Safety and Tolerability Study of EG-1962 in Aneurysmal Subarachnoid Hemorrhage

Summary

Phase 1/2a Multicenter, Controlled, Randomized, Open Label, Dose Escalation, Safety, Tolerability, and Pharmacokinetic Study Comparing EG-1962 and Nimodipine in Patients with Aneurysmal Subarachnoid Hemorrhage

Timeline

Start

2013-09

Primary completion

2016-01

Completion

2016-01

Publications

• Macdonald RL, Hanggi D, Strange P, Steiger HJ, Mocco J, Miller M, Mayer SA, Hoh BL, Faleck HJ, Etminan N, Diringer MN, Carlson AP, Aldrich F; NEWTON Investigators. Nimodipine pharmacokinetics after intraventricular injection of sustained-release nimodipine for subarachnoid hemorrhage. J Neurosurg. 2019 Dec 6;134(1):95-101. doi: 10.3171/2019.9.JNS191366. Print 2021 Jan 1.
• Hanggi D, Etminan N, Aldrich F, Steiger HJ, Mayer SA, Diringer MN, Hoh BL, Mocco J, Faleck HJ, Macdonald RL; NEWTON Investigators. Randomized, Open-Label, Phase 1/2a Study to Determine the Maximum Tolerated Dose of Intraventricular Sustained Release Nimodipine for Subarachnoid Hemorrhage (NEWTON [Nimodipine Microparticles to Enhance Recovery While Reducing Toxicity After Subarachnoid Hemorrhage]). Stroke. 2017 Jan;48(1):145-151. doi: 10.1161/STROKEAHA.116.014250. Epub 2016 Dec 8.
• Hanggi D, Etminan N, Macdonald RL, Steiger HJ, Mayer SA, Aldrich F, Diringer MN, Hoh BL, Mocco J, Strange P, Faleck HJ, Miller M. NEWTON: Nimodipine Microparticles to Enhance Recovery While Reducing Toxicity After Subarachnoid Hemorrhage. Neurocrit Care. 2015 Oct;23(2):274-84. doi: 10.1007/s12028-015-0112-2.

Drugs

Indications