The trials were conducted in North America by the Huntington Study Group (HSG) and in Europe in conjunction with the European HD Network (EHDN). The company expects to report trial results in mid-second quarter 2007.
The primary endpoint of the trials is a change in the Total Motor Score 4 (TMS-4) component of the Unified Huntington's Disease Rating Scale (UHDRS). In addition, secondary endpoints include cognition, behavioral and Total Functional Capacity outcomes.
Motor dysfunction is a prominent and progressively deteriorating feature of Huntington's disease (HD), an ultimately fatal genetic disease causing uncontrolled movements, loss of intellectual faculties, emotional disturbances, psychosis and dementia.
Currently, there are limited treatment options for HD patients and there is no approved treatment in the US. Earlier studies of Miraxion showed encouraging improvements in motor function in HD patients.
Patients in the both the trials may now switch to an open-label extension period where all patients will receive Miraxion and will continue to be assessed in accordance with the trial protocol.