NCT03585270

Clinical Research Study With Clazosentan to Evaluate Its Effects on Preventing Complications Due to the Narrowing of the Blood Vessels (Vasospasm) in the Brain, Caused by Bleeding Onto the Surface of the Brain

A Prospective, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Phase 3 Study to Assess the Efficacy and Safety of Clazosentan in Preventing Clinical Deterioration Due to Delayed Cerebral Ischemia (DCI), in Adult Subjects With Aneurysmal Subarachnoid Hemorrhage (aSAH)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 409 (actual)
• Sponsor: Idorsia Pharmaceuticals Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate if clazosentan (on top of normal routine medical care) can reduce the risk of developing complications related to cerebral vasospasm and permanent brain damage as compared to normal routine medical care alone.

Detailed description

When a blood vessel just outside the brain bursts and causes bleeding onto its surface, the space surrounding the brain (the subarachnoid space) fills with blood. This condition is called subarachnoid hemorrhage. The bleeding due to the rupture of a pouch-like structure or a bulge (called an aneurysm) that formed on one of the blood vessels is condition called aneurysmal subarachnoid hemorrhage (aSAH). In this study, clazosentan is being tested against normal routine medical care to determine if clazosentan can reduce the risk of developing complications related to vasospasm and permanent brain damage. Participation will last for approximately 6 months from the episode of bleeding. For subjects randomized in the high-risk prevention group, treatment will start within 96 hours following the time of the aneurysm rupture, and be administered where possible, for 14 days. For subjects randomized in the early treatment group, treatment must begin within 24 hours of the time of the angiogram documenting the cerebral vasospasm necessary for entry into the study. Treatment will be administered for a minimum of 6 days and a maximum of 14 days. Recruitment in the early treatment group has been discontinued. The end-of-study will be conducted as a telephone interview 6 months after the episode of bleeding.

Conditions

• Aneurysmal Subarachnoid Hemorrhage

Interventions

Type	Name	Description
DRUG	Clazosentan	Clazosentan will be administered as a continuous intravenous infusion at the dose of 15 mg/hour for up to 14 days.
DRUG	Placebo	Placebo will be administered at the same infusion rate as clazosentan for up to 14 days.

Timeline

• Start date: 2019-02-03
• Primary completion: 2022-06-13
• Completion: 2022-11-18
• First posted: 2018-07-12
• Last updated: 2024-01-10
• Results posted: 2024-01-10

Locations

80 sites across 15 countries: United States, Austria, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Hungary, Israel, Italy, Poland, Spain, Sweden

Regulatory

• FDA-regulated drug study