The purpose of this Funding Opportunity Announcement (FOA) is to provide a vehicle for submitting grant applications for investigator-initiated, multi-site, randomized, controlled Phase III clinical trials to the National Institute of Neurological Disorders and Stroke (NINDS). The trials may address any research question related to the mission and goals of the NINDS. Information about the mission, strategic plan and research interests of the NINDS can be found at the NINDS website (http://www.ninds.nih.gov/).