NINDS Exploratory Clinical Trials (UG3/UH3 Clinical Trial Required)
ID: 339577Type: Posted
Overview

Buyer

National Institutes of Health (HHS-NIH11)

Eligible Applicants

Others

Funding Category

Health

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Original Source

https://grants.gov/search-results-detail/339577

Additional Information

http://grants.nih.gov/grants/guide/pa-files/PAR-22-142.html
Timeline
    Description

    The National Institutes of Health (NIH), through the National Institute of Neurological Disorders and Stroke (NINDS), has announced a funding opportunity for investigator-initiated exploratory clinical trials (UG3/UH3) aimed at addressing neurological disorders. This initiative seeks applications for Phase 1 and Phase 2 trials that may involve drugs, biologics, surgical, behavioral, or rehabilitation therapies, with a focus on generating data to support future efficacy trials. The funding is open to a diverse range of eligible applicants, including universities, nonprofits, and tribal organizations, emphasizing the importance of rigorous methodologies and scientific rationale in the proposals. Interested applicants should note that the application deadline is March 10, 2025, and can find further details and contact information at the provided NIH link: http://grants.nih.gov/grants/guide/pa-files/PAR-22-142.html.

    Point(s) of Contact
    OERWebmaster03@od.nih.gov
    Files
    Title
    Posted
    PAR-22-142.html
    The Department of Health and Human Services, through the National Institutes of Health (NIH) and specifically the National Institute of Neurological Disorders and Stroke (NINDS), has issued a Funding Opportunity Announcement (FOA) for investigator-initiated exploratory Phase 1 and Phase 2 clinical trials (UG3/UH3). This reissue of announcement PAR-21-236 aims to support trials addressing neurological disorders through various interventions including drugs, biologics, surgical, behavioral, and rehabilitation therapies. The funding seeks applications with strong scientific rationale and rigorous methodologies that ensure safety, efficacy, and transparency. Key details include the eligibility of diverse organizations (e.g., universities, nonprofits, government entities) and the importance of early phase trials for planning future Phase 2 trials. The review process emphasizes the proposal's significance, innovative approach, and demonstrated capacity of the research team. Applications must adhere to specific NIH-guided standards for reporting and recruitment diversity. Overall, the FOA underscores the NIH's commitment to advancing neuroscience research through well-designed clinical trials that will generate data crucial for developing new therapeutic interventions for neurological disorders.
    Similar Opportunities
    NINDS Efficacy Clinical Trials (UG3/UH3 Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity for investigator-initiated efficacy clinical trials through the NINDS Efficacy Clinical Trials (UG3/UH3 Clinical Trial Required) program. This initiative aims to support clinical studies that evaluate drugs, biologics, devices, and various interventions targeting neurological disorders, requiring a phased approach where UG3 planning must precede UH3 execution. The trials must be well-designed with robust scientific rationale and diverse participant inclusion, emphasizing collaboration with patient advocacy groups and national networks. Interested applicants can find more information and application guidelines at the provided NIH link, with a submission deadline of January 9, 2025, and no cost-sharing or matching requirements. For inquiries, contact the NIH OER Webmaster at grantsinfo@nih.gov.
    NINDS Exploratory Clinical Trials for Small Business (R41/R42 Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity titled "NINDS Exploratory Clinical Trials for Small Business (R41/R42 Clinical Trial Required)" aimed at supporting Small Business Concerns (SBCs) in conducting investigator-initiated exploratory clinical trials related to neurological disorders. This initiative encourages applications for Phase I and II studies focusing on drugs, biologics, devices, and therapies that align with the mission of the National Institute of Neurological Disorders and Stroke (NINDS), emphasizing the inclusion of a Plan for Enhancing Diverse Perspectives (PEDP) to foster innovation. The maximum funding amounts are $295,924 for Phase I and $1,972,828 for Phase II projects, with applications required to demonstrate readiness for eventual FDA regulatory approval. Interested applicants can begin submitting proposals on December 5, 2023, with the application deadline set for September 5, 2026; for further inquiries, contact NIH Grants Information at grantsinfo@nih.gov.
    NINDS Exploratory Clinical Trials for Small Business (R43/R44 Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity for small business concerns (SBCs) through the NINDS Exploratory Clinical Trials program (R43/R44), aimed at supporting investigator-initiated exploratory clinical trials related to neurological disorders. This program invites applications for studies that evaluate drugs, biologics, devices, or therapies, generating preliminary data to inform future clinical development, with a focus on enhancing diverse perspectives within research teams. Eligible U.S.-based SBCs can apply for funding caps of up to $295,924 for Phase I and $1,972,828 for Phase II, with applications due by September 5, 2026. For further inquiries, applicants can contact NIH Grants Information at grantsinfo@nih.gov or visit the additional information link at https://grants.nih.gov/grants/guide/pa-files/PAR-23-311.html.
    Prospective Observational Comparative Effectiveness Research in Clinical Neurosciences (UG3/UH3 Clinical Trial Not Allowed)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity for prospective observational comparative effectiveness research (CER) in clinical neurosciences, specifically through the National Institute of Neurological Disorders and Stroke (NINDS). This initiative aims to encourage grant applications that investigate preventive strategies, diagnostic approaches, and various interventions, including drugs, devices, and therapies, that align with NINDS's mission. The funding mechanism follows a UG3/UH3 cooperative agreement structure, starting with a 2-year planning phase (UG3) that may transition into a 5-year observational study phase (UH3) upon meeting specific milestones. Interested applicants, including a diverse range of organizations, must submit their applications by May 7, 2025, and can find more information at the provided NIH link or contact the NIH OER Webmaster at OERWebmaster03@od.nih.gov for inquiries.
