Investigative Anti-Parkinson's Drug Rasagiline Has Similar Effects in North American and European Trials: Presented at ANA

By Ed Susman

CHICAGO, IL -- October 10, 2006 -- The investigative anti-Parkinson's disease drug, rasagiline, appears to have similar impact on patients in 2 pivotal trials -- one held in the United States and Canada and the other mainly in Europe, researchers reported here at the 131st Annual Meeting of the American Neurological Association (ANA).

"Rasagiline 1.0 mg once daily shows favorable and comparable efficacy in these two studies," said Steven Schwid, MD, associate professor of neurology, University of Rochester, New York, New York, in his poster presentation on October 8th.

He looked at data accrued from the 472-patient, 26-week Parkinson's Rasagiline: Efficacy and Safety in the Treatment of "Off" (PRESTO) trial conducted in North America and data from the 687-patient, 18-week Lasting effect in Adjunct therapy with Rasagiline Given Once daily (LARGO) trial conducted in Europe, Israel and Argentina.

The methodology of the trial and the results indicate that pooling the data will increase the studies' statistical power and further validate the robustness of the results, Dr. Schwid noted.

In reviewing data on patient withdrawals, Dr. Schwid found that 11% of patients on rasagiline and 12% of patients on placebo withdrew in the North American trial while 10% of patients withdrew from rasagiline and 15% from placebo in the European trial. In PRESTO, 6% of rasagiline patients and 5% of placebo patients withdrew due to serious adverse effects. In the LARGO trial, 3% of rasagiline patients and 6% of placebo patients withdrew due to adverse events.

Those results indicate similar tolerability of rasagiline was shown in both studies.

"Rasagiline produces consistent benefits between studies," Dr. Schwid said. "It is rare to have 2 such geographically distinct studies suited for direct comparison and, indeed, this is the first demonstration of its kind with the field of Parkinson's disease," he said.

In the PRESTO study, 65% of patients taking rasagiline in addition to their background medication showed a 1-hour greater improvement in Parkinson's disease symptoms compared with 45% of patients on placebo. In the LARGO study, 51% of patients showed 1-our or greater improvements compared with 32% of patients taking placebo.


[Presentation title: Once-Daily Rasagiline Produces Consistent Treatment Benefits in U.S. and European Studies of PD Patients. Abstract S-81]