{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T15:11:56Z","timestamp":1791299516750,"version":"4.1.0"},"reference-count":30,"publisher":"SAGE Publications","issue":"2","license":[{"start":{"date-parts":[[2011,8,30]],"date-time":"2011-08-30T00:00:00Z","timestamp":1314662400000},"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":["Mult Scler"],"published-print":{"date-parts":[[2012,2]]},"abstract":"<jats:p>Background: Open-label studies are not ideal for providing robust evidence for long-term maintenance of efficacy of medicines, especially where medicines provide symptom relief and where long-term use of a placebo may be problematic and not ethical.<\/jats:p>\n                  <jats:p>Objective: To evaluate the maintenance of efficacy of Sativex in subjects who have gained long-term symptomatic relief of spasticity in multiple sclerosis (MS), and to assess the impact of sudden medicine withdrawal.<\/jats:p>\n                  <jats:p>Methods: An enriched enrolment randomized withdrawal study design was used. Eligible subjects with ongoing benefit from Sativex for at least 12 weeks entered this 5-week placebo-controlled, parallel-group, randomized withdrawal study. Each subjects\u2019 previous effective and tolerated dose was continued.<\/jats:p>\n                  <jats:p>Results: A total of 18 subjects per group were enrolled. Demographics showed a mean duration of MS of 16.4 years, spasticity 12.7 years, mean duration of Sativex use of 3.6 years (median 3.4 years) and a mean daily dose of 8.25 sprays. Primary outcome of time to treatment failure was significantly in favour of Sativex ( p = 0.013). Secondary endpoints showed significant changes in the Carer and Subject\u2019s Global Impression of Change scales in favour of Sativex.<\/jats:p>\n                  <jats:p>Conclusions: Maintenance of Sativex efficacy in long-term symptomatic improvement of spasticity to a group of subjects with MS has been confirmed using this study design.<\/jats:p>","DOI":"10.1177\/1352458511419700","type":"journal-article","created":{"date-parts":[[2011,8,30]],"date-time":"2011-08-30T20:34:54Z","timestamp":1314736494000},"page":"219-228","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":130,"title":["A placebo-controlled, parallel-group, randomized withdrawal study of subjects with symptoms of spasticity due to multiple sclerosis who are receiving long-term Sativex\u00ae (nabiximols)"],"prefix":"10.1177","volume":"18","author":[{"given":"W","family":"Notcutt","sequence":"first","affiliation":[{"name":"James Paget University Hospital, Pain Management Department, Gorleston on Sea, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R","family":"Langford","sequence":"additional","affiliation":[{"name":"St. Bartholomew\u2019s Hospital, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P","family":"Davies","sequence":"additional","affiliation":[{"name":"Northampton General Hospital, Department of Neurology, Northampton, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S","family":"Ratcliffe","sequence":"additional","affiliation":[{"name":"MAC UK Neuroscience Ltd, Manchester, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R","family":"Potts","sequence":"additional","affiliation":[{"name":"GW Pharma Ltd, Salisbury, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2011,8,30]]},"reference":[{"key":"bibr1-1352458511419700","doi-asserted-by":"publisher","DOI":"10.1191\/1352458504ms1085oa"},{"key":"bibr2-1352458511419700","doi-asserted-by":"publisher","DOI":"10.1136\/jnnp.2006.101196"},{"key":"bibr3-1352458511419700","doi-asserted-by":"publisher","DOI":"10.1007\/s00415-005-5002-7"},{"key":"bibr4-1352458511419700","first-page":"6","volume":"2","author":"Kesselring J","year":"2002","journal-title":"Adv Clin Neurosci Rehabil"},{"issue":"3","key":"bibr5-1352458511419700","author":"Shakespeare DT","year":"2001","journal-title":"The Cochrane Library"},{"key":"bibr6-1352458511419700","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.41.11.1829"},{"key":"bibr7-1352458511419700","doi-asserted-by":"publisher","DOI":"10.3310\/hta7400"},{"key":"bibr8-1352458511419700","first-page":"512","volume":"44","author":"Young RR","year":"1994","journal-title":"Neurology"},{"key":"bibr9-1352458511419700","doi-asserted-by":"publisher","DOI":"10.1080\/09638280400014576"},{"key":"bibr10-1352458511419700","doi-asserted-by":"publisher","DOI":"10.1080\/09638280400014683"},{"key":"bibr11-1352458511419700","first-page":"485","volume-title":"Spasticity disordered motor control","author":"Lance J","year":"1980"},{"key":"bibr12-1352458511419700","unstructured":"House of Lords Select Committee on Science and Technology. 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Choice of Control Group and Related Issues in Clinical Trials \u2013 Guidance for Industry. 2001. www.fda.gov\/RegulatoryInformation\/Guidances\/ucm125802.htm."},{"key":"bibr25-1352458511419700","doi-asserted-by":"publisher","DOI":"10.1177\/009286158201600102"},{"key":"bibr26-1352458511419700","first-page":"239","volume":"13","author":"Serpell MG","year":"2006","journal-title":"Eur J Neurol"},{"key":"bibr27-1352458511419700","doi-asserted-by":"publisher","DOI":"10.1126\/scitranslmed.3001244"},{"key":"bibr28-1352458511419700","doi-asserted-by":"publisher","DOI":"10.1097\/01.yco.0000218592.00689.e5"},{"key":"bibr29-1352458511419700","doi-asserted-by":"publisher","DOI":"10.1179\/016164109X12590518685660"},{"key":"bibr30-1352458511419700","doi-asserted-by":"publisher","DOI":"10.1111\/j.1468-1331.2010.03328.x"}],"container-title":["Multiple Sclerosis Journal"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/1352458511419700","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/1352458511419700","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/1352458511419700","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,2]],"date-time":"2026-05-02T03:32:12Z","timestamp":1777692732000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/1352458511419700"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2011,8,30]]},"references-count":30,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2012,2]]}},"alternative-id":["10.1177\/1352458511419700"],"URL":"https:\/\/doi.org\/10.1177\/1352458511419700","relation":{},"ISSN":["1352-4585","1477-0970"],"issn-type":[{"value":"1352-4585","type":"print"},{"value":"1477-0970","type":"electronic"}],"subject":[],"published":{"date-parts":[[2011,8,30]]}}}