    NIH SIREN Neurologic Clinical Trials (UG3/UH3 - Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity for the SIREN Neurologic Clinical Trials (UG3/UH3), aimed at developing multi-center clinical trials focused on neurological emergencies. This initiative encourages applications from a diverse range of entities, including universities, nonprofit organizations, and various community-serving institutions, to utilize the SIREN Network's infrastructure for efficient trial management, statistical support, and patient recruitment. The overarching goal is to enhance understanding and treatment of neurological emergencies through collaborative clinical research, ultimately improving patient outcomes and advancing healthcare practices. Interested applicants should note that the application deadline is March 6, 2026, and can find further details and guidelines at the provided NIH link or contact grantsinfo@nih.gov for inquiries.
    Clinical Trial Readiness for Functional Neurological Disorders (U01 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is inviting applications for a funding opportunity titled "Clinical Trial Readiness for Functional Neurological Disorders (U01 Clinical Trial Optional)," aimed at enhancing clinical trial methodologies for Functional Neurological Disorders (FNDs). This initiative seeks to address critical challenges in the diagnosis and management of FNDs by encouraging the validation of biomarkers and clinical outcome assessments (COAs) that are specifically tailored for clinical trials. Given the significant healthcare burden posed by FNDs, which often require interdisciplinary approaches for effective management, this funding opportunity emphasizes the need for robust clinical evidence to improve treatment strategies and patient outcomes. Interested applicants, including a diverse range of organizations such as higher education institutions and community-based organizations, must submit their proposals by November 5, 2024, with funding contingent on NIH appropriations. For further inquiries, applicants can contact the NIH OER Webmaster at OERWebmaster03@od.nih.gov.
    NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Clinical Trials and Clinical Research (R44 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering NINDS Renewal Awards of Small Business Innovation Research (SBIR) Phase II Grants (Phase IIB) to support clinical trials and clinical research projects focused on neurological disorders. This funding opportunity encourages small business concerns (SBCs) to seek additional funding for projects previously funded by NIH SBIR and STTR Phase II awards, with an emphasis on facilitating the transition of these projects to commercialization through partnerships with third-party investors. The initiative aims to address the "Valley of Death" funding gap in medical biotechnology, particularly for products related to the mission of the National Institute of Neurological Disorders and Stroke (NINDS). Interested applicants must submit a Commercialization Plan and a Plan for Enhancing Diverse Perspectives (PEDP), with the application opening on August 5, 2024, and a closing date of April 5, 2027. For further inquiries, applicants can contact NIH Grants Information at grantsinfo@nih.gov.
    Joint NINDS/NIMH Exploratory Neuroscience Research Grant (R21 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering the Joint NINDS/NIMH Exploratory Neuroscience Research Grant (R21 Clinical Trial Optional) to support innovative and exploratory research projects in neuroscience. This grant aims to facilitate early-stage studies that assess novel avenues of investigation, particularly those that may involve significant risk but hold the potential for breakthroughs in understanding neuroscience or developing new methodologies. Eligible applicants include a wide range of organizations such as educational institutions, nonprofits, and tribal governments, with funding available up to $200,000 over two years. Interested parties should submit their applications by January 7, 2025, and can find additional information and application guidelines at the NIH website or contact grantsinfo@nih.gov for assistance.
    Translational Efforts to Advance Gene-based Therapies for Ultra-Rare Neurological and Neuromuscular Disorders (U01 - Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity titled "Translational Efforts to Advance Gene-based Therapies for Ultra-Rare Neurological and Neuromuscular Disorders" (U01), aimed at supporting Investigational New Drug (IND)-enabling studies and clinical trial planning for innovative gene-based therapeutics targeting ultra-rare diseases affecting fewer than 6,000 individuals. The program seeks to advance promising therapeutic candidates through robust proof-of-concept data and facilitate the submission of IND applications to the FDA, thereby addressing significant unmet medical needs within the ultra-rare disease community. Eligible applicants include higher education institutions, nonprofits, and governmental agencies, with a project period not exceeding two years and application deadlines ranging from October 2023 to February 2025. For further inquiries, interested parties can contact the NIH OER Webmaster at OERWebmaster03@od.nih.gov, and additional details can be found at the provided NIH link.
    Innovation Grants to Nurture Initial Translational Efforts (IGNITE): Neurotherapeutic Agent Characterization and In vivo Efficacy Studies (R61/R33 Clinical Trial Not Allowed)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) has announced the Innovation Grants to Nurture Initial Translational Efforts (IGNITE) program, aimed at funding pharmacodynamic, pharmacokinetic, and in vivo efficacy studies for novel therapeutic agents targeting neurological and neuromuscular disorders. This funding opportunity encourages diverse organizations, including historically black colleges, tribal governments, and community-based organizations, to develop innovative therapeutic approaches that demonstrate significant improvements over existing treatments. With funding available up to $499,000 per year and a maximum of $750,000 over three years, applicants must adhere to rigorous scientific standards and collaborate with multidisciplinary teams. Interested parties should note that the application deadline is October 21, 2024, and can reach out to the NIH OER Webmaster at FBOWebmaster@OD.NIH.GOV for further inquiries.