The encouraging results of the Focused Ultrasound Foundation-funded essential tremor Phase I pilot clinical trial at the University of Virginia have led to planning for the next data-gathering step required for regulatory approval: a global, multi-site pivotal Phase III study to evaluate the safety and efficacy of transcranial MR-guided focused ultrasound in treating essential tremor. Device maker InSightec, Ltd., which is sponsoring the study, has obtained U.S. Food and Drug Administration approval for a double-arm protocol and expects as many as eight sites and 72 patients to participate.
Principal investigator is W. Jeffrey Elias, MD, who led the UVA pilot study and developed its protocol.
Expected to begin in mid-2013, the pivotal trial will use InSightec’s ExAblate Neuro system, which received CE-marking in December 2012 for the treatment of essential tremor, Parkinson’s disease and neuropathic pain. InSightec said it will use pivotal study data to seek FDA pre-marketing approval of the system. – Written by Ellen C., McKenna