Funded Projects
Explore our currently funded projects. You may search with all three fields, then focus your results by applying any of the dropdown filters. After customizing your search, you may download results and even save your specific search for later.
Project # | Project Title | Research Focus Area | Research Program | Administering IC | Institution(s) | Investigator(s) Sort descending | Location(s) | Year Awarded |
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3U24NS113844-02S1
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EPPIC-NET DCC | Clinical Research in Pain Management | Early Phase Pain Investigation Clinical Network (EPPIC-Net) | NINDS | NEW YORK UNIVERSITY SCHOOL OF MEDICINE | PETKOVA, EVA (contact); TROXEL, ANDREA B | New York, NY | 2021 |
NOFO Title: Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for PA-20-222: Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed)
NOFO Number: NOT-NS-20-107 Summary: There is a clear public health imperative to improve the care and outcomes of people who experience severe acute and chronic pain. The Early Phase Pain Investigation Clinical Network (EPPIC-Net) is charged with conducting deep phenotyping and biomarker studies for specific pain conditions – and with conducting high-quality phase II clinical trials to test novel non-opioid pain treatments with academic and industry partners. This research will extend EPPIC-Net’s current portfolio to develop novel and efficient data-analytic methodologies for complex medical data, such as those that are expected to be generated by the clinical trials conducted by EPPIC-Net. |
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1U24NS113844-01
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EPPIC-NET DCC | Clinical Research in Pain Management | Early Phase Pain Investigation Clinical Network (EPPIC-Net) | NINDS | NEW YORK UNIVERSITY SCHOOL OF MEDICINE | PETKOVA, EVA (contact); TROXEL, ANDREA B | New York, NY | 2019 |
NOFO Title: HEAL Initiative: Early Phase Pain Investigation Clinical Network - Data Coordinating Center (U24 Clinical Trials Not Allowed)
NOFO Number: RFA-NS-19-024 Summary: The Data Coordinating Center (DCC) of the Early Phase Pain Investigation Clinical Network (EPPIC-Net) will be the data and biospecimen manager for pain research within the HEAL Partnership. As such, it will host, manage, standardize, curate, and provide a sharing platform for data and biospecimens for HEAL initiatives, such as the Acute to Chronic Pain Signatures initiative and the BACPAC, in addition to EPPIC-Net studies. The DCC will develop and maintain a databank for depositing data, will link these data with a repository for biological samples, and will create a platform for teams to work together to analyze and interpret data. Further, the DCC will provide leadership in the statistical design and analysis of EPPIC-Net studies and will deploy advanced systems and processes for data collection, management, quality assurance, and reporting. The DCC will create, sustain, and continually advance a robust organization for the rapid design, implementation, and performance of high-quality rigorous Phase II clinical trials to test promising therapeutics for pain. |
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2R44NS115460-02
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Drug Free Nerve Block Device for the Relief of Pain and Symptoms in Migraines and other Headaches | Cross-Cutting Research | Small Business Programs | NINDS | THERMAQUIL, INC. | POPIELARSKI, STEPHEN (contact); YUAN, HSIANGKUO | Philadelphia, PA | 2021 |
NOFO Title: HEAL INITIATIVE: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 - Clinical Trial Required)
NOFO Number: RFA-NS-20-010 Summary: Migraines and other headaches are often debilitating for patients, yet few treatment options providing sustained relief exist. All available therapies, including frequently prescribed opioids, have considerable side effects or limitations. Therefore, novel treatment approaches are needed to reduce or eliminate the need to use opiates and other systemic pharmaceuticals. Thermaquil Inc. has developed a new way of stopping migraine and other headache pain by noninvasively blocking pain signal transmission in the head, which in initial studies allowed patients to discontinue use of opioids and other addictive pain medications. Thermaquil will now be conducting a larger randomized controlled trial to demonstrate the safety and effectiveness of this novel approach. After a baseline period, patients will be randomly assigned to the active or control condition and receive a single treatment. The study will continue for 12 weeks with the active versus control arms, before all patients will be given active therapy for an additional 12 weeks. |
