A randomized trial of a low-dose Rasagiline and Pramipexole combination (P2B001) in early Parkinson's disease

Mov Disord. 2017 May;32(5):783-789. doi: 10.1002/mds.26941. Epub 2017 Apr 3.


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. © 2017 International Parkinson and Movement Disorder Society.

Keywords: P2B001; Parkinson's disease; Pramipexole; Rasagiline.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Antiparkinson Agents / therapeutic use*
  • Benzothiazoles / therapeutic use*
  • Delayed-Action Preparations
  • Double-Blind Method
  • Drug Combinations
  • Female
  • Humans
  • Indans / therapeutic use*
  • Israel
  • Male
  • Middle Aged
  • Neuroprotective Agents / therapeutic use*
  • Parkinson Disease / drug therapy*
  • Pramipexole
  • Severity of Illness Index
  • Triethylenemelamine
  • United States


  • Antiparkinson Agents
  • Benzothiazoles
  • Delayed-Action Preparations
  • Drug Combinations
  • Indans
  • Neuroprotective Agents
  • rasagiline
  • Pramipexole
  • Triethylenemelamine