Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)
ID: 356553Type: 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/356553

Additional Information

http://grants.nih.gov/grants/guide/rfa-files/RFA-NS-25-024.html
Timeline
    Description

    The National Institutes of Health (NIH) is offering a funding opportunity for research targeting Amyotrophic Lateral Sclerosis (ALS) patients through expanded access (EA) protocols, specifically under the initiative titled "Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)." This initiative aims to solicit applications for scientific research projects that utilize investigational drugs for ALS patients who are not eligible for clinical trials, with a focus on intermediate patient populations to address significant treatment gaps in ALS care. NIH plans to allocate up to $35 million in fiscal year 2025 to fund 2-5 new awards, contingent upon the quality of applications received, with a submission deadline of January 25, 2025. Interested applicants can find more information and contact NIH Grants Information at grantsinfo@nih.gov for inquiries.

    Point(s) of Contact
    grantsinfo@nih.gov
    Files
    Title
    Posted
    RFA-NS-25-024-Full-Announcement.html
    RFA-NS-25-024.html
    The National Institutes of Health (NIH) is offering funding opportunities through the Department of Health and Human Services for research targeting Amyotrophic Lateral Sclerosis (ALS) patients through expanded access (EA) protocols. Specifically, they seek grant applications for scientific research projects involving investigational drugs for ALS patients not eligible for clinical trials. The funding initiative aims to support intermediate patient population studies, enabling a more extensive understanding of ALS and addressing significant treatment gaps. Key components include a requirement for an Investigational New Drug (IND) application to be submitted to the FDA concurrently with the grant application. The program encourages the use of common data elements (CDEs) for standardized research data collection and strongly emphasizes stakeholder engagement to ensure diverse patient representation. NIH plans to allocate up to $35 million in fiscal year 2025 to fund 2-5 new awards, contingent upon meritorious applications. Eligible applicants include higher education institutions, non-profits, and for-profit organizations. Applications are due by January 25, 2025, with a focus on innovative protocols that enhance clinical trial methodologies and patient safety. The ultimate goal is to facilitate the development of therapies for ALS, reflecting a pressing need for improved treatment options for this life-threatening condition.
    Similar Opportunities
    Clinical Trials Addressing Unmet Needs of Rare Neurodegenerative Diseases (R01) Clinical Trials Required
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is offering a funding opportunity for clinical trials aimed at addressing unmet needs in rare neurodegenerative diseases through the Notice of Funding Opportunity (NOFO) RFA-FD-25-001. This initiative, mandated by the ACT for ALS Act, seeks to support trials that evaluate the efficacy and safety of products for new indications or changes in labeling, with the goal of increasing the number of approved treatments for these conditions affecting fewer than 200,000 individuals in the U.S. Eligible applicants include various organizations such as higher education institutions and non-profits, with funding amounts capped at $650,000 for standard applications and up to $900,000 for innovative approaches. Interested parties should note that applications will be accepted starting August 23, 2024, with letters of intent and full applications due by October 22, 2024. For further inquiries, applicants can contact Terrin Brown at terrin.brown@fda.hhs.gov.
    Studies Addressing Rare Neurodegenerative Diseases including ALS
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is forecasting a funding opportunity for studies addressing rare neurodegenerative diseases, including Amyotrophic Lateral Sclerosis (ALS). This grant aims to support research that advances the development of medical products intended to prevent, diagnose, mitigate, treat, or cure ALS and other rare neurodegenerative diseases in both adults and children. The initiative is crucial for addressing significant knowledge gaps in the field and is expected to have a substantial impact on the development of interventions for these conditions. Interested applicants can reach out to Terrin Brown at terrin.brown@fda.hhs.gov or by phone at 240-402-7610 for further information. The FDA anticipates awarding approximately 10 grants in fiscal year 2025, with no cost-sharing or matching requirements.
    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" (PAR-25-327), aimed at supporting Investigational New Drug (IND)-enabling studies and preparations for First-in-Human (FIH) clinical trials. This initiative focuses on advancing innovative gene-based therapies, such as oligonucleotides and viral vector approaches, for ultra-rare disorders affecting fewer than 6,000 patients, with an emphasis on projects that demonstrate robust proof of concept data and readiness for clinical trials. Eligible applicants include a wide range of organizations, including higher education institutions and various nonprofit and for-profit entities, with applications requiring detailed project planning and compliance with Good Manufacturing Practices (GMP). The application period opens on January 9, 2025, with a close date of October 8, 2027, and interested parties can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries.
    Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity titled "Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 Clinical Trial Optional)." This initiative aims to support the clinical validation of strong candidate biomarkers for neurological and neuromuscular disorders, focusing on establishing their clinical sensitivity and specificity in accordance with FDA guidelines. The program is particularly significant as it seeks to enhance public health outcomes by facilitating the implementation of validated biomarkers in clinical settings, thereby addressing critical healthcare needs in these areas. Interested applicants should note that the application period opens on January 21, 2025, and closes on June 22, 2026. For further inquiries, applicants can contact NIH Grants Information at grantsinfo@nih.gov, and additional details can be found at the provided link: https://grants.nih.gov/grants/guide/pa-files/PAR-25-055.html.
    Engineering Next-Generation Human Nervous System Microphysiological Systems (R21 Clinical Trials Not Allowed)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) has announced a funding opportunity titled "Engineering Next-Generation Human Nervous System Microphysiological Systems (R21 Clinical Trials Not Allowed)," aimed at encouraging exploratory research to develop advanced microphysiological systems (MPS) that accurately replicate complex human nervous system architectures. This initiative seeks to facilitate studies on nervous system development, function, and aging, particularly in relation to neurological diseases. The R21 grant allows for a budget of up to $275,000 over two years, with applications opening on January 16, 2025, and a submission deadline of January 7, 2026. Interested applicants can find more information and guidelines at the NIH grants website or contact NIH Grants Information at grantsinfo@nih.gov for further inquiries.
    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.
    Early and Late Stage Clinical Trials for the Spectrum of Alzheimers Disease/Alzheimers Related Dementias and Age-Related Cognitive Decline (R01 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) has announced a funding opportunity for early and late-stage clinical trials focused on Alzheimer's Disease (AD) and related dementias, as well as age-related cognitive decline. This initiative aims to develop and implement both pharmacological and non-pharmacological interventions to address cognitive and neuropsychiatric changes associated with these conditions, while also encouraging innovative trial designs and methodologies. Given the significant public health crisis posed by AD, which currently affects over six million Americans, this funding opportunity is part of a broader strategy to enhance research and develop effective therapies across the disease spectrum. Applications are due by January 7, 2025, and interested parties can find more information and submit proposals through the NIH ASSIST online system or contact NIH Grants Information at grantsinfo@nih.gov.
    NINDS Exploratory Clinical Trials (UG3/UH3 Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH), through the National Institute of Neurological Disorders and Stroke (NINDS), is offering a funding opportunity for investigator-initiated exploratory clinical trials under the UG3/UH3 mechanism. This initiative aims to support Phase 1 and Phase 2 clinical trials that address critical questions related to neurological disorders, focusing on studies involving drugs, biologics, devices, and early interventions. The program emphasizes rigorous research design and encourages diverse and innovative research teams, with grants potentially spanning up to five years, beginning with a planning phase before transitioning to execution. Interested applicants can find more information and application details at the provided link, with a submission deadline of March 10, 2025, and no cost-sharing or matching requirement.
    NINDS Exploratory Clinical Trials (UG3/UH3 Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH), through the National Institute of Neurological Disorders and Stroke (NINDS), is offering a funding opportunity for investigator-initiated exploratory clinical trials under the UG3/UH3 mechanism. This initiative aims to support Phase 1 and Phase 2 clinical trials that align with NINDS's mission, focusing on innovative approaches to evaluate drugs, devices, and interventions for neurological disorders. The funding is structured as a cooperative agreement with a maximum support period of five years, where the UG3 phase lasts up to two years, followed by a potential transition to the UH3 phase for executing clinical trials. Interested applicants should note that the application process opens on January 10, 2025, with a submission deadline of March 11, 2025. For further inquiries, applicants can contact NIH Grants Information at grantsinfo@nih.gov.
    Alzheimer's Drug-Development Program (U01 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering the Alzheimer's Drug-Development Program (U01 Clinical Trial Optional) to support the preclinical and early-stage clinical development of innovative drug candidates aimed at preventing or treating Alzheimer's disease (AD). This funding opportunity focuses on activities such as medicinal chemistry, pharmacokinetics, formulation development, and initial Phase I clinical testing, addressing the urgent public health challenge posed by AD, which currently affects approximately 6.7 million individuals in the U.S. Eligible applicants include a diverse range of organizations, with a funding ceiling of $1.5 million per year, and the application process is set to begin in January 2025, with a closing date of November 5, 2027. For further inquiries, interested parties can contact NIH Grants Information at grantsinfo@nih.gov.