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.
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