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ZELAPAR® + levodopa/carbidopa active time study ZELAPAR® + levodopa/carbidopa active time study

EFFICACY

Add 2.2 hours MORE active time1-3

Significantly reduced OFF time as early as 1 week1,3

Daily OFF time before and after adding ZELAPAR® to levodopa/carbidopa
Reduction in average percentage of daily “OFF” time during waking hours was the primary efficacy endpoint. aP<.05 at weeks 1 and 2. bP<.001 at weeks 4, 10, and 12. cP<.01 at week 8.

Average daily OFF time before and after adding ZELAPAR to levodopa/carbidopa1-3

Daily OFF time before and after adding ZELAPAR® to levodopa/carbidopa
Patients receiving levodopa/carbidopa + placebo (n=46) had an average decrease in OFF time of 0.6 hours (7.0 hours at baseline; 6.4 hours at weeks 10-12).3

With MORE dyskinesia-free active time1-3

  • 1.8 hours MORE dyskinesia-free ON time with ZELAPAR (P =.006)2,3

After 12 weeks, patients receiving levodopa/carbidopa + ZELAPAR (n=94) had, on average, 10.8 hours of dyskinesia-free ON time, compared with 9.0 hours at baseline

Patients receiving levodopa/carbidopa + placebo (n=46) had, on average, 9.0 hours of dyskinesia-free ON time at week 12, compared with 8.6 hours at baseline

Dyskinesia-free “ON” time was a secondary efficacy endpoint.
Study Design1,3

In a multicenter, randomized, placebo-controlled trial (N=140), 94 patients were randomized to ZELAPAR and 46 to placebo. The patients enrolled had a mean duration of Parkinson's disease of 7 years and demonstrated an average of at least 3 hours of "OFF" time per day. Patients treated with ZELAPAR received a daily dose of 1.25 mg for the first 6 weeks and 2.5 mg for the last 6 weeks. All patients were treated with concomitant levodopa/carbidopa products and could additionally have been taking concomitant dopamine agonists, anticholinergics, amantadine, or any combination of these during the trial; catechol-O-methyltransferase (COMT) inhibitors were not allowed. Dose reductions of levodopa/carbidopa were allowed during this study only if dopaminergic side effects, including dyskinesia and hallucinations, emerged; no dose increases were allowed. Reduction in average percentage of daily “OFF” time during waking hours was the primary efficacy endpoint. “ON” time and dyskinesia-free “ON” time were secondary efficacy endpoints.