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    NINDS Efficacy and Exploratory Clinical Trials (UG3/UH3 - Clinical Trial Required)

    Supports investigator-initiated clinical trials for neurological disorders, from early exploratory studies to Phase 3 confirmatory and comparative effectiveness trials.

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    This grant was recently updated

    This grant has transitioned from forecasted to posted and is now accepting applications.

    Funder: National Institutes of Health

    Due Dates: November 9, 2026 (All application types) | February 10, 2027 (New) | March 10, 2027 (Renewal/resubmission/revision) | June 10, 2027 (New) | July 9, 2027 (Renewal/resubmission/revision) | October 8, 2027 (New) | November 8, 2027 (Renewal/resubmission/revision) | February 10, 2028 (New) | March 10, 2028 (Renewal/resubmission/revision) | June 9, 2028 (New) | July 10, 2028 (Renewal/resubmission/revision) | October 10, 2028 (New) | November 9, 2028 (Renewal/resubmission/revision) | February 9, 2029 (New) | March 9, 2029 (Renewal/resubmission/revision; final closing)

    Funding Amounts: Budgets are not capped and must reflect project needs; up to 7 years total; no cost sharing required.

    Summary: Supports investigator-initiated exploratory, confirmatory, and comparative effectiveness clinical trials of interventions for neurological disorders.

    Key Information: Clinical trials are required; applications involving foreign subawards or subcontracts will not be considered.


    Description

    The National Institute of Neurological Disorders and Stroke (NINDS) supports investigator-initiated clinical trials intended to prevent neurological disorders or improve their outcomes. Eligible interventions include small molecules, biologics, devices, surgical procedures, behavioral therapies, diet-based approaches, and rehabilitation strategies. Studies addressing neurological diseases and care across the lifespan are highly encouraged.

    The program supports early- and middle-phase exploratory trials, confirmatory or pivotal trials, and comparative effectiveness trials. Pragmatic trials with minimal changes to clinical practice and low per-participant costs are encouraged, as are rare-disease trials and innovative designs, including seamless Phase 2/3 trials. Awards use a milestone-driven UG3/UH3 cooperative agreement: a start-up and feasibility phase precedes full trial implementation, with substantial NINDS scientific and programmatic involvement.


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