NEUROMARK System for Movement Disorders
Recruiting in Palo Alto (17 mi)
+15 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Neurent Medical
No Placebo Group
Trial Summary
What is the purpose of this trial?The NEUROMARK RCT Study is a prospective, multicenter, randomized, sham-controlled, single-blinded, superiority trial.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications.
What data supports the idea that NEUROMARK System for Movement Disorders is an effective treatment?
The available research does not provide specific data supporting the effectiveness of the NEUROMARK System for Movement Disorders. The articles focus on other treatments and conditions, such as Parkinson's disease and multiple system atrophy, but do not mention the NEUROMARK System directly. Therefore, there is no direct evidence from the provided information to support the effectiveness of the NEUROMARK System for Movement Disorders.
12345What safety data is available for the NEUROMARK System for Movement Disorders?
The provided research does not contain specific safety data for the NEUROMARK System for Movement Disorders or its related names. The articles focus on general topics such as drug discovery, neurotoxicity biomarkers, nonhuman primate studies, CNS drug delivery techniques, and new approach methodologies in toxicology. None of these directly address the safety data for the NEUROMARK System.
678910Is the NEUROMARK System a promising treatment for movement disorders?
The NEUROMARK System is a promising treatment because it has been shown to be safe and effective for treating chronic rhinitis, which is a condition related to nasal inflammation. This suggests it could be beneficial for movement disorders as well, as it targets nerve-related issues.
1112131415Eligibility Criteria
This trial is for adults over 18 who've had a runny or stuffy nose from non-seasonal allergies for at least 6 months. They must be fit for the NEUROMARK treatment under local anesthesia and willing to follow the study's procedures. People with severe nasal structure issues, recent nasal surgery, or those treated before for rhinitis aren't eligible.Inclusion Criteria
I have a runny nose and nasal congestion with a symptom score of at least 5 out of 12.
I am a suitable candidate for a NEUROMARK device treatment under local anesthesia.
I am 18 years old or older.
+2 more
Exclusion Criteria
I have a severe nasal blockage that could affect treatment access.
I had sinus or nasal surgery less than 6 months ago.
My runny nose and sneezing are caused by seasonal allergies.
+1 more
Participant Groups
The NEUROMARK RCT Study is testing a new system designed to treat chronic rhinitis symptoms against a sham (fake) procedure. Participants won't know which they receive in this controlled test where treatments are assigned randomly.
2Treatment groups
Active Control
Placebo Group
Group I: ActiveActive Control1 Intervention
Subjects 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. Sham control participants will be offered the option to receive active treatment after the 90-day follow-up provided they still meet all eligibility criteria.
NEUROMARK System is already approved in United States for the following indications:
🇺🇸 Approved in United States as NEUROMARK System for:
- Chronic rhinitis
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
East Alabama ENTOpelika, AL
Sensa HealthLos Angeles, CA
ExcelENTHomewood, AL
Breathe Clear InstituteTorrance, CA
More Trial Locations
Loading ...
Who Is Running the Clinical Trial?
Neurent MedicalLead Sponsor
References
Parkinson's disease: the non-motor issues. [2022]Non-motor symptoms (NMS) of Parkinson's disease remain the most under-appreciated and under-researched when taken as a whole. Data is emerging that it is the "totaL" burden of NMS that is the major determinant of quality of life not a single NMS such as depression for instance. Only recently validated tools such as the NMSQuest which empowers patients to declare NMS and the NMS scale, the SCOPA scales, and the modified version of the MDS-UPDRS have become available and validated for bedside clinical assessment of NMS. For the first time clinical trials have been incorporating non-motor measures as outcome measures and clinical recommendations for treatment of non-motor symptoms of PD are being published. This review aims to address some of these topical and "real life" aspects of modern day management of Parkinson's.
Limitations of the Unified Multiple System Atrophy Rating Scale as outcome measure for clinical trials and a roadmap for improvement. [2022]The unified multiple system atrophy (MSA) rating scale (UMSARS) was developed almost 20 years ago as a clinical rating scale to capture multiple aspects of the disease. With its widespread use, the shortcomings of the UMSARS as a clinical outcome assessment (COA) have become increasingly apparent. We here summarize the shortcomings of the scale, confirm some of its limitations with data from the Natural History Study of the Synucleinopathies (NHSS), and suggest a framework to develop and validate an improved COA to be used in future clinical trials of disease-modifying drugs in patients with MSA.
Effects of rotigotine transdermal patch in patients with Parkinson's disease presenting with non-motor symptoms - results of a double-blind, randomized, placebo-controlled trial. [2021]Non-motor symptoms (NMS) of Parkinson's disease (PD) have a major impact on health-related quality of life. This is the first randomized controlled trial to use the NMS Scale (NMSS) as a primary outcome to assess treatment effects on NMS in PD.