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1U19NS130608-01
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Human Nociceptor and Spinal Cord Molecular Signature Center | Preclinical and Translational Research in Pain Management | Discovery and Validation of Novel Targets for Safe and Effective Treatment of Pain | NINDS | UNIVERSITY OF TEXAS DALLAS | PRICE, THEODORE J (contact); CURATOLO, MICHELE ; DOUGHERTY, PATRICK M | Richardson, TX | 2022 |
NOFO Title: HEAL Initiative: Discovery and Functional Evaluation of Human Pain-associated Genes and Cells (U19 Clinical Trial Not Allowed)
NOFO Number: NS22-018 Summary: This project will identify molecular characteristics of human sensory neurons and non-neuronal cells from the human dorsal root ganglia. This structure located outside the spinal cord is integrally involved in communicating pain signals to and from the brain. The research will use molecular approaches to characterize tissues obtained from organ donors and in patients who experience chronic pain. The findings will also help generate a connectivity map, or “connectome,” of nerve cell connections between the dorsal root ganglia of the spinal cord and the brain. |
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3R01NS098826-02S1
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PROTEASE ACTIVATED RECEPTOR TYPE 2 TARGETING FOR MIGRAINE PAIN | Preclinical and Translational Research in Pain Management | NINDS | UNIVERSITY OF TEXAS DALLAS | PRICE, THEODORE J; BOITANO, SCOTT; DUSSOR, GREGORY O; VAGNER, JOSEF | RICHARDSON, TX | 2018 | |
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591 Summary: Migraine is the most common neurological disorder. Currently available treatments fail to effectively manage migraine in most patients. Development of new therapeutics has been slow due in large part to a poor understanding of the underlying pathology of migraine. Endogenous proteases, released in the meninges by resident mast cells, have been proposed as a potential driver of migraine pain via an action on protease activated receptor type 2 (PAR2). The central hypothesis is that PAR2 expression in nociceptors that project to the meninges plays a key role in the pathogenesis of migraine pain. The aims are to: 1) use the established PAR2 development pipeline to design new PAR2 antagonists with improved drug-like properties; 2) use pharmacological tools in a novel mouse migraine model to further understand the potential role of PAR2 in migraine; and 3) use mouse genetics to study the cell type–specific role of PAR2 in migraine pain. |
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1R61NS113316-01
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Discovery and analytical validation of Inflammatory bio-signatures of the human pain experience | Preclinical and Translational Research in Pain Management | Discovery and Validation of Biomarkers, Endpoints, and Signatures for Pain Conditions | NINDS | THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT HOUSTON | PROSSIN, ALAN RODNEY | Houston, TX | 2019 |
NOFO Title: Discovery of Biomarkers, Biomarker Signatures, and Endpoints for Pain (R61/R33 Clinical Trial Optional)
NOFO Number: RFA-NS-18-041 Summary: Postoperative pain is a major contributor to the current opioid epidemic. Novel objective measures capable of personalizing pain care will enhance medical precision in prevention and treatment of postoperative pain. This project seeks to discover and validate a novel biosignature of the human pain experience, based on underlying IL-1 family cytokine activity and associated brain endogenous opioid function, that is readily quantifiable and clinically translatable to prevention and treatment of postoperative pain states. Specific aims will assess whether the novel biosignature will predict 1) experimentally induced pain during an experimental nociceptive pain challenge; 2) postoperative pain states with accuracy >75%, accounting for a wide range of variance in the human pain experience; and 3) postoperative pain states in an expanded clinically enriched sample. |
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1U24NS113800-01
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University of Florida Early Phase Pain Investigation Clinical Center | Clinical Research in Pain Management | Early Phase Pain Investigation Clinical Network (EPPIC-Net) | NINDS | UNIVERSITY OF FLORIDA | PRZKORA, RENE (contact); TIGHE, PATRICK J | Gainesville, FL | 2019 |
