• The effectiveness of Zelapar® (selegiline HCl) as an adjunct to levodopa/carbidopa in the treatment of Parkinson’s disease was established in a multicenter randomized placebo-controlled trial (n=140; 94 received Zelapar 46 received placebo) of three months’ duration.
• Patients were randomized to receive a daily dose of Zelapar 1.25 mg for the first 6 weeks and a daily dose of 2.5 mg for the last 6 weeks. Patients were all treated with concomitant levodopa products and could additionally have been on concomitant dopamine agonists, anticholinergics, amantadine, or any combination of these during the trial. COMT (catechol–O–methyl–transferase) inhibitors were not allowed.
• Patients with idiopathic Parkinson’s disease receiving levodopa were enrolled if they demonstrated an average of at least 3 hours of OFF time per day on weekly diaries collected during a 2–week screening period. The patients enrolled had a mean duration of Parkinson’s disease of 7 years, with a range from 0.3 years to 22 years.
• During the 12 week study, patients were asked to record the amount of “OFF,” “ON,” “ON with dyskinesia,” or “sleep” time per day for two separate days during the week prior to each scheduled visit. The primary efficacy outcome was the reduction in average percentage daily OFF time during waking hours from baseline to the end of the trial (averaging results at Weeks 10 and 12). Both treatment groups had an average of 7 hours per day of OFF time at baseline.
• At the end of 12 weeks, Zelapar treated patients had an average of 2.2 hours per day less OFF time compared to baseline. Placebo–treated patients had 0.6 hours per day less OFF time compared to baseline. The observed reduction in OFF time between the two treatment groups compared to baseline was statistically significant (p<0.001).

For more information on Parkinson’s disease clinical trials, visit www.pdtrials.org and www.clinicaltrials.gov.