Rasagiline Effective as Monotherapy for Early Parkinson's Disease: Presented at ANA

By Paula Moyer

SAN DIEGO, CA -- October 3, 2005 -- The investigative agent rasagiline (Agilect) is effective as monotherapy for patients with early Parkinson's disease, researchers reported here September 27th at the 130th annual meeting of the American Neurological Association (ANA).

"Rasagiline efficacy emerged as early as 4 weeks after initiation of treatment and was maintained for at least 52 weeks," said principal investigator Ursula Lena Prisco, PhD, Associate Director of Medical Affairs, Eisai Inc., Teaneck, New Jersey, United States. She added that the drug showed a high degree of safety over the treatment period, with an incidence of adverse effects that was similar to placebo and that decreased over time.

Eisai is partnering with Teva Pharmaceuticals and Lundbeck to market Agilect in the United States when it is approved by the Food and Drug Administration (FDA) for the treatment of Parkinson's disease.

The investigators studied rasigiline, a selective monoamine oxidase B inhibitor (MAO-B inhibitor) in the Rasagiline (TVP-1012) in Early Monotherapy for Parkinson's Disease Outpatients (TEMPO) study.

In the 52-week, double-blind, delayed-start trial, the investigators wanted to see how rasagiline monotherapy at doses of 1 mg or 2 mg daily would compare to placebo in patients with early Parkinson's disease.

The 404 subjects underwent 26 weeks of a placebo-controlled phase; the second phase evaluated early-versus delayed-start rasagiline treatment for another 26 weeks.

The investigators detected improvement after 4 weeks of treatment, with more rasagiline-treated patients showing improvement of more than 20% over baseline in Uniform Parkinson's Disease Rating Scales (UPDRS) scores than did those on placebo.

At 4 weeks, 21.8% of subjects on 1 mg and 20.5% of those on 2 mg of the drug had at least 20% improvement in UPDRS, compared to 16.1% of those on placebo.

By 8 weeks of treatment, more than 20% improvement over baseline was observed in 27.3% of subjects on 1mg and in 26.8% of those on 2 mg, compared to 14% of placebo patients (P = .006)

At 26 weeks, those on 1 mg had an average of 4.20 lower score on the UPDRS than those on placebo, and in the 2 mg group had an average of 3.56 lower compared to placebo (P < .0001). In addition, 47% of those on either dose of rasagiline had an improvement in UPDRS, compared to 28.3% of those on placebo (P< .001).

At 52 weeks, the investigators observed significantly less progression of Parkinson's disease, expressed as change from baseline in total UPDRS scores, in those who were on either dose of rasagiline at the start of the study, compared to those who were switched from placebo at week 26 (P >/= .05). The differences in mean scores were 1.68 units lower for those on 1 mg and 1.86 lower for those on 2 mg, compared to those who were switched from placebo (P < .03).

The most common adverse events were infection, headache, dizziness, and accidental injury, and occurred at similar rates in all groups, including the placebo group. Among those in the 1 mg group, 79.5% had any type of adverse event in the first 26 weeks, compared to 84% of those in the 2 mg group, and 78.5% of those on placebo.

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