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START (Subarachnoid hemorrhage Translational Advanced Research pre-Trial) Network for Promising Novel Drug Testing

Award Number: R01NS144324
ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/01/2026
PERIOD OF PERFORMANCE END DATE: 06/30/2031

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START (Subarachnoid hemorrhage Translational Advanced Research pre-Trial) Network for Promising Novel Drug Testing - ABSTRACT Subarachnoid hemorrhage (SAH) is a particularly devastating event. The case-fatality rate remains 35-46% despite advances in surgical and medical care with many survivors being permanently disabled and suffering significant long-term cognitive deficits. The only current proven treatment for post-SAH cerebral infarction is prophylactic oral nimodipine, but even with nimodipine, up to 30% of patients will suffer cerebral infarction and brain injury. Every recent candidate treatment has failed in clinical trials. Clearly we need better treatment, however drugs that were promising in animal studies have thus far all been disappointing in human clinical trials. The disconnect between preclinical animal studies and human clinical trials is blamed on: scientific irreproducibility, drug administration at non-clinically relevant time points in animal models, flawed animal models, lack of generalizability of animal data to human disease, and positive publication bias. In this proposal, we will create Subarachnoid hemorrhage Translational Advanced Research pre-Trial (START) Network, a network of three sites to perform rigorous testing in a late-stage, multi-site, blinded, randomized trial in animals designed to closely resemble phase 3 randomized human clinical trials. The first two drugs to be tested by START will be tocilizumab, a monoclonal antibody to IL-6 receptor, and resveratrol, a sirtuin 1 (SIRT1) agonist. In mouse SAH, IL-6 inhibition is associated with 10% improvement in neurobehavioral outcome and 30% improvement in vasospasm, and resveratrol with 21% improvement in neurobehavioral outcome and 30% improvement in vasospasm. Tocilizumab is advantageous in that it is already FDA-approved for human use for other conditions and resveratrol is a dietary supplement not requiring FDA-approval. The objective of this proposal is for START to determine the suitability of tocilizumab and/or resveratrol as a novel drug for SAH prior to phase 3 human clinical trial. We will conduct a 3-site, blinded, randomized trial of tocilizumab or resveratrol versus placebo in animals with SAH to determine if tocilizumab and/or resveratrol improves neurological outcome at clinically relevant time points, and across animal ages, sex, and comorbidities. In addition, safety events and cerebral infarcts will be compared. The impact of this project will be to establish a network for the rigorous preclinical trial testing of novel drugs for SAH. The expected outcome will be to determine “go” or “no-go” for tocilizumab and/or resveratrol for SAH in phase 3 randomized human clinical trial. Future directions for START will be the study of additional drugs or interventions for SAH, taking advantage of the infrastructure established and refined with this project.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $611,097 )
2026	2026	UNIVERSITY OF FLORIDA	1523 UNION RD RM 207	GAINESVILLE	FL	32611	ALACHUA	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	1	7/1/2026	NEW	$611,097
														Subtotal = $611,097

Grand Total All Awards = $611,097

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START (Subarachnoid hemorrhage Translational Advanced Research pre-Trial) Network for Promising Novel Drug Testing

Award Number: R01NS144324

ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 07/01/2026

PERIOD OF PERFORMANCE END DATE: 06/30/2031

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