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New Studies on Once-Daily Extended Release Pramipexole Presented at American Academy of Neurology Annual Meeting
Date:4/29/2009

mized, double-blind trial comparing pramipexole extended release and immediate release formulations versus placebo after 18 weeks and 33 weeks of treatment, in patients with early PD:

  • A total of 253 patients were included in the 18-week confirmatory analysis. In these patients, the adjusted mean change in the Unified Parkinson's Disease Rating Scale (UPDRS)* II+III score from baseline to week 18 was -5.1 points in the placebo group, -8.1 points in the pramipexole extended release group (p=0.0282 vs. placebo), and -8.4 points in pramipexole immediate release group (p=0.0153 vs. placebo).
  • A sub-group of 84 patients had completed 33 weeks of treatment at the interim analysis cut-off and were included in the descriptive analysis of maintenance of efficacy. The UPDRS II+III score was almost unchanged from week 18 to week 33 in both pramipexole groups, while a worsening was observed in placebo patients. In the pramipexole extended release group, the adjusted mean change from baseline in the UPDRS II+III score was -11.5 points at week 33 and -11.8 points at week 18, a difference of +0.3 point (or 2.5 percent). For the pramipexole immediate release group, both changes (week 33 and week 18) were -11.9 points, a difference of 0 percent. For the placebo group, the mean change was -2.7 points at week 33 versus -4.2 points at week 18, a worsening of +1.5 points (or 35.7 percent).

*The Unified Parkinson's Disease Rating Scale (UPDRS) is a comprehensive tool, which was developed to follow the longitudinal course of PD-related disability and impairment. The UPDRS II+III score was used as the primary efficacy endpoint in both trials. UPDRS Part II relates to activities of daily living and UPDRS Part III relates to motor symptoms. The UPDRS II+III score ranges from 0 (no disability) to 160 (worst disability).

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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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