{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,25]],"date-time":"2026-09-25T19:20:59Z","timestamp":1790364059040,"version":"4.1.0"},"reference-count":28,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2026,3,23]],"date-time":"2026-03-23T00:00:00Z","timestamp":1774224000000},"content-version":"vor","delay-in-days":81,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,1,1]],"date-time":"2026-01-01T00:00:00Z","timestamp":1767225600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Journal of Diabetes Research"],"published-print":{"date-parts":[[2026,1]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>The HSK16149\u2010201\/301 trial demonstrated short\u2010term efficacy of the GABA analog crisugabalin for diabetic neuropathic pain.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In the current study, patients in both the crisugabalin and placebo control groups of the HSK16149\u2010201\/301 trial were invited to receive 80\u2009mg\/day crisugabalin for an additional 52 weeks. The primary end point was safety. The secondary end point was pain control as measured using the Short\u2010Form McGill Pain Questionnaire (SF\u2010MPQ). A total of 301 patients (mean age 59.7 years and males 58.1%) were enrolled.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      The rate of treatment\u2010related adverse events (TRAEs) was 38.9% (117\/301). The most frequent TRAEs were dizziness (27.2%), somnolence (8.3%), and peripheral edema (3.0%). The rate of Grade 3 or higher TRAEs was 1.7%. TRAEs led to dose reduction in 41 patients (13.6%), treatment interruption and discontinuation each in three patients (1.0%). At week 52, the mean difference in SF\u2010MPQ pain rating index (PRI) and visual analog scale pain score from baseline was \u22122.5 (95% CI \u22122.9 to \u22122.0; paired\n                      <jats:italic>t<\/jats:italic>\n                      \u2010test\n                      <jats:italic>p<\/jats:italic>\n                      &lt; 0.0001) and \u221223.4 (95% CI \u221225.6 to \u221221.2; paired\n                      <jats:italic>t<\/jats:italic>\n                      \u2010test\n                      <jats:italic>p<\/jats:italic>\n                      &lt; 0.0001), respectively. The proportion of patients with SF\u2010MPQ PPI score \u2264 1 increased by 19.0% over baseline (\n                      <jats:italic>p<\/jats:italic>\n                      &lt; 0.0001).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>In summary, crisugabalin at 80\u2009mg\/day was well tolerated and demonstrated sustained analgesic activities.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial Registration<\/jats:title>\n                    <jats:p>ClinicalTrials.gov identifier: NCT05890053<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1155\/jdr\/2960736","type":"journal-article","created":{"date-parts":[[2026,3,23]],"date-time":"2026-03-23T17:53:12Z","timestamp":1774288392000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Long\u2010Term Safety and Efficacy of Crisugabalin for Diabetic Peripheral Neuropathic Pain: A 52\u2010Week, Multicenter, Single\u2010Arm 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