NINDS Exploratory Clinical Trials (UG3/UH3 Clinical Trial Required)

The National Institute for Neurological Disorders and Stroke (NINDS) is encouraging applications for their Exploratory Clinical Trials grant, requiring a UG3/UH3 Clinical Trial. This grant is aimed at supporting investigator-initiated exploratory clinical trials. The trials should align with the objectives and interests of NINDS, including studies such as Phase 1 and 2 trials involving drugs and biologics, feasibility studies of devices, and early studies of surgical, behavioral, or rehabilitation therapies.

The purpose of these exploratory trials is to contribute to the data needed for justifying future trials focused on establishing efficacy, such as Phase 3, Phase 4, or Pivotal trials. The UG3/UH3 mechanism is employed in this grant. Satisfactory progress in the UG3 phase is necessary to progress to the UH3 phase.

Specifically, for a drug, biologic, or device that hasn't completed a Phase 1/Early Feasibility trial, the UG3 phase will be used to plan and carry out the Phase 1 trial(s). If Phase 1 trials are successful, the UG3 phase will also include planning for a Phase 2 trial. The execution of the Phase 2 clinical trial will then be supported by the UH3 mechanism, contingent upon the successful achievement of agreed milestones.

If a drug, biologic, or device has successfully completed the Phase 1/Early Feasibility trial(s), this grant is not applicable. Instead, a Companion Funding Opportunity Announcement (FOA XXX) should be used. Similarly, this grant does not apply to genetic studies; FOA XXX should be utilized for such trials.