NCT01893190

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

Nimodipine Microparticles to Enhance Recovery While Reducing TOxicity After subarachNoid Hemorrhage: Phase I/IIa Multicenter, Controlled, Randomized, Open Label, Dose Escalation, Safety, Tolerability, and Pharmacokinectic Study Comparing EG-1962 and Nimodipine in Patients With Aneurysmal Subarachnoid Hemorrhage

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Edge Therapeutics Inc · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is a Phase 1/2a multicenter, controlled, open label, and randomized, study. Part 1 of the study is a single dose escalation period to determine the MTD of EG-1962. During this period, a maximum of 6 dose level cohorts with up to 12 patients per cohort will be enrolled. In each cohort, patients will be randomly assigned in a ratio of 3:1 to receive either intraventricular EG 1962 or enteral nimodipine, respectively. The first cohort will receive 100 mg EG 1962. Upon completion of the dose escalation period, a safe and tolerable dose will be selected for further study. Part 2 of the study is a treatment period to assess the safety and tolerability of the selected dose of EG-1962. The safety and tolerability of a single intraventricular dose of EG 1962 will be compared to enteral nimodipine (60 mg given every 4 hours orally or via nasogastric or gastrostomy tube) for 21 days.

Conditions

• Ruptured Cerebral Aneurysm
• Ruptured Berry Aneurysm

Interventions

Type	Name	Description
DRUG	Nimodipine	Based upon Investigator Judgement
DRUG	Nimodipine Microparticles	Based upon Investigator Judgement

Timeline

• Start date: 2013-09-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2013-07-08
• Last updated: 2018-02-05

Locations

23 sites across 4 countries: United States, Canada, Czechia, Finland