Abstract
Background: Rasagiline and pramipexole act to improve striatal dopaminergic transmission in PD via distinct and potentially synergistic mechanisms. We performed a placebo-controlled study to determine whether 2 doses of a novel slow-release, low-dose combination of rasagiline and pramipexole (P2B001) are effective and have a good safety profile in patients with early untreated PD. Methods: Previously untreated patients with early PD were randomized (1:1:1) to once-daily treatment with P2B001 (0.3 mg pramipexole/0.75 mg rasagiline), P2B001 (0.6 mg pramipexole/0.75 mg rasagiline) or placebo in a 12-week multicenter double-blind, placebo-controlled trial. The primary endpoint was the change from baseline to final visit in Total-UPDRS score versus placebo. Secondary measures included responder analyses of patients achieving ≥4 UPDRS point reduction, and changes in Parkinson Disease Quality of Life Scale–39 and UPDRS activities of daily living and motor scores. Results: A total of 149 participants were randomized and 136 (91.3%) completed the study. Adjusted mean change from baseline to final visit versus placebo in Total-UPDRS score was −4.67 ± 1.28 points for the P2B001 0.6/0.75 mg group (P =.0004) and −3.84 ± 1.25 points for the 0.3/0.75 mg group (P =.003). Significant benefits were also observed for both doses in the responder analysis (P =.0002 and P =.0001), Parkinson Disease Quality of Life Scale–39 scores (P =.05 and P =.01), and the UPDRS motor (P =.02 and P =.006) and activities of daily living (P =.005 and P =.0004) subscores. Adverse events of P2B001 were comparable to placebo apart from transient nausea and somnolence, which were more common with P2B001 treatment. Conclusions: P2B001 offers a promising treatment option for patients with early PD with good clinical efficacy and a low risk of adverse events.
Original language | English |
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Pages (from-to) | 783-789 |
Number of pages | 7 |
Journal | Movement Disorders |
Volume | 32 |
Issue number | 5 |
DOIs | |
State | Published - May 2017 |
Keywords
- P2B001
- Parkinson's disease
- Pramipexole
- Rasagiline