NINDS Clinical Trial Networks (Other Transactions)

NINDS NeuroNEXT Network — OTA Clinical Trials

Supports exploratory neurological clinical research through collaborative exploratory transactions.

The NINDS NeuroNEXT Network funds exploratory clinical trials and biomarker studies for neurological diseases through a two-stage Other Transaction Authority (OTA) process. Stage 1, governed by OTA-24-013, is the preliminary application in which investigators describe the proposed trial or study concept; only applications that pass Stage 1 review may proceed to Stage 2 under OTA-24-014, which requires submission of a full protocol application. All NeuroNEXT awards use the OT2 mechanism, which is an Other Transaction instrument rather than a standard NIH grant or cooperative agreement, giving the network flexibility in contracting and milestone structures not available under traditional grant mechanisms.

The NeuroNEXT network is a NINDS-established infrastructure of academic clinical trial sites designed to execute early-phase and exploratory studies efficiently. Eligible applicants include universities, research institutions, for-profit companies, and nonprofits based in the United States. The scientific scope covers neurological diseases broadly, including rare and ultra-rare conditions; a parallel track within the network — the URGenT program (OTA-24-011/012) — specifically addresses gene-based and gene-targeted therapies for ultra-rare neurological diseases. The designated NINDS program contact for NeuroNEXT is Dr. Lumy Sawaki-Adams at lumy.sawaki-adams@nih.gov, and prospective applicants are expected to contact her before preparing a Stage 1 submission.

Because NeuroNEXT operates as a network infrastructure, applicants do not simply propose standalone trials — they propose studies that will be executed within the existing NeuroNEXT site network, using standardized operating procedures and shared data infrastructure. Budget structures, site selection, and protocol review follow network-specific processes that differ from standard NIH grant applications. The two-stage gate means that investment in a full protocol is contingent on Stage 1 scientific endorsement, reducing wasted effort for concepts that do not fit network priorities.