A Phase 2 interventional study of Clazosentan in Aneurysmal Subarachnoid Hemorrhage, sponsored by Idorsia Pharmaceuticals Ltd.. Completed at 11 sites in 3 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-07-10.
Sponsored by Idorsia Pharmaceuticals Ltd. · Phase 2, Interventional, and Treatment
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.
509 studies on the registry are indexed under Subarachnoid Hemorrhage; 124 are open to participants now.
This study's enrollment of 25 is below the median of 52 across 263 interventional studies indexed under Subarachnoid Hemorrhage.
Browse Subarachnoid Hemorrhage studies →Idorsia Pharmaceuticals Ltd. is the lead sponsor of 102 studies on the registry; 5 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 9 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Diluted solution administered as a continuous intravenous infusion at a rate of 15 mg/h for up to a cumulative maximum of 10 days
Drug: Clazosentan
Concentrated solution for intravenous injection
Also known as: ACT-108475
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
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Idorsia Pharmaceuticals Ltd.