{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T19:12:32Z","timestamp":1777489952497,"version":"3.51.4"},"reference-count":32,"publisher":"SAGE Publications","issue":"5","license":[{"start":{"date-parts":[[2010,11,8]],"date-time":"2010-11-08T00:00:00Z","timestamp":1289174400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Cephalalgia"],"published-print":{"date-parts":[[2011,4]]},"abstract":"<jats:p>Introduction: Chronic daily headache (CDH) represents a temporal profile of headache (15+ days\/month; 4+ hours\/day; &gt;6 months). We report the first comprehensive and largest levetiracetam (LEV) trial in CDH.<\/jats:p>\n                  <jats:p>Methods: A 27-week, multi-centre, randomised, placebo-controlled, cross-over, phase III B study assessed efficacy of a target of 3\u2009g\/day LEV of 6 placebo tablets\/day in CDH. Primary efficacy was headache-free rate (HFR) while secondary parameters were loss of diagnostic criteria; severity; duration; disability; associated features; pain; and quality of life.<\/jats:p>\n                  <jats:p>Results: Ninety-six patients were recruited (baseline HFR 10.4\u2009\u00b1\u200914.6%; median 0%). At onset of history 73 (74.1%) had migraine +\/\u2212 aura and 35 (36.5%) had tension-type headache (TTH). Over the six months preceding recruitment 54 (56.3%) had migraine and 42 (43.8%) had TTH. Headache history was 22.6\u2009\u00b1\u200915.0 years (median 20.0). Eighty-eight received placebo and 89 received LEV with &gt;80 receiving stable dose in either arm. LEV achieved 3.9% increased HFR over placebo, showing a trend but not significance. There was 9.9% increase in loss of CDH diagnostic criteria re: headache days\/month for LEV over placebo ( p\u2009=\u2009.0325), reduced disability ( p\u2009=\u2009.0487) and reduced pain severity for LEV ( p\u2009=\u2009.0162). The Short-Form Quality of Life assessment instrument (SF-36) showed impaired mental health on LEV ( p\u2009=\u2009.001).<\/jats:p>\n                  <jats:p>Discussion: These findings conflict with reports of LEV efficacy, mandating placebo control in headache trials. Primary efficacy equated to one extra headache-free day\/month with reduced disability and pain intensity. Mental health was reduced on LEV. The 10% loss of diagnostic criteria, decreased intensity and disability suggest a subpopulation with CDH where LEV remains a therapeutic option.<\/jats:p>","DOI":"10.1177\/0333102410384886","type":"journal-article","created":{"date-parts":[[2010,11,9]],"date-time":"2010-11-09T00:23:02Z","timestamp":1289262182000},"page":"530-536","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":39,"title":["Levetiracetam in chronic daily headache: A double-blind, randomised placebo-controlled study"],"prefix":"10.1177","volume":"31","author":[{"given":"Roy G","family":"Beran","sequence":"first","affiliation":[{"name":"Griffith University and Liverpool Hospital, Australia."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paul J","family":"Spira","sequence":"additional","affiliation":[{"name":"Institute of Neurological Sciences and Prince of Wales Hospital Australia."}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2010,11,8]]},"reference":[{"issue":"2","key":"bibr1-0333102410384886","doi-asserted-by":"crossref","first-page":"19","DOI":"10.1046\/j.1468-2982.1985.0502060.x","volume":"5","author":"Sjaastad O","year":"1985","journal-title":"Cephalalgia"},{"key":"bibr2-0333102410384886","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.47.4.871"},{"key":"bibr3-0333102410384886","doi-asserted-by":"publisher","DOI":"10.1111\/j.1468-2982.1992.00365.x"},{"key":"bibr4-0333102410384886","doi-asserted-by":"publisher","DOI":"10.1111\/j.1526-4610.1987.hed2702102.x"},{"key":"bibr5-0333102410384886","doi-asserted-by":"publisher","DOI":"10.1046\/j.1468-2982.1994.1406443.x"},{"key":"bibr6-0333102410384886","doi-asserted-by":"publisher","DOI":"10.1016\/j.jchromb.2005.01.040"},{"key":"bibr7-0333102410384886","doi-asserted-by":"publisher","DOI":"10.2165\/00003088-200443110-00002"},{"key":"bibr8-0333102410384886","doi-asserted-by":"crossref","first-page":"426","DOI":"10.1136\/jnnp.72.1.114","volume":"72","author":"Shorvon