Safety and Tolerability of GTX-104 Compared with Oral Nimodipine in Patients with ASAH

Phase 3 Active not recruiting 100 enrolled Grace Therapeutics Inc.

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to deliver nimodipine via IV directly into the bloodstream and to determine if this is as safe and tolerable as oral nimodipine capsules.

Timeline

Start: 2023-10-20
Primary completion: 2024-12
Completion: 2024-12

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

paper No statistical analysis of the end point is planned. PMID 39875683 ↗

Publications

Choi AH, Chou SY, Ducruet AF, Kimberly WT, Loch Macdonald R, Rabinstein AA. Description of STRIVE-ON Study Protocol: 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, Phase III Trial (STRIVE-ON). Neurocrit Care. 2025 Jun;42(3):1107-1117. doi: 10.1007/s12028-024-02207-8. Epub 2025 Jan 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nimodipine	Small molecule	0.15 mg	Intravenous
Subject	Nimodipine	Small molecule	4 mg	Intravenous
Subject	Nimodipine	Small molecule	60 mg	Intravenous