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A Randomized Trial of a LowDose Rasagiline and Pramipexole Combination (P2B001) in Early Parkinson’s Disease

C. Warren Olanow MD, Karl Kieburtz MD, Mika Leinonen MSc, Lawrence Elmer MD, Nir Giladi MD, Robert A. Hauser MD, Olga S. Klepiskaya MD, David L. Kreitzman MD, Mark F. Lew MD, David S. Russell MD, Shaul Kadosh MSc, Pninit Litman PhD, Hadas Friedman MSc, Nurit Linvah PhD

Published: 3 April 2017 Journal Movement Disorders
DOI: 10.1002/mds.26941

Funding agency: This study was funded by Pharma Two B Ltd.
Relevant conflicts of interests/financial disclosures: CWO and KK have ownership interests in Clintrex LLC which provides consulting services for Pharma Two B Ltd. Additional consulting services are on file. SK reports receiving consultancy fees from Pharma Two B Ltd. PL, HF, and NL are employed by Pharma Two B Ltd.

 

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 (0.3mg pramipexole/0.75mg rasagiline), P2B001 (0.6mg pramipexole/0.75mg 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 0.6/0.75mg group (P5.0004) and 23.8461.25 points for the 0.3/0.75mg group (P5.003). Significant benefits were also observed for both doses in the responder analysis (P5.0002 and P5.0001), Parkinson Disease Quality of Life Scale–39 scores (P5.05 and P5.01), and the UPDRS motor (P5.02 and P5.006) and activities of daily living (P5.005 and P5.0004) 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. V C 2017 International Parkinson and Movement Disorder Society

Keywords Rasagiline; Pramipexole; P2B001; Parkinson’s disease

 

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