Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)
Agency: National Institutes of Health
Assistance Listings: 93.853 -- Extramural Research Programs in the Neurosciences and Neurological Disorders
Description
The National Institute of Neurological Disorders and Stroke (NINDS) is interested in supporting the conduct of scientific research utilizing data from intermediate-size patient population expanded access protocols for ALS ("intermediate expanded access protocol for ALS", see Expanded Access Categories for Drugs (Including Biologics)). Eligible intermediate expanded access protocols for ALS should: 1) provide access to an investigational drug or biological product for people with ALS, and 2) generate data to support research on the prevention, diagnosis, mitigation, treatment, or cure of ALS. The scientific research goal(s) informed by these data could include the investigational drug's or biological product's effect on biomarkers related to the pathophysiology of ALS or target engagement, the collection of safety or outcome information, such as survival or other significant medical events (e.g., hospitalization or need for ventilatory support), or patient experience data that are not specifically tied to assessing efficacy.
Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop responsive projects.
Eligibility
Eligible applicants
Nonprofit
- Nonprofits non-higher education without 501(c)(3)
- Nonprofits non-higher education with 501(c)(3)
- Other Native American tribal organizations
Education
- Private institutions of higher education
- Public and state institutions of higher education
Government
- State governments
- Federally recognized Native American tribal governments
- County governments
- City or township governments
- Special district governments
Miscellaneous
- Other
Business
- For-profit organizations other than small businesses
- Small businesses
Additional information
Grantor contact information
Description
NINDSALSMailbox@mail.nih.gov
Documents
No documents are currently available.
Link to additional information
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Forecasted
Estimated Post Date:
March 1, 2027
Estimated Application Due Date:
May 25, 2027
Estimated Due Date Description:
Not available
Estimated Award Date:
April 1, 2028
Estimated Project Start Date:
April 1, 2028
Fiscal Year:
2028
Award
$--
Program Funding
--
Expected awards
$--
Award Minimum
$--
Award Maximum
Funding opportunity number:
RFA-NS-28-009
Cost sharing or matching requirement:
Funding instrument type:
Cooperative agreement
Opportunity Category:
Discretionary
Opportunity Category Explanation:
Category of Funding Activity:
Health
Category Explanation:
History
Version:
1
Forecast posted date:
September 23, 2026
Archive date:
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