These new data are from an open label follow-up extension of patients originally enrolled in the TEMPO trial, a 12-month study conducted in 32 centers in the US and Canada. Approximately half of the patients who received Agilect (rasagiline tablets) in the original TEMPO trial, and were still in the study after two years, were adequately maintained without additional dopaminergic therapy.
In this long-term extension study of up to 6.5 years, the mean annual unified Parkinson disease rating scale (UPDRS) decline for patients treated with Agilect only was two to three units, compared with reported historical rates of eight to 11 units in placebo-treated patients.
“Parkinson’s disease is chronic, so demonstrating a positive effect over the course of six and a half years, in these patients, provides hope that Agilect may offer a new alternative for early-stage PD patients,” said Dr Mark Lew, of the University of Southern California and participating investigator in the follow-up study. “Maintaining function is key in a patient’s ability to perform activities that are important to them.”