The Parkinson's Disease Comprehensive Response (PDCORE): a composite approach integrating three standard outcome measures. [2021]There is an increasing need for improved endpoints to assess clinical trial effects in Parkinson's disease. We propose the Parkinson's Disease Comprehensive Response as a novel weighted composite endpoint integrating changes measured in three established Parkinson's outcomes, including: OFF state Movement Disorder Society Unified Parkinson's Disease Rating Scale Motor Examination scores; Motor Experiences of Daily Living scores; and total good-quality ON time per day. The data source for the initial development of the composite described herein was a recent Phase II trial of glial cell line-derived neurotrophic factor. A wide range of clinically derived relative weights was assessed to normalize for differentially scoring base rates with each endpoint component. The Parkinson's disease comprehensive response, in contrast to examining practically defined OFF state Unified Parkinson's Disease Rating Scale Motor Examination scores alone, showed stability over 40 weeks in placebo patients, and all 432 analyses in this permutation exercise yielded significant differences in favour of glial cell line-derived neurotrophic factor. The findings were consistent with results obtained employing three different global statistical test methodologies and with patterns of intra-patient change. Based on our detailed analyses, we conclude it worth prospectively evaluating the clinical utility, validity and regulatory feasibility of using clinically supported final Parkinson's disease comprehensive response formulas (for both the Unified Parkinson's Disease Rating Scale-based and Movement Disorders Society-Unified Parkinson's Disease Rating Scale-based versions) in future disease-modifying Parkinson's trials. Whilst the data source employed in the initial development of this weighted composite score is from a recent Phase II trial of glial cell line-derived neurotrophic factor, we wish to stress that the results are not described to provide post hoc evidence of the efficacy of glial cell line-derived neurotrophic factor but rather are presented to further the debate of how current regulatory approved rating scales may be combined to address some of the recognized limitations of using individual scales in isolation.
Responsiveness of UMSARS and other clinical measures in a longitudinal structured care clinic for multiple system atrophy. [2023]As understanding of multiple system atrophy (MSA) pathophysiology improves, clinical trials of disease-modifying therapies are starting. Outcome measures responsive to disease progression will be critical, but the United MSA Rating Scale (UMSARS) has limitations. The MSA multidisciplinary clinic at the University of Texas Southwestern is a longitudinal clinic with structured assessments performed at fixed time intervals. The objective of this study was to evaluate the performance of clinical measures in assessing MSA progression over time.
Drug discovery and development: Biomarkers of neurotoxicity and neurodegeneration. [2023]Attrition in drug discovery and development remains a major challenge. Safety/toxicity is the most prevalent reason for failure with cardiovascular and CNS toxicities predominating. Non-invasive biomarkers of neurotoxicity would provide significant advantage by allowing earlier prediction of likely neurotoxicity in preclinical studies as well as facilitating clinical trials of new therapies for neurodegenerative conditions such as Parkinson's disease (PD) and multiple sclerosis (MS).
Society of Toxicologic Pathology Neuropathology Interest Group Article: Neuropathologic Findings in Nonhuman Primates Associated With Administration of Biomolecule-Based Test Articles. [2022]The increasing specificity of novel druggable targets coupled with the complexity of emerging therapeutic modalities for treating human diseases has created a growing need for nonhuman primates (NHPs) as models for translational drug discovery and nonclinical safety assessment. In particular, NHPs are critical for investigating potential unexpected/undesired on-target and off-target liabilities associated with administration of candidate biotherapeutics (nucleic acids, proteins, viral gene therapy vectors, etc.) to treat nervous system disorders. Nervous system findings unique to or overrepresented in NHPs administered biomolecule-based ("biologic") test articles include mononuclear cell infiltration in most neural tissues for all biomolecule classes as well as neuronal necrosis with glial cell proliferation in sensory ganglia for certain viral vectors. Such test article-related findings in NHPs often must be differentiated from procedural effects (e.g., local parenchymal or meningeal reactions associated with an injection site or implanted catheter to administer a test article directly into the central nervous system) or spontaneous background findings (e.g., neuronal autophagy in sensory ganglia).
Minimally Invasive Nasal Depot (MIND) technique for direct BDNF AntagoNAT delivery to the brain. [2022]The limitations of central nervous system (CNS) drug delivery conferred by the blood-brain barrier (BBB) have been a significant obstacle in the development of large molecule therapeutics for CNS disease. Though significantly safer than direct CNS administration via intrathecal (IT) or intracerebroventricular (ICV) injection, the topical intranasal delivery of CNS therapeutics has failed to become clinically useful due to a variety of practical and physiologic drawbacks leading to high dose variability and poor bioavailability. This study describes the minimally invasive nasal depot (MIND) technique, a novel method of direct trans-nasal CNS drug delivery which overcomes the dosing variability and efficiency challenges of traditional topical trans-nasal, trans-olfactory strategies by delivering the entire therapeutic dose directly to the olfactory submucosal space. We found that the implantation of a depot containing an AntagoNAT (AT) capable of de-repressing brain derived neurotrophic factor (BDNF) expression enabled CNS distribution of ATs with significant and sustained upregulation of BDNF with efficiencies approaching 40% of ICV delivery. As the MIND technique is derived from common outpatient rhinological procedures routinely performed in Ear, Nose and Throat (ENT) clinics, our findings support the significant translational potential of this novel minimally invasive strategy as a reliable therapeutic delivery approach for the treatment of CNS diseases.
