Planned Pivotal Trial
In the phase III trial of DBS in early Parkinson’s disease, investigators plan to enroll 280 patients at 18 centers. Eligible patients will have received medication for Parkinson’s disease for at least one year but less than four years and have no history of motor fluctuations. All participants will undergo DBS surgery and be randomized to have their stimulator kept off and continue on standard medical therapy, or to have their stimulator turned on in addition to receiving medical therapy. Researchers will follow the participants for two years.
The primary end point for the trial will be a composite measure that assesses whether, at 24 months, a patient worsened or not. Worsening will be defined as a three-point increase in the Unified Parkinson’s Disease Rating Scale (UPDRS) III on-treatment motor score, combined with a one-point increase in the UPDRS IV complications of therapy score, Dr. Charles said.
—Jake Remaly
