The National Institute of Neurological Disorders and Stroke (NINDS) is offering the Exploratory Clinical Trials grant. This funding opportunity encourages investigator-initiated clinical trials addressing neurological research questions aligned with NINDS’s mission. The grant supports early-phase studies, including Phase 1 and 2 trials for drugs and biologics, feasibility studies for devices, and preliminary research into surgical, behavioral, or rehabilitation therapies. All supported exploratory trials must generate data and justification essential for future, larger-scale efficacy trials, such as Phase 3 or Pivotal studies. Utilizing the UG3/UH3 mechanism, the UG3 phase focuses on planning and Phase 1 execution, while successful progression to the UH3 phase supports the execution of Phase 2 clinical trials, contingent upon achieving defined milestones.
Opportunity ID: 357066
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-25-054 |
| Funding Opportunity Title: | NINDS Exploratory Clinical Trials (UG3/UH3 Clinical Trial Required) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.853 — Extramural Research Programs in the Neurosciences and Neurological Disorders |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Nov 12, 2024 |
| Last Updated Date: | Nov 12, 2024 |
| Original Closing Date for Applications: | Mar 10, 2025 |
| Current Closing Date for Applications: | Mar 10, 2025 |
| Archive Date: | Apr 15, 2025 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Public and State controlled institutions of higher education Independent school districts Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education County governments Small businesses Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments For profit organizations other than small businesses State governments Special district governments |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | The purpose of this Funding Opportunity Announcement (FOA) is to encourage grant applications for investigator-initiated exploratory clinical trials to the National Institute of Neurological Disorders and Stroke (NINDS). The trials must address questions within the mission and research interests of the NINDS and may include Phase 1 and 2 studies of drugs and biologics, feasibility studies of devices, and early studies of surgical, behavioral or rehabilitation therapies. All exploratory trials must contribute to the justification for and provide some of the data required to inform a future trial to establish efficacy (such as a Phase 3, Phase 4 or Pivotal trial). This FOA uses the UG3/UH3 mechanism. Only projects that provide satisfactory progress in the UG3 phase may move to the UH3 phase, as outlined below. For a drug, biologic or device that has not completed a Phase 1/Early Feasibility trial: The UG3 mechanism will be used to plan and execute the Phase I trial(s). If Phase 1 trials are successful, the UG3 will also include the planning phase of a Phase 2 trial. The UH3 mechanism will then support the execution of the Phase 2 clinical trial. Transition to the UH3 will depend on successfully reaching agreed upon milestones. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-25-054.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH Grants Information
grantsinfo@nih.gov Email:grantsinfo@nih.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | NIH Grants Information grantsinfo@nih.gov Email: grantsinfo@nih.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-I | Use for due dates on or after January 25, 2025 | PKG00288683 | Jan 10, 2025 | Mar 10, 2025 | View |
Package 1
Mandatory forms
357066 RR_SF424_5_0-5.0.pdf
357066 PHS398_CoverPageSupplement_5_0-5.0.pdf
357066 RR_OtherProjectInfo_1_4-1.4.pdf
357066 PerformanceSite_4_0-4.0.pdf
357066 RR_KeyPersonExpanded_4_0-4.0.pdf
357066 RR_Budget10_3_0-3.0.pdf
357066 PHS398_ResearchPlan_5_0-5.0.pdf
357066 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
357066 RR_SubawardBudget10_30_3_0-3.0.pdf
357066 PHS_AssignmentRequestForm_4_0-4.0.pdf
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