FDA Approves Protocol for Phase III Essential Tremor Clinical Trial


Foundation-funded pilot studies in U.S. and Canada laid groundwork for new trial

The trial will be a double-blinded, and patients will randomly be assigned to either a treatment or control (sham treatment) group. The study’s follow-up period will be one year.InSightec Ltd. announced on February 19, 2013 that the U.S. food and Drug Administration has approved the protocol for its pivotal Phase III clinical trial for treatment of essential tremor using the company’s ExAblate Neuro system. Intended to provide the safety and efficacy data needed for FDA pre-marketing approval, the multi-center study is expected to begin in mid-2013 and will be led by University of Virginia neurosurgeon W. Jeffrey Elias, MD.

The pivotal trial will build on the safety and initial effectiveness results from 32 essential tremor patients treated in several Phase I trials, including studies funded by the Focused Ultrasound Foundation at the University of Virginia in the U.S. and Sunnybrook Health Sciences Centre in Canada.

“This is a very exciting development. The pilot research we funded has already helped gain CE marking in Europe and now it is providing the groundwork for the next stage in the FDA approval process,” said Foundation Chairman Neal Kassell, MD. “If the pivotal trial confirms the pilot study data, we’re hoping that focused ultrasound will be cleared to fill the treatment gap experienced by essential tremor patients who have failed drug therapy and are not candidates for surgery.”