NOFO Title: HEAL Initiative: Early Phase Pain Investigation Clinical Network - Specialized Clinical Centers (U24 Clinical Trials Not Allowed)
NOFO Number: RFA-NS-19-025 Summary: A major barrier to developing new pain treatments has been the absence of infrastructure to facilitate well-designed and carefully conducted clinical trials to test the efficacy of promising treatments. The UF Health Specialized Clinical Center Network will include UF Health as “hub” and statewide partners serving as spokes as part of the EPPIC Network. The University of Florida (UF) has the capability to reach more than 50% of the population of Florida, the third most populous state of the United States, and the capacity to successfully enroll patients with varying pain conditions into clinical trial protocols through its hub and spoke infrastructure as part of EPPIC-Net. |
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1UG3HD102038-01
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Effectiveness of an mHealth psychosocial intervention to prevent transition from acute to chronic postsurgical pain in adolescents | Clinical Research in Pain Management | Pain Management Effectiveness Research Network (ERN) | NICHD | SEATTLE CHILDREN'S HOSPITAL | RABBITTS, JENNIFER (contact); PALERMO, TONYA M | Seattle, WA | 2019 |
NOFO Title: HEAL Initiative: Pain Management Effectiveness Research Network: Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)
NOFO Number: RFA-NS-19-021 Summary: The study team developed an mHealth pain self-management intervention for the perioperative period (SurgeryPal) to target psychosocial risk factors and teach pain self-management skills. The goal of this proposal is to establish the effectiveness of the SurgeryPal psychosocial intervention to improve clinically meaningful outcomes in adolescents undergoing major musculoskeletal surgery, and to identify the optimal timing of intervention delivery. The study team will plan for the efficient implementation of a multisite randomized clinical trial at 25 centers in 500 youth ages 12–18 years undergoing spinal fusion surgery and their parents. Participants will be randomized to receive SurgeryPal or attention control condition during the preoperative and postoperative phases. Self-reported pain severity and interference and secondary outcomes will be assessed at baseline, 3-, and 6-months. If effective, this scalable, low cost intervention will allow broad implementation to prevent chronic postsurgical pain in youth. |
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1R61AT012279-01
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Quantifying and Treating Myofascial Dysfunction in Post Stroke Shoulder Pain | Clinical Research in Pain Management | Discovery and Validation of Biomarkers, Endpoints, and Signatures for Pain Conditions | NCCIH | JOHNS HOPKINS UNIVERSITY | RAGHAVAN, PREETI | Baltimore, MD | 2022 |
NOFO Title: HEAL Initiative: Developing Quantitative Imaging and Other Relevant Biomarkers of Myofascial Tissues for Clinical Pain Management
NOFO Number: RFA-AT-22-003 Summary: Shoulder pain occurs in many patients who are recovering from a stroke. In addition to impairments in the ability to move, persistent shoulder pain contributes to depression, and often reduces quality of life. Although the cause of post-stroke shoulder pain is complex and not completely understood, it is thought to arise in part to damage of muscles and surrounding connective tissues (myofascial tissues) in the shoulder. This project will use advanced medical imaging techniques to create biomarkers of that can reliably identify myofascial tissues. The research will then test the ability of these biomarkers to monitor, and ultimately predict treatment responses in patients with post-stroke shoulder pain in the context of a randomized controlled clinical trial. |
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1R21AT012304-01
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Erythrocyte Autophagy Proteins as Potential Non-Opioid Novel Targets for Pain in Sickle Cell Disease | Preclinical and Translational Research in Pain Management | Discovery and Validation of Novel Targets for Safe and Effective Treatment of Pain | NCCIH | UNIVERSITY OF ILLINOIS, CHICAGO | RAMASAMY, JAGADEESH | Chicago, IL | 2022 |
NOFO Title: Emergency Awards: HEAL Initiative-Early-Stage Discovery of New Pain and Opioid Use Disorder Targets Within the Understudied Druggable Proteome (R21 Clinical Trial Not Allowed)
