The purpose of this study is to evaluate the safety and potential therapeutic benefit of use of clazosentan in reversing cerebral vasospasm (a narrowing of blood vessels in the brain due to the presence of blood in the space around the brain) in patients who have suffered a condition known as aneurysmal subarachnoid hemorrhage caused by bleeding onto the surface of the brain from a ruptured brain aneurysm
Aneurysmal subarachnoid hemorrhage (aSAH) is characterized by bleeding onto the brain surface due to a rupture of a pouch or bulge in a brain vessel (called an aneurysm). It is a rare but serious condition with a high risk of death. Even patients who have had successful repair of the aneurysm remain at risk for developing cerebral vasospasm, which can result in harmful conditions related to the lack of oxygen to parts of the brain and death. Cerebral vasospasm usually occurs within the first couple of weeks after aSAH, and it is difficult to treat. Currently there is no safe, efficacious and widely available treatment. Previous animal studies have shown that a new drug under investigation, clazosentan, was able to reverse cerebral vasospasm in animal models of SAH. A first trial conducted in a small number of patients showed some benefit of clazosentan in reversing established cerebral vasospasm after aSAH. Clazosentan has already been evaluated in the prevention of cerebral vasospasm in several large clinical trials in aSAH. This current study aims to evaluate if clazosentan is effective and safe in the treatment of cerebral vasospasm after aSAH.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Concentrated solution for intravenous injection
Site 2002
Helsinki, Finland
Site 1002
Bron, France
Site 1006
Clermont-Ferrand, France
Site 1004
Marseille, France
Successful reversal of global cerebral vasospasm 3 hours post-study drug initiation
Successful reversal is defined as an improvement in at least one level of severity on the "global vasospasm assessment" (i.e., from severe to moderate, mild, or none, or from moderate to mild or none), evaluated on Digital subtraction angiogram (DSA)
Time frame: 3 hours post-study drug initiation
Successful reversal of global cerebral vasospasm 24 hours post-study drug initiation
Time frame: 24 hours post-study drug initiation
Maximum change from baseline in angiographic cerebral circulation time (CCT)
CCT will be determined in the left and right anterior circulation, and the posterior circulation, on the digital subtraction angiogram (DSA) at each scheduled time point.
Time frame: At baseline, 3 hours and 24 hours post-study drug initiation
Number of subjects with adverse events
An adverse event is defined as any unfavorable and unintended sign, including an abnormal laboratory finding, symptom or disease, that occurs during the course of the study, whether or not considered related to the study drug
Time frame: Up to 30 days after study drug discontinuation
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Site 1005
Montpellier, France
Site 1001
Paris, France
Site 3005
Aarau, Switzerland
Site 3001
Basel, Switzerland
Site 3003
Bern, Switzerland
Site 3004
Geneva, Switzerland
...and 1 more locations