Recommendation on test readiness criteria for new approach methods in toxicology: Exemplified for developmental neurotoxicity. [2020]Multiple non-animal-based test methods have never been formally validated. In order to use such new approach methods (NAMs) in a regulatory context, criteria to define their readiness are necessary. The field of developmental neurotoxicity (DNT) testing is used to exemplify the application of readiness criteria. The costs and number of untested chemicals are overwhelming for in vivo DNT testing. Thus, there is a need for inexpensive, high-throughput NAMs, to obtain initial information on potential hazards, and to allow prioritization for further testing. A background on the regulatory and scientific status of DNT testing is provided showing different types of test readiness levels, depending on the intended use of data from NAMs. Readiness criteria, compiled during a stakeholder workshop, uniting scientists from academia, industry and regulatory authorities are presented. An important step beyond the listing of criteria, was the suggestion for a preliminary scoring scheme. On this basis a (semi)-quantitative analysis process was assembled on test readiness of 17 NAMs with respect to various uses (e.g. prioritization/screening, risk assessment). The scoring results suggest that several assays are currently at high readiness levels. Therefore, suggestions are made on how DNT NAMs may be assembled into an integrated approach to testing and assessment (IATA). In parallel, the testing state in these assays was compiled for more than 1000 compounds. Finally, a vision is presented on how further NAM development may be guided by knowledge of signaling pathways necessary for brain development, DNT pathophysiology, and relevant adverse outcome pathways (AOP).
Incorporating new approach methodologies into regulatory nonclinical pharmaceutical safety assessment. [2023]New approach methodologies (NAMs) based on human biology enable the assessment of adverse biological effects of pharmaceuticals and other chemicals. Currently, however, it is unclear how NAMs should be used during drug development to improve human safety evaluation. A series of 5 workshops with 13 international experts (regulators, preclinical scientists, and NAMs developers) was conducted to identify feasible NAMs and to discuss how to exploit them in specific safety assessment contexts. Participants generated four “maps” of how NAMs can be exploited in the safety assessment of the liver, respiratory, cardiovascular, and central nervous systems. Each map shows relevant endpoints measured and tools used (e.g., cells, assays, platforms), and highlights gaps where further development and validation of NAMs remains necessary. Each map addresses the fundamental scientific requirements for the safety assessment of that organ system, providing users with guidance on the selection of appropriate NAMs. In addition to generating the maps, participants offered suggestions for encouraging greater NAM adoption within drug development and their inclusion in regulatory guidelines. A specific recommendation was that pharmaceutical companies should be more transparent about how they use NAMs in-house. As well as giving guidance for the four organ systems, the maps provide a template that could be used for additional organ safety testing contexts. Moreover, their conversion to an interactive format would enable users to drill down to the detail necessary to answer specific scientific and regulatory questions.
Clinical evaluation of a novel multipoint radiofrequency ablation device to treat chronic rhinitis. [2023]Safety and efficacy of the NEUROMARK® system for treating chronic rhinitis.
Olfaction in Primary Atrophic Rhinitis and Effect of Treatment. [2022]To assess olfactory and clinical morbidity in primary (idiopathic)-type atrophic rhinitis and its course following treatment.
The role of neurotrophins in the pathophysiology of allergic rhinitis. [2009]Allergic rhinitis is characterized by allergic airway inflammation and a hyperresponsiveness to nonspecific stimuli which is partly neuronally controlled. In this regard, neurotrophins are prime candidates as mediators of neuronal and immunological plasticity and they will be the focus of the current review.
Specific inhalation challenge with flour induced release of brain-derived neurotrophic factor in nasal fluid. [2016]Neurotrophins may play a role in the pathophysiology of allergic occupational rhinitis (OR). We sought to investigate whether an immediate allergic reaction that induces nasal inflammation is also able to induce changes in levels of brain-derived neurotrophic factor (BDNF) in nasal lavage (NAL) fluid from patients with allergic OR.
Effect of the TRPV1 antagonist SB-705498 on the nasal parasympathetic reflex response in the ovalbumin sensitized guinea pig. [2021]Nasal sensory nerves play an important role in symptoms associated with rhinitis triggered by environmental stimuli. Here, we propose that TRPV1 is pivotal in nasal sensory nerve activation and assess the potential of SB-705498 as an intranasal therapy for rhinitis.