NOFO Number: TR22-011 Summary: Sickle cell disease is an inherited blood disorder affecting about 100,000 Americans and over 20 million people worldwide. It is caused by a mutation in the gene for beta-globin that results in the characteristic sickled shape of red blood cells, life-long severe pain, and shortened lifespan. Painful episodes that require hospitalization and, in many cases, opioid treatment, are a hallmark of sickle cell disease. The source of these painful episodes remains unclear, and it is also unknown why pain severity varies so much among affected individuals. This project will identify novel, non-opioid targets to reduce sickle cell-related pain and search for biomarkers to help clinicians predict which individuals are at risk for increased pain, thereby improving health outcomes for people with sickle cell disease. |
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1R43NS120335-01
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Closed-Loop Micromagnetic Neuromodulation as a Non-Opioid Treatment for Neuropathic Pain | Cross-Cutting Research | Small Business Programs | NINDS | QUANTUM NANOSTIM | REILLY, THOMAS | Treasure Island, FL | 2021 |
NOFO Title: HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 – Clinical Trial Not Allowed)
NOFO Number: RFA-NS-20-011 Summary: Spinal cord stimulation (SCS) has been shown to provide effective relief for most people with chronic pain and eliminated the need for opioid therapy in more than half of those treated. However, traditional SCS approaches have encountered problems when glial cells coat the stimulation electrodes that distance the device from targeted neurons. This project will develop a novel hybrid Closed Loop Omnidirectional Neuromodulation with Electromagnetic fields (CLONE) system that is combined with magnetic-based stimulation to overcome glial coating of SCS electrodes, better target neurons in dorsal spine tissue, which may lead to better treatment of chronic neuropathic neck and low back pain. |
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1U19NS130617-01
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Harvard PRECISION Human Pain Center | Preclinical and Translational Research in Pain Management | Discovery and Validation of Novel Targets for Safe and Effective Treatment of Pain | NINDS | BRIGHAM AND WOMEN'S HOSPITAL | RENTHAL, WILLIAM RUSSELL (contact); WOOLF, CLIFFORD J | Boston, MA | 2022 |
NOFO Title: HEAL Initiative: Discovery and Functional Evaluation of Human Pain-associated Genes and Cells (U19 Clinical Trial Not Allowed)
NOFO Number: NS22-018 Summary: This project will use state-of-the-art technologies to analyze individual cells to characterize how human pain receptors communicate pain between the human dorsal root ganglia and the brain – including how the signals vary across diverse populations. This research will generate useful, high-quality human data about pain for further analysis and re-use by other scientific teams, toward identifying and prioritizing novel therapeutic targets for pain. |
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1R43NS120617-01A1
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Chemokine-receptor profiling for painful diabetic neuropathy in biological samples from human clinical trials | Cross-Cutting Research | Small Business Programs | NINDS | PLUMERIA THERAPEUTICS, INC. | RICHARDSON, THOMAS P (contact); WANG, YIPING | Plainsboro, NJ | 2021 |
NOFO Title: HEAL INITIATIVE: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 - Clinical Trial Not Allowed)
NOFO Number: RFA-NS-20-011 Summary: Chronic pain is a major healthcare burden. However, the types and underlying mechanisms of pain vary greatly, as do patient responses to currently available pain medications. Inflammation in the nervous system (neuroinflammation) is involved in several types of pain, and targeting key molecules involved in neuroinflammation is therefore a promising treatment approach. The chemokine receptor system, a complex network of more than 20 different receptors and more than 80 molecules that bind to these receptors, has a central role in neuroinflammation. Researchers do not yet fully understand the functioning of this network and how specific receptors vary in different chronic pain conditions. Therefore, this project aims to further characterize the expression of one specific receptor, using samples collected from participants in clinical trials evaluating a compound that interferes with the receptor’s function. This information should allow researchers to classify pain patients and identify those most likely to benefit from a treatment with compounds targeting the receptor. |
