{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,7]],"date-time":"2026-11-07T11:07:30Z","timestamp":1794049650954,"version":"4.8.0"},"reference-count":30,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2020,4,27]],"date-time":"2020-04-27T00:00:00Z","timestamp":1587945600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Develop Med Child Neuro"],"published-print":{"date-parts":[[2020,9]]},"abstract":"<jats:sec><jats:title>Aim<\/jats:title><jats:p>To assess the efficacy, safety, and tolerability of oromucosal nabiximols cannabinoid medicine as adjunct therapy for children with spasticity due to cerebral palsy\/traumatic central nervous system injury with inadequate response to existing treatment.<\/jats:p><\/jats:sec><jats:sec><jats:title>Method<\/jats:title><jats:p>Overall, 72 patients (mean [SD] age 12y 4mo [3y 1mo], range 8\u201218y) were randomized at a ratio of 2:1 to receive nabiximols (<jats:italic>n<\/jats:italic>=47; 29 males, 18 females) or placebo (<jats:italic>n<\/jats:italic>=25; 15 males, 10 females) for 12 weeks (12\u00a0sprays\/day max. based on clinical response\/tolerability). The primary outcome was change from baseline in level of spasticity on a 0 to 10 Numerical Rating Scale (NRS), assessed by the primary caregiver at 12\u00a0weeks. Secondary outcomes included additional measures for spasticity, sleep quality, pain, health\u2010related quality of life, comfort, depression, and safety.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>There was no significant difference in the spasticity 0 to 10 NRS between nabiximols versus placebo groups after 12\u00a0weeks. No statistically significant differences were observed for any secondary endpoint. Adverse events were predominantly mild or moderate in severity; however, three cases of hallucinations were reported.<\/jats:p><\/jats:sec><jats:sec><jats:title>Interpretation<\/jats:title><jats:p>Nabiximols was generally well tolerated; however, neuropsychiatric adverse events were observed. No significant reduction in spasticity with nabiximols treatment versus placebo was observed.<\/jats:p><\/jats:sec><jats:sec><jats:title>What this paper adds<\/jats:title><jats:p>\n<jats:list list-type=\"bullet\">\n\n<jats:list-item><jats:p>Oromucosal nabiximols is generally well tolerated by paediatric patients.<\/jats:p><\/jats:list-item>\n\n<jats:list-item><jats:p>However, three cases of hallucinations were observed, one of which involved auditory hallucinations and a suicide attempt.<\/jats:p><\/jats:list-item>\n\n<jats:list-item><jats:p>Oromucosal nabiximols versus placebo did not reduce cerebral palsy\/central nervous system injury\u2010related spasticity.<\/jats:p><\/jats:list-item>\n<\/jats:list>\n<\/jats:p><\/jats:sec>","DOI":"10.1111\/dmcn.14548","type":"journal-article","created":{"date-parts":[[2020,4,28]],"date-time":"2020-04-28T05:28:27Z","timestamp":1588051707000},"page":"1031-1039","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":41,"title":["Efficacy and safety of nabiximols cannabinoid medicine for paediatric spasticity in cerebral palsy or traumatic brain injury: a randomized controlled trial"],"prefix":"10.1111","volume":"62","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9534-0563","authenticated-orcid":false,"given":"Charlie","family":"Fairhurst","sequence":"first","affiliation":[{"name":"Department of Paediatric Neurosciences Evelina London Children\u2019s Hospital Guy\u2019s and St Thomas\u2019 NHS Foundation Trust London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ram","family":"Kumar","sequence":"additional","affiliation":[{"name":"Department of Paediatric Neurology Alder Hey Children\u2019s Hospital Liverpool UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Checketts","sequence":"additional","affiliation":[{"name":"GW Research Ltd Cambridge UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bola","family":"Tayo","sequence":"additional","affiliation":[{"name":"GW Research Ltd Cambridge UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susie","family":"Turner","sequence":"additional","affiliation":[{"name":"Department of Paediatric Neurosciences Evelina London Children\u2019s Hospital Guy\u2019s and St Thomas\u2019 NHS Foundation Trust London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,4,27]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.pnpbp.2015.07.001"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1007\/s13311-015-0376-4"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/bs.apha.2017.03.007"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1177\/1179573519831997"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(19)30032-8"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/dmcn.14165"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.pain.2004.09.013"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1212\/01.wnl.0000176753.45410.8b"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.pain.2007.08.028"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1468-1331.2010.03328.x"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1177\/1352458511419700"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00415-012-6739-4"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2017-016843"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1080\/00207454.2018.1481066"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00415-012-6634-z"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.3390\/molecules23102478"},{"key":"e_1_2_8_18_1","volume-title":"Declaration of Helsinki. 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