NINDS Efficacy Clinical Trials (U01) | PAR 17 102

Opportunity Information: Apply for PAR 17 102

The NINDS Efficacy Clinical Trials (U01) funding opportunity (PAR-17-102) is a National Institutes of Health (NIH) program designed to support investigator-initiated clinical trials that test whether an intervention actually works under controlled clinical conditions. The central focus is efficacy, meaning applicants are expected to propose trials aimed at determining the benefit of a treatment or therapeutic strategy for neurological disorders or stroke-related conditions that fall squarely within the mission and research priorities of the National Institute of Neurological Disorders and Stroke (NINDS). In practical terms, NINDS is looking for well-justified, rigorously designed human studies that can answer clinically meaningful questions and move the evidence base forward for prevention, treatment, or recovery in neurological disease.

This announcement is broad in the types of interventions it will consider, which gives applicants flexibility as long as the proposed work fits NINDS interests. Eligible trials may evaluate drugs and small-molecule therapeutics, biologics (such as antibodies or other biological products), and medical devices. It also explicitly allows non-pharmacologic approaches, including surgical interventions, behavioral therapies, and rehabilitation strategies. That scope is important because many neurological conditions require multimodal approaches, and NINDS is signaling that it will support efficacy testing across the full range of therapeutic options, not only traditional medications.

The award mechanism is a U01 cooperative agreement, which differs from a standard research project grant because it typically involves substantial scientific or programmatic involvement by the funding institute during the life of the project. In other words, while the trial remains investigator-initiated and led, recipients should expect more active coordination with NINDS compared to a conventional grant. This structure is often used for complex clinical trials where consistent oversight, milestone tracking, or coordination with institute priorities is necessary to ensure the study is carried out in a way that meets regulatory, ethical, and scientific standards.

From an administrative standpoint, the opportunity is categorized as discretionary funding and falls under the NIH health research activity area, with CFDA number 93.853. The original closing date listed for this specific posting was November 29, 2017, and the creation date was January 6, 2017. The source data does not provide an award ceiling or the expected number of awards, which means applicants would typically need to consult the full FOA text and NIH guidance for budget expectations, project period norms, and any limits tied to trial phase, scope, or overall costs.

Eligibility is expansive and includes a wide range of organizations that commonly participate in clinical research. Eligible applicants include state, county, city or township, and special district governments; independent school districts; and public housing or Indian housing authorities. Higher education institutions are eligible across public/state-controlled and private categories. Tribal entities are included both as federally recognized tribal governments and tribal organizations other than federally recognized governments, and the opportunity also highlights specific categories such as Tribally Controlled Colleges and Universities (TCCUs). Nonprofit organizations are eligible whether or not they have 501(c)(3) status, and both for-profit organizations (other than small businesses) and small businesses may apply as well. The announcement further emphasizes inclusivity for a variety of institution types and communities, explicitly listing Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, and Historically Black Colleges and Universities (HBCUs), along with faith-based and community-based organizations. It also notes eligibility for U.S. territory or possession entities and non-U.S. (foreign) organizations, as well as regional organizations and certain non-federally recognized tribal governments.

Overall, this FOA is best understood as a pathway for research teams with a strong scientific rationale and a readiness to run a rigorous efficacy-focused clinical trial to obtain NIH support, with the expectation that the proposed study addresses high-priority neurological questions aligned with NINDS mission areas. For applicants, the key is demonstrating that the trial is clinically important, methodologically sound, feasible to execute, and clearly within the NINDS scope, as defined by the institute’s stated research interests and mission on the NINDS website.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NINDS Efficacy Clinical Trials (U01)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853.
• This funding opportunity was created on 2017-01-06.
• Applicants must submit their applications by 2017-11-29. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for PAR 17 102

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