{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,26]],"date-time":"2026-06-26T02:17:10Z","timestamp":1782440230449,"version":"3.54.5"},"reference-count":0,"publisher":"S. Karger AG","issue":"Suppl. 1","license":[{"start":{"date-parts":[[2016,1,1]],"date-time":"2016-01-01T00:00:00Z","timestamp":1451606400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/karger.com\/pages\/terms-and-conditions"},{"start":{"date-parts":[[2016,1,1]],"date-time":"2016-01-01T00:00:00Z","timestamp":1451606400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/karger.com\/pages\/terms-and-conditions"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Eur Neurol"],"published-print":{"date-parts":[[2016]]},"abstract":"<jats:p>Background: In Italy, all prescriptions for THC:CBD oromucosal spray for treatment of multiple sclerosis (MS) spasticity are linked to the official Agenzia Italiana del Farmaco (AIFA) web-based registry, which tracks the effectiveness and tolerability of medications in a prospective and observational manner. Methods: AIFA e-registry data for THC:CBD oromucosal spray collected between January 2014 and February 2015 for 1,534 patients from 30 large Italian specialized MS centres were compiled. Patients had a long disease history (17.6 \u00b1 8.6 years) and significant impairment (mean Expanded Disability Status Scale score 6.4 \u00b1 1.2). MS spasticity was evaluated using the 0-10 numerical rating scale (NRS). Results: After the first month titration and trial period, 61.9% of patients achieved sufficient improvement in spasticity (\u226520% NRS) to qualify for continued treatment. After 6 months, clinically meaningful \u226530% NRS improvement was recorded in 40.2% of patients continuing with treatment. Spasticity-associated symptoms such as cramps and nocturnal spasms improved in most responding patients. Mean reported doses of THC:CBD oromucosal spray (6.2-6.7 sprays\/day) were lower than