{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,21]],"date-time":"2026-05-21T12:39:00Z","timestamp":1779367140334,"version":"3.53.0"},"reference-count":21,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2017,4,3]],"date-time":"2017-04-03T00:00:00Z","timestamp":1491177600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"Pharma Two B Ltd"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Movement Disorders"],"published-print":{"date-parts":[[2017,5]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Rasagiline and pramipexole act to improve striatal dopaminergic transmission in PD via distinct and potentially synergistic mechanisms. We performed a placebo\u2010controlled study to determine whether 2 doses of a novel slow\u2010release, low\u2010dose combination of rasagiline and pramipexole (P2B001) are effective and have a good safety profile in patients with early untreated PD.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Previously untreated patients with early PD were randomized (1:1:1) to once\u2010daily treatment with P2B001 (0.3\u2009mg pramipexole\/0.75\u2009mg rasagiline), P2B001 (0.6\u2009mg pramipexole\/0.75\u2009mg rasagiline) or placebo in a 12\u2010week multicenter double\u2010blind, placebo\u2010controlled trial. The primary endpoint was the change from baseline to final visit in Total\u2010UPDRS score versus placebo. Secondary measures included responder analyses of patients achieving \u22654 UPDRS point reduction, and changes in Parkinson Disease Quality of Life Scale\u201339 and UPDRS activities of daily living and motor scores.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>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\u2010UPDRS score was \u22124.67\u2009\u00b1\u20091.28 points for the P2B001 0.6\/0.75\u2009mg group (<jats:italic>P<\/jats:italic>\u2009=\u2009.0004) and \u22123.84\u2009\u00b1\u20091.25 points for the 0.3\/0.75\u2009mg group (<jats:italic>P<\/jats:italic>\u2009=\u2009.003). Significant benefits were also observed for both doses in the responder analysis (<jats:italic>P<\/jats:italic>\u2009=\u2009.0002 and <jats:italic>P<\/jats:italic>\u2009=\u2009.0001), Parkinson Disease Quality of Life Scale\u201339 scores (<jats:italic>P<\/jats:italic>\u2009=\u2009.05 and <jats:italic>P<\/jats:italic>\u2009=\u2009.01), and the UPDRS motor (<jats:italic>P<\/jats:italic>\u2009=\u2009.02 and <jats:italic>P<\/jats:italic>\u2009=\u2009.006) and activities of daily living (<jats:italic>P<\/jats:italic>\u2009=\u2009.005 and <jats:italic>P<\/jats:italic>\u2009=\u2009.0004) subscores. Adverse events of P2B001 were comparable to placebo apart from transient nausea and somnolence, which were more common with P2B001 treatment.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>P2B001 offers a promising treatment option for patients with early PD with good clinical efficacy and a low risk of adverse events. \u00a9 2017 International Parkinson and Movement Disorder Society<\/jats:p><\/jats:sec>","DOI":"10.1002\/mds.26941","type":"journal-article","created":{"date-parts":[[2017,4,5]],"date-time":"2017-04-05T07:15:31Z","timestamp":1491376531000},"page":"783-789","source":"Crossref","is-referenced-by-count":34,"title":["A randomized trial of a low\u2010dose Rasagiline and Pramipexole combination (P2B001) in early Parkinson's disease"],"prefix":"10.1002","volume":"32","author":[{"given":"C. Warren","family":"Olanow","sequence":"first","affiliation":[{"name":"Clintrex LLC, Rye New York USA"},{"name":"Mount Sinai School of Medicine New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karl","family":"Kieburtz","sequence":"additional","affiliation":[{"name":"Clintrex LLC, Rye New York USA"},{"name":"University of Rochester School of Medicine Rochester New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mika","family":"Leinonen","sequence":"additional","affiliation":[{"name":"Clintrex LLC, Rye New York USA"},{"name":"4Pharma AB Stockholm Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lawrence","family":"Elmer","sequence":"additional","affiliation":[{"name":"Gardner\u2010McMaster Parkinson Center University of Toledo Toledo Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nir","family":"Giladi","sequence":"additional","affiliation":[{"name":"Parkinson's Disease and Movement Disorders Center National Parkinson Foundation (NPF) Center of Excellence, Neurological Institute, Tel\u2010Aviv Medical Center, Sackler School of Medicine, Sagol School of Neuroscience, Tel Aviv University Tel Aviv Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert A.","family":"Hauser","sequence":"additional","affiliation":[{"name":"University of South Florida Parkinson's Disease and Movement Disorders Center, NPF Center of Excellence Tampa Florida USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olga S.","family":"Klepiskaya","sequence":"additional","affiliation":[{"name":"University of Colorado School of Medicine Denver Colorado USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David L.","family":"Kreitzman","sequence":"additional","affiliation":[{"name":"Parkinson's Disease and Movement Disorder Center of Long Island Commack New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark F.","family":"Lew","sequence":"additional","affiliation":[{"name":"University of Southern California (USC)\/Keck School of Medicine Los Angeles California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David S.","family":"Russell","sequence":"additional","affiliation":[{"name":"Institute for Neurodegenerative Disorders New Haven Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shaul","family":"Kadosh","sequence":"additional","affiliation":[{"name":"StatExcellence Ltd Nesher Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pninit","family":"Litman","sequence":"additional","affiliation":[{"name":"Pharma Two B Ltd Rehovot Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hadas","family":"Friedman","sequence":"additional","affiliation":[{"name":"Pharma Two B Ltd Rehovot 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