{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,6]],"date-time":"2025-11-06T20:03:11Z","timestamp":1762459391834,"version":"build-2065373602"},"reference-count":20,"publisher":"Oxford University Press (OUP)","issue":"3","funder":[{"DOI":"10.13039\/100006436","name":"Celgene Corporation","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100006436","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2017,3,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Objective. This phase II study assessed lenalidomide efficacy and safety.<\/jats:p>\n                  <jats:p>Design. Three-phase core study: 14-day prerandomization, 12-week treatment, and 52-week open-label extension.<\/jats:p>\n                  <jats:p>Setting. Fourteen US centers from July 2005\u2009to\u2009July 2007.<\/jats:p>\n                  <jats:p>Subjects. Chronic lumbar radicular pain patients without history of nerve injury or deficit.<\/jats:p>\n                  <jats:p>Methods. Subjects were randomized (1:1) to double-blind treatment with lenalidomide 10\u2009mg or placebo once daily for 12 weeks, followed by a 52-week open-label extension. A 12-week, single-center, randomized-withdrawal (1:2, lenalidomide:placebo), exploratory study with open-label extension was undertaken in 12 subjects from the core extension who were na\u00efve to neuropathic medications and with at least a two-point decrease from baseline average daily Pain Intensity\u2013Numerical Rating Scale score.<\/jats:p>\n                  <jats:p>Results. Of 180 subjects enrolled, 176 had at least one postbaseline measure; 132 completed the 12-week treatment phase. In the core study, no statistically significant difference in Pain Intensity\u2013Numerical Rating Scale mean change (\u22120.02, P\u2009=\u20090.958) was observed at week 12 between lenalidomide and placebo; proportions achieving pain reduction at week 12 and other secondary measures were comparable between lenalidomide and placebo. In the exploratory study, week 12 mean changes in Pain Intensity\u2013Numerical Rating Scale scores were \u22120.05 (lenalidomide: N\u2009=\u20093) and 2.11 (placebo: N\u2009=\u20098). Mean changes in Brief Pain Inventory\u2013short form interference scores were \u22123.33 and 8.38, respectively; scores at six months were maintained or decreased in 10 of 12 subjects.<\/jats:p>\n                  <jats:p>Conclusions. While this study does not support lenalidomide use in an unselected lumbar radicular pain population, an immunomodulating agent may relieve pain in select subjects na\u00efve to neuropathic pain medications.<\/jats:p>\n                  <jats:p>ClinicalTrials.gov identifier: NCT00120120.<\/jats:p>","DOI":"10.1093\/pm\/pnw212","type":"journal-article","created":{"date-parts":[[2016,8,22]],"date-time":"2016-08-22T22:39:10Z","timestamp":1471905550000},"page":"477-487","source":"Crossref","is-referenced-by-count":1,"title":["A Phase II Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Lenalidomide in Lumbar Radicular Pain with a Long-Term Open-Label Extension Phase"],"prefix":"10.1093","volume":"18","author":[{"given":"Donald C.","family":"Manning","sequence":"first","affiliation":[{"name":"*Adynxx Inc, San Francisco, California"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joseph","family":"Gimbel","sequence":"additional","affiliation":[{"name":"\u2020Arizona Research Center, Phoenix, Arizona"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert","family":"Wertz","sequence":"additional","affiliation":[{"name":"\u2021Center for Pain Management, Lehigh Valley Hospital, Allentown, Pennsylvania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Richard","family":"Rauck","sequence":"additional","affiliation":[{"name":"\u00a7Carolinas Pain Institute, P.A. & the Center for Clinical Research, LLC, Winston-Salem, North Carolina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alyse","family":"Cooper","sequence":"additional","affiliation":[{"name":"\u00b6Clinical Research, Celgene Corporation, Summit, New Jersey"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jerome 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