The July edition of JNS also carries an editorial focusing on the clazosentan study. Dr Neal Kassell, Professor and Co-chairman of the Department of Neurological Surgery at the University of Virginia comments: "It is encouraging to finally, after nearly one-half century of futile investigations, be able to introduce into clinical trials an agent that, based on experimental studies, has a real potential for preventing vasospasm and, based on preliminary clinical studies, appears to be without significant side effects (including hypotension), as well as exhibiting a suggestion of efficacy."
Following detailed discussions with regulatory authorities worldwide, the findings of this study have already led to the initiation of a comprehensive Phase IIb/III development programme for clazosentan. A multi-centre, international, double-blind, randomized, placebo-controlled, parallel group, dose-finding study CONSCIOUS-1 (Clazosentan to Overcome Neurological iSChemia and Infarct OccUrring after Subarachnoid hemorrhage) will analyse the efficacy of 3 dose levels of clazosentan in preventing the occurrence of cerebral vasospasm following SAH, assessed by angiography. As a secondary endpoint, the study will also assess the ability of clazosentan to reduce the occurrence of early morbidity/mortality as well as overall safety and tolerability of the drug.
CONSCIOUS-1 is expected to recruit 400 patients in approximately 70 centers in 13 countries worldwide. Study results are expected in the first half of 2006. These results will determine the need, size and duration of a Phase III study.
Two pre-clinical studies suggest impact of clazosentan on endothelin receptors A and B
This study follows the publication in the June edition of the JNS of two pre-clinical studies which characterised the inhibitory effect of clazosentan on endothelin A (ETA) receptor mediated contraction and endothelin B (ETB) rec
Contact: Alexa Forbes