This Funding Opportunity Announcement (FOA) encourages Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that propose biomarker validation trials or exploratory clinical trials of drugs, biologics, surgical therapies or devices for neurological disorders which may contribute to the justification for and provide the data required to design a future trial to confirm efficacy (i.e., a Phase III clinical trial) in the treatment of neurologic disease. The program will utilize the cooperative agreement mechanism to enable milestone-drive projects. Applications for drugs or biologics should provide compelling scientific evidence that the investigational agent proposed for study will reach/act upon the designated target or that its mechanism of action is such that it will be of benefit in ameliorating a specific aspect of the disease. Diseases chosen for study should be based on the NINDS' strategic plan and clinical research interests (www.ninds.nih.gov/funding/areas/index.htm). Successful applicants will be given access to the Neurology Network of Excellence in Clinical Trials (NeuroNEXT) infrastructure, which will provide data management support and recruitment/retention support, as well as on-site implementation of the clinical protocol.