Team on standardization of nonclinical data. [2021]
Recommendation on test readiness criteria for new approach methods in toxicology: Exemplified for developmental neurotoxicity. [2020]
Other People Viewed
By Subject
By Trial
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.