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1U18EB030607-01
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Non-invasive Nonpharmaceutical Treatment for Neck Pain: Development of Cervical Spine-specific MR-guided Focused Ultrasound System | Preclinical and Translational Research in Pain Management | Translating Discoveries into Effective Devices to Treat Pain | NINDS | UNIVERSITY OF UTAH | RIEKE, VIOLA | Salt Lake City, UT | 2020 |
NOFO Title: HEAL Initiative: Translational Development of Devices to Treat Pain (U18 Clinical Trial Not Allowed)
NOFO Number: RFA-EB-18-003 Summary: Neck pain is the fourth leading cause of disability and also a significant cause of cervicogenic headaches. Many of the currently available neck pain treatments are invasive with associated risks and complications, particularly because of the complex anatomy. Magnetic resonance guided focused ultrasound, a novel, completely noninvasive technique, can precisely target spinal facet joints to help ameliorate neck pain, potentially transforming the current practices. The goal of this study is to develop a cervical spine-specific device and demonstrate its safety and efficacy on targeting cervical sensory fibers and the third occipital nerve. The results of these studies will provide an understanding on how to best use this technology for chronic neck pain as well as a basis for translation into human use. |
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1UH2AR076736-01
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Focused Ultrasound Neuromodulation of Dorsal Root Ganglion for Noninvasive Mitigation of Low Back Pain | Clinical Research in Pain Management | Back Pain Consortium Research Program | NIAMS | UNIVERSITY OF UTAH | RIEKE, VIOLA (contact); SHAH, LUBDHA | Salt Lake City, UT | 2019 |
NOFO Title: HEAL Initiative: Back Pain Consortium (BACPAC) Research Program Technology Research Sites (UH2/UH3 Clinical Trial Optional)
NOFO Number: RFA-AR-19-028 Summary: This project's goal is to develop a completely noninvasive, precise, and durable treatment option for low back pain (LBP). Focused ultrasound (FUS) is a lower-risk, completely noninvasive modality that enables the delivery of spatially confined acoustic energy to a small tissue region (dorsal root ganglion [DRG]) under magnetic resonance (MR) imaging guidance to treat axial low back pain by neuromodulation. The central goal of this study is to demonstrate neuromodulation of the DRG with FUS to decrease nerve conduction; this treatment can be used to attenuate pain sensation. This exploratory study will demonstrate FUS neuromodulation of the DRG in pigs as assessed by somatosensory evoked potential and perform unique behavioral assessments indicative of supraspinal pain sensation, with the ultimate goal of translating this technology to patients with LBP. FUS could potentially replace current invasive or systemically detrimental treatment modalities. |
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3U01DE027441-02S1
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DE-IMPLEMENTING OPIOID USE AND IMPLEMENTING OPTIMAL PAIN MANAGEMENT FOLLOWING DENTAL EXTRACTIONS | Clinical Research in Pain Management | NIDCR | HealthPartners Institute | RINDAL, D. BRAD | MINNEAPOLIS, MN | 2018 | |
NOFO Title: Implementation Science Research to Improve Dental, Oral and Craniofacial Health (U01)
NOFO Number: RFA-DE-18-001 Summary: The primary objective of this project is to de-implement the use of opioid analgesics for the management of postoperative pain following dental extractions and to implement effective alternative pain management. We propose a cluster-randomized trial designin which dental practitioners are randomly assigned to one of three conditions: 1) standard practice as a control condition; 2) a clinical decision support (CDS) tool that will extract patient history and interface with the state prescription drug monitoring program to provide personalized recommendations for analgesic prescribing and offer language for discussing non-opioid pain management; 3) an enhanced version of the CDS (CDS-E) that will also include information regarding optimal, evidence-based non-opioid pain management delivered to the patient both before and following the dental extraction visit. We will examine opioid and non-opioid prescribing data from the electronic health record across study arms as well as other provider- and patient-focused outcomes using mixed methods. |