SD","year":"2002","journal-title":"J Neurol Neurosurgery Psychiatry"},{"key":"bibr9-0333102410384886","doi-asserted-by":"publisher","DOI":"10.1016\/0014-2999(92)90855-X"},{"key":"bibr10-0333102410384886","doi-asserted-by":"publisher","DOI":"10.1016\/S0014-2999(03)01933-2"},{"key":"bibr11-0333102410384886","doi-asserted-by":"publisher","DOI":"10.1213\/01.ane.0000247788.57318.1f"},{"key":"bibr12-0333102410384886","doi-asserted-by":"publisher","DOI":"10.1006\/ebeh.2001.0254"},{"key":"bibr13-0333102410384886","doi-asserted-by":"publisher","DOI":"10.1111\/j.1526-4610.1991.hed3102071.x"},{"key":"bibr14-0333102410384886","doi-asserted-by":"publisher","DOI":"10.1111\/j.1526-4610.1995.hed3509540.x"},{"key":"bibr15-0333102410384886","doi-asserted-by":"publisher","DOI":"10.1212\/01.WNL.0000100121.58594.11"},{"issue":"8","key":"bibr16-0333102410384886","doi-asserted-by":"crossref","first-page":"943","DOI":"10.1007\/s00415-004-0464-6","volume":"251","author":"Diener HC","year":"2004","journal-title":"J Neurol"},{"key":"bibr17-0333102410384886","doi-asserted-by":"publisher","DOI":"10.1111\/j.1526-4610.2006.00684.x"},{"issue":"1","key":"bibr18-0333102410384886","first-page":"9","volume":"24","author":"Headache Classification Committee of the International Headache Society","year":"2004","journal-title":"Cephalalgia"},{"key":"bibr19-0333102410384886","doi-asserted-by":"publisher","DOI":"10.1007\/s10072-004-0278-4"},{"key":"bibr20-0333102410384886","doi-asserted-by":"publisher","DOI":"10.1007\/s11916-004-0049-1"},{"key":"bibr21-0333102410384886","doi-asserted-by":"publisher","DOI":"10.1111\/j.1526-4610.2004.04053.x"},{"key":"bibr22-0333102410384886","doi-asserted-by":"publisher","DOI":"10.1111\/j.1526-4610.2007.00728.x"},{"key":"bibr23-0333102410384886","doi-asserted-by":"publisher","DOI":"10.1007\/s10194-003-0043-8"},{"key":"bibr24-0333102410384886","doi-asserted-by":"publisher","DOI":"10.1097\/01.WNF.0000236766.08409.03"},{"key":"bibr25-0333102410384886","doi-asserted-by":"publisher","DOI":"10.1016\/j.curtheres.2005.06.006"},{"key":"bibr26-0333102410384886","doi-asserted-by":"publisher","DOI":"10.1111\/j.1526-4610.2008.01292.x"},{"key":"bibr27-0333102410384886","doi-asserted-by":"publisher","DOI":"10.1016\/S1525-5050(03)00005-2"},{"key":"bibr28-0333102410384886","doi-asserted-by":"publisher","DOI":"10.1212\/01.WNL.0000091865.46063.67"},{"key":"bibr29-0333102410384886","first-page":"471","volume":"13","author":"Moerman DE","year":"2002","journal-title":"Intern Med"},{"key":"bibr30-0333102410384886","doi-asserted-by":"publisher","DOI":"10.1111\/j.1468-2982.2008.01660.x"},{"key":"bibr31-0333102410384886","doi-asserted-by":"publisher","DOI":"10.1007\/s10194-007-0360-4"},{"key":"bibr32-0333102410384886","doi-asserted-by":"publisher","DOI":"10.1046\/j.1468-2982.2003.00530.x"}],"container-title":["Cephalalgia"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/0333102410384886","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/0333102410384886","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/0333102410384886","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T14:45:34Z","timestamp":1777387534000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/0333102410384886"}},"subtitle":["(The Australian KEPPRA Headache Trial [AUS-KHT])"],"short-title":[],"issued":{"date-parts":[[2010,11,8]]},"references-count":32,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2011,4]]}},"alternative-id":["10.1177\/0333102410384886"],"URL":"https:\/\/doi.org\/10.1177\/0333102410384886","relation":{},"ISSN":["0333-1024","1468-2982"],"issn-type":[{"value":"0333-1024","type":"print"},{"value":"1468-2982","type":"electronic"}],"subject":[],"published":{"date-parts":[[2010,11,8]]}}}