NCT05399550

Study to Evaluate The Safety and Efficacy of Balovaptan in Participants With Acute Ischemic Stroke at a High Risk of Developing Malignant Brain Edema

A Phase II, Randomized, Double Blind, Placebo Controlled Multicenter Study to Evaluate The Safety and Efficacy of Balovaptan in Patients With Acute Ischemic Stroke at High Risk of Developing Malignant Cerebral Edema

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate the safety, efficacy, and pharmacokinetics of balovaptan compared with placebo in participants with acute ischemic stroke (AIS) at risk of developing Malignant Cerebral Edema (MCE)

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DRUG	Balovaptan	Intravenous Solution
DRUG	Placebo	Matching Intravenous Solution

Timeline

• Start date: 2022-06-22
• Primary completion: 2022-11-17
• Completion: 2022-11-17
• First posted: 2022-06-01
• Last updated: 2023-08-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study