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2R44DA045410-02
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Peripherally-Restricted Long-Acting Somatostatin Receptor 4 (LA-SSTR4) Agonists for Pain | Cross-Cutting Research | Small Business Programs | NIDA | PEPTIDE LOGIC, LLC | RIVIERE, PIERRE | San Diego, CA | 2019 |
NOFO Title: PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
NOFO Number: PA-18-574 Summary: The proposed SBIR Phase II program seeks to select a first-in-class, peripherally-restricted, and long-acting somatostatin receptor 4 (LA-SSTR4) agonist clinical candidate for development as a novel non-addictive analgesic able to replace opioids for the treatment of moderate-to-severe chronic pain. The program is based on strong scientific evidence showing that activation of peripheral SSTR4 produces broad spectrum analgesic activity and pursues a unique therapeutic strategy. Unlike opioids, SSTR4 agonists do not induce constipation, respiratory depression, dependence, addiction, or abuse. Finally, unlike SSTR2 and SSTR5, SSTR4 expression in the pituitary and pancreas is very low, supporting that selective SSTR4 agonists are unlikely to perturb peripheral endocrine functions. The preceding SBIR Phase I program has already established the feasibility of conjugating a short-acting, potent, and selective peptide SSTR4 agonist to the antibody carrier. The resulting LA-SSTR4 agonist lead series has high agonist potency and selectivity for SSTR4 and has demonstrated antinociceptive activity in an animal pain model. The proposed SBIR Phase II program seeks to: optimize the existing lead series and select a clinical candidate for development, validate and prioritize the indication(s) for clinical development using disease-relevant mouse pain models, and characterize the pharmacokinetics and safety/toxicology profile of the clinical candidate in rat and non-human primates to help design subsequent investigational new drug (IND)-enabling studies. |
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1OT2NS122680-01
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A Randomized, Double-blind, Placebo-controlled, Parallel, 20-week, Phase 2b Study of Topical Pirenzepine (WST-057) or Placebo in Type 2 Diabetes Mellitus Patients with Painful Diabetic Peripheral Neuropathy | Clinical Research in Pain Management | Early Phase Pain Investigation Clinical Network (EPPIC-Net) | NINDS | ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI | ROBINSON-PAPP, JESSICA | New York, NY | 2021 |
NOFO Title: HEAL Initiative: EPPIC-Net Pain Research - Application for Clinical Trial and Related Activities (OT2)
NOFO Number: OTA-20-008 Summary: People with diabetes are at risk for painful diabetic peripheral neuropathy. This pain may be experienced as burning, aching, hypersensitivity to touch, or simply as pain, and there are no currently FDA-approved medications that reduce its symptoms. This phase 2 clinical trial, through the EPPIC-NET program, will test a potential new treatment for painful diabetic peripheral neuropathy. The treatment, WST-057 (topical pirenzepine 4%), is a molecule that was developed in the 1980s and marketed throughout Europe and Asia in an oral form to treat gastric ulcers. Studies show that this type of molecule can increase the density of certain nerve fibers, which has been linked with improve patient-reported outcome measures for painful diabetic peripheral neuropathy. |
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1U24NS113849-01
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The Icahn School of Medicine at Mount Sinai (ISMMS) EPPIC-Net Specialized Clinical Center | Clinical Research in Pain Management | Early Phase Pain Investigation Clinical Network (EPPIC-Net) | NINDS | ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI | ROBINSON-PAPP, JESSICA | New York, NY | 2019 |
NOFO Title: HEAL Initiative: Early Phase Pain Investigation Clinical Network - Specialized Clinical Centers (U24 Clinical Trials Not Allowed)
