December 18, 2002 — Patients with early Parkinson disease (PD) treated with the drug rasagaline were better able to perform functions of daily living, had better motor ability and better moods, according to an article in the December issue of The Archives of Neurology, a journal of the American Medical Association.
According to background information in the article, rasagaline is a selective irreversible inhibitor of monoamine oxidase type B (MAO-B), and is thought to increase the concentration of dopamine in brain areas involved in PD. In a previous 10-week trial in patients with early, untreated PD, rasagaline was well tolerated.
Andrew Siderowf, M.D., of the University of Pennsylvania in Philadelphia, and colleagues conducted a placebo-controlled clinical trial over six months to determine the efficacy, safety and tolerability of rasagaline in patients with early, untreated PD.
The researchers randomly assigned 404 patients with early PD and not on dopaminergic therapy (a traditional treatment for PD usually initiated when symptoms worsen) to take 1 milligram per day (mg/d) (n=134), 2 mg/d (n=132) or placebo (n=138) for 26 weeks. Participants were evaluated with the Unified Parkinson's Disease Rating scale (UPDRS), which measures a person's ability to perform basic daily tasks like dressing and walking as well as a person's emotional well being, before treatment and at 26 weeks (higher UPDRS scores indicate more impairment). UPDRS scores were similar between the three groups at the beginning of the study (24.7 for the 1 mg/d group, 25.9 for the 2 mg/d group, and 24.5 for the placebo group).
At the end of 26 weeks, the researchers found that the UPDRS scores for participants taking 1 mg/d of rasagaline were lower by an average of 4.20 units, and scores for participants taking 2 mg/d of rasagaline were down an average of 3.56 units. There were no differences in the frequency of adverse events among the different treatment groups.
"This randomized, placebo-controlled clinical trial demonstrated that rasagaline at dosages of 1 mg and 2 mg per day results in better overall UPDRS performance compared with placebo over a 26-week period in patients with early PD," write the authors. "There were no advantages in efficacy for 2 mg/d of rasagaline compared with the 1 mg/d dosage."