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We assessed the efficacy and safety of S90049 in aborting OFF episodes responding to subcutaneous apomorphine in PD patients with motor fluctuations. This was a single\u2010dose double\u2010blind double\u2010placebo 3 \u00d7 3 cross\u2010over study. Optimal tested doses were determined during a previous open\u2010label titration phase (S90049 median dose: 60 mg, apomorphine: 5 mg). Primary endpoint was the maximal change versus baseline in UPDRS motor score (\u0394UPDRS III) assessed after drug administration following an overnight withdrawal of antiparkinsonian medications. Thirty patients (age: 60 \u00b1 8 years, PD duration: 12 \u00b1 6 years, UPDRS III OFF: 37 \u00b1 15) participated. S90049 wassuperior to placebo on \u0394UPDRS III (\u221213 \u00b1 12 versus \u22127 \u00b1 9 respectively; estimated difference \u22125.2, 95% Confidence Interval (CI)[\u221210.4;0.05], <jats:italic>P<\/jats:italic> = 0.05). This was also true for secondary outcomes: number of patients switching from OFF to ON (17 on S90049 vs. 8 on placebo, <jats:italic>P<\/jats:italic> = 0.03), time to turn ON (<jats:italic>P<\/jats:italic> = 0.013) and duration of the ON phase (<jats:italic>P<\/jats:italic> = 0.03). In the 17 patients who switched ON on S90049, \u0394UPDRS III was similar on S90049 (\u221221.2 \u00b1 10.1) and apomorphine (\u221223.6 \u00b1 14.1) (estimated difference: 4.0 95% CI [\u22122.9;10.9]). S90049 was well tolerated: no serious or unexpected adverse event occurred. A single dose of up to 60 mg of S90049 given sublingually was superior to placebo in improving UPDRS III and aborting a practical OFF in patients with advanced PD. Testing greater doses might improve response rate. \u00a9 2009 Movement Disorder Society<\/jats:p>","DOI":"10.1002\/mds.22922","type":"journal-article","created":{"date-parts":[[2010,1,8]],"date-time":"2010-01-08T18:59:29Z","timestamp":1262977169000},"page":"368-376","source":"Crossref","is-referenced-by-count":22,"title":["Orodispersible sublingual piribedil to abort OFF episodes: A single dose placebo\u2010controlled, randomized, double\u2010blind, cross\u2010over study"],"prefix":"10.1002","volume":"25","author":[{"given":"Olivier","family":"Rascol","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jean\u2010Philippe","family":"Azulay","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Olivier","family":"Blin","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anne\u2010Marie","family":"Bonnet","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christine","family":"Brefel\u2010Courbon","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pierre","family":"C\u00e9saro","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Philippe","family":"Damier","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"B\u00e9reng\u00e8re","family":"Debilly","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Frank","family":"Durif","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Monique","family":"Galitzky","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jean\u2010Marie","family":"Grouin","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sylvie","family":"Pennaforte","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gabriel","family":"Villafane","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sadek","family":"Yaici","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yves","family":"Agid","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2010,2,24]]},"reference":[{"key":"e_1_2_7_2_2","doi-asserted-by":"publisher","DOI":"10.1002\/mds.20464"},{"key":"e_1_2_7_3_2","doi-asserted-by":"publisher","DOI":"10.1212\/01.wnl.0000215250.82576.87"},{"key":"e_1_2_7_4_2","doi-asserted-by":"publisher","DOI":"10.2165\/00002512-200421110-00001"},{"key":"e_1_2_7_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinthera.2005.11.016"},{"key":"e_1_2_7_6_2","doi-asserted-by":"publisher","DOI":"10.1001\/archneur.58.9.1385"},{"key":"e_1_2_7_7_2","doi-asserted-by":"publisher","DOI":"10.2165\/00003088-199937030-00004"},{"key":"e_1_2_7_8_2","doi-asserted-by":"crossref","first-page":"885","DOI":"10.1016\/S0022-3565(25)12142-3","article-title":"Functional correlates of dopamine D3 receptor activation in the rat in vivo and their modulation by the selective antagonist, (t) \u2010 S 14297: I. 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