Safety and Tolerability of GTX-104 (Nimodipine Injection for IV Infusion) Compared with Oral Nimodipine in Patients Hospitalized for Aneurysmal Subarachnoid Hemorrhage (aSAH): a Prospective Randomized Trial

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Safety and Tolerability of GTX-104 (Nimodipine Injection for IV Infusion) Compared with Oral Nimodipine in Patients Hospitalized for Aneurysmal Subarachnoid Hemorrhage (aSAH): a Prospective Randomized Trial

Brief description of study

This safety study is a Phase 3, prospective, open-label, randomized (1:1 ratio), parallel group study of GTX-104 (nimodipine injection for IV infusion) compared with oral nimodipine, in subjects hospitalized for aSAH. Oral nimodipine is approved by the Food and Drug Administration (FDA) for “improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in patients with subarachnoid hemorrhage (SAH) from ruptured intracranial berry aneurysms regardless of their post-ictus neurological condition (i.e., Hunt and Hess Grades I-V).” The purpose of this study is to evaluate the safety and tolerability of GTX-104 compared to oral nimodipine.

Clinical Study Identifier: s23-00939

ClinicalTrials.gov Identifier: NCT05995405

Principal Investigator: Aaron S Lord.

Other Investigators: David E. Kahn, Jennifer A. Frontera, Leah Dickstein, Ting Zhou.

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