NOFO Number: RFA-NS-19-025 Summary: The Icahn School of Medicine at Mount Sinai (ISMMS) will support the mission of the Early Phase Pain Investigation Clinical Network (EPPIC-Net), through the ISMMS Department of Neurology as the core of a hub and spokes structure. The study contains four specific aims: (1) to streamline and optimize rapid implementation of EPPIC-Net studies, exceeding the required minimum of 100 subjects recruited per year to EPPIC-Net studies; (2) to ensure access to patient populations with a wide range of pain disorders, including CLBP, using a hub and spokes model to ensure effective recruitment; (3) to provide the highest-quality protocol implementation, deep clinical phenotyping of pain disorders, and accurate and complete data collection; and (4) to work collaboratively with the EPPIC-Net Coordinating Centers and investigators from the NIH HEAL Partnership to assist with development/design of clinical trials. The study team will also increase training opportunities through EPPIC-Net within ISMMS and the larger pain research community, training junior investigators to become future pain clinical trials leaders and increase and disseminate knowledge about pain research throughout the network. |
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3U24NS113849-01S1
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The Icahn School of Medicine at Mount Sinai (ISMMS) EPPIC-Net Specialized Clinical Center | Clinical Research in Pain Management | Early Phase Pain Investigation Clinical Network (EPPIC-Net) | NINDS | ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI | ROBINSON-PAPP, JESSICA | New York, NY | 2020 |
NOFO Title: Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for Administrative Supplements to Promote Training in Clinical Research on Pain (Admin Supp ? Clinical Trial Not Allowed)
NOFO Number: NOT-NS-20-044 Summary: Exacerbation of health disparities has emerged during the COVID 19 pandemic and highlighted the recognition that minority underrepresentation in clinical research may contribute to racial disparities in health outcomes. In clinical trials related to pain, disparities in trial patient inclusion are documented by white patients often being overrepresented. Mitigating these disparities is an area in which an early-career pain investigator training and contributions may have lasting benefits. The pandemic also drove rapid expansion of telehealth for pain management without knowledge of how social and demographic factors affect utilization patterns of this care delivery model. This supplement supports research to examine the extent to which disparities exist in access to and outcomes of telehealth in socially marginalized pain patients. Findings will be applied to enrich the diversity in clinical trial populations for phase 2 safety trials performed in the HEAL EPPIC Network. |
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1OT2NS122680-01
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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of 80 mg o.d. of NRD135S.El Versus Placebo in Adult and Elderly Subjects with Painful Diabetic Peripheral Neuropathy (SERENDIPITY-I) | Clinical Research in Pain Management | Early Phase Pain Investigation Clinical Network (EPPIC-Net) | NINDS | ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI | ROBINSON-PAPP, JESSICA | New York, NY | 2021 |
NOFO Title: HEAL Initiative: EPPIC-Net Pain Research Asset Application (OT2)
NOFO Number: OTA-20-008 Summary: People with diabetes are at risk for painful diabetic peripheral neuropathy. This pain may be experienced as burning, aching, hypersensitivity to touch, or simply as pain, and there are no currently FDA-approved medications that reduce its symptoms. This phase 2 clinical trial, through the EPPIC-NET program, will test a potential new treatment for painful diabetic peripheral neuropathy. The molecule, NRD135S.E1, is a lab-made version of a natural substance traditionally used to brew tea to treat a variety of indications, including pain, in a village in Siberia. In clinical studies, NRD135S.E1 was well tolerated by patients and showed clinically relevant pain relief. Testing within EPPIC-Net will use a master protocol, an innovative study design in which multiple treatments can be tested at the same time with fewer research participants. |
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1R01HD110922-01
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CMG2 as a Target for Safe and Effective Treatment of Endometriosis-Associated Pain | Preclinical and Translational Research in Pain Management | Discovery and Validation of Novel Targets for Safe and Effective Treatment of Pain | NICHD | BOSTON CHILDREN'S HOSPITAL | ROGERS, MICHAEL SEAN | Boston, MA | 2022 |
NOFO Title: HEAL Initiative: Discovery and Validation of Novel Targets for Safe and Effective Pain Treatment (R01 Clinical Trial Not Allowed)
NOFO Number: NS22-034 Summary: Endometriosis is an often-painful disorder in which uterine tissue grows outside the uterus. Treatment of endometriosis-associated pain involves use of opioids in many women. This project aims to study a culprit gene thought to be involved with the disorder (capillary morphogenesis gene or CMG2) as a target for new, nonopioid pain medications. The research will also clarify how CMG2 s affects endometriosis-associated pain to test the effects of new medications for endometriosis pain. |
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3UH3NS116218-02S1
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Novel mGlu5 Negative Allosteric Modulators as First-in-Class Non-Addictive Analgesic Therapeutic | Preclinical and Translational Research in Pain Management | Development and Optimization of Non-Addictive Therapies to Treat Pain | NINDS | Vanderbilt University | ROOK, JERRI MICHELLE | Nashville, TN | 2022 |
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements. Parent Grant: HEAL Initiative: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional)
NOFO Number: Supplement: PA-20-272; Parent NOFO: NS-21-010 Summary: Negative allosteric modulators (NAMs) of the metabotropic glutamate (mGlu) receptor, mGlu5, have shown promise for treatment of multiple pain conditions without the serious adverse effects and safety concerns associated with opioids. This project will develop and test a novel series of highly selective mGlu5 NAMs that are structurally unrelated to earlier failed compounds and do not form toxic byproducts as with previous mGlu5 NAMs. A lead candidate is now being characterized in several studies to assess readiness for testing in Phase I clinical studies. |
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1UG3NS116218-01
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Novel mGlu5 negative allosteric modulators as first-in-class non-addictive analgesic therapeutics | Preclinical and Translational Research in Pain Management | Development and Optimization of Non-Addictive Therapies to Treat Pain | NINDS | VANDERBILT UNIVERSITY | ROOK, JERRI MICHELLE; CONN, P JEFFREY; GEREAU, ROBERT W; LINDSLEY, CRAIG | Nashville, TN | 2019 |
NOFO Title: Optimization of Non-addictive Therapies [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Not Allowed)
NOFO Number: RFA-NS-19-010 Summary: An extensive literature provides compelling evidence that selective antagonists or negative allosteric modulators (NAMs) of the metabotropic glutamate (mGlu) receptor, mGlu5, have exciting potential as a novel approach for treatment of multiple pain conditions that could provide sustained antinociceptive activity without the serious adverse effects and abuse liability associated with opioids. Researchers have developed a novel series of highly selective mGlu5 NAMs that are structurally unrelated to previous compounds, have properties for further development, and avoid the formation of toxic metabolites that were associated with previous mGlu5 NAMs. Based on existing preclinical models, as well as clinical trial data showing efficacy of an mGlu5 NAM in migraine patients, researchers anticipate that their compounds will have broad-spectrum analgesic activity in patients with a variety of chronic pain conditions. |
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1U19NS126038-01
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Site-directed RNA editing of Nav1.7 as a novel analgesic | Preclinical and Translational Research in Pain Management | Development and Optimization of Non-Addictive Therapies to Treat Pain | NINDS | MARINE BIOLOGICAL LABORATORY, WOODS HOLE | ROSENTHAL, JOSHUA J C (contact); DIB-HAJJ, SULAYMAN D; DUSSOR, GREGORY O; EISENBERG, ELI | New Haven, CT | 2021 |
NOFO Title: HEAL Initiative: Team Research for Initial Translational Efforts in Non-addictive Analgesic Therapeutics Development (U19 Clinical Trial Not Allowed)
NOFO Number: RFA-NS-21-015 Summary: Opioids are widely used pain treatments, despite their relative ineffectiveness for chronic pain and their high potential for misuse and addiction. There is thus an urgent need for alternative, non-addictive pain treatments. Genetic and functional studies of human pain disorders and animal models of pain have validated Nav1.7, a voltage-gated sodium channel as an attractive target for new pain treatments. Currently available blockers of these channels can sometimes provide symptomatic relief for patients but have worrisome side effects affecting the brain and heart. This study aims to develop and validate an innovative site-directed RNA editing strategy that will offer the ability to create new versions of molecules to block Nav1.7, toward establishing a novel, non-addictive approach to treat chronic pain. |