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Rasagiline Reduces “Off Time” in Parkinson’s Patients
- Oct 31 2003
The novel monoamine oxidase type B inhibitor rasagiline reduces "off" time and improves motor function in Parkinson's disease patients with levodopa-related motor fluctuations, according to Phase III data released on October 20th at the 128th Annual Meeting of the American Neurological Association.
Dr. Matthew Stern, University of Pennsylvania, Philadelphia, Pennsylvania, United States, presented results in 472 patients with Parkinson's disease who were randomised to 26 weeks of treatment with rasagiline 1.0 or 0.5 mg per day or placebo.
Participants in the trial had idiopathic disease confirmed by at least two of the cardinal signs (resting tremor, bradykinesia, rigidity) and were experiencing levodopa-associated motor fluctuations for at least 2.5 hours daily in the "off" state. Subjects also had a modified Hoehn and Yahr stage of less than 5 in the "off" state and were receiving at least three daily doses of levodopa.
The primary pre-specified response variable was the change in total daily "off" time measured by home diaries.
Compared with placebo, the amount of daily "off" time in the rasagiline 1.0 mg/day group was reduced by 0.94 hours (P<0.001) and in the 0.5 mg/d group was reduced by 0.49 hours (P<0.02).
Significant improvement was also observed in the 7-point, physician-rated clinical global improvement scale, activities of daily living in the "off" state, and the minor subscale of the Unified Parkinson's Disease Rating Scale measured during the "on" state.
Individual adverse event rates were low. Significantly more patients on rasagiline experienced anorexia, ataxia, vomiting, and weight loss. Placebo patients were significantly more depressed. The rates of serious events and withdrawals from the trial were not significantly different in the three treatment groups.
"In light of the previously reported benefits in otherwise untreated patients with early Parkinson's disease, rasagiline represents a promising new treatment for Parkinson's disease," Dr. Stern said.
The study, known as PRESTO (Parkinson's Rasagiline: Efficacy and Safety in the Treatment of "Off" trial, was supported by Teva Pharmaceuticals Ltd.
Study title: A Controlled Trial of Rasagiline in Parkinson's Disease Patients With Levodopa-Related Motor Fluctuations
Source Date: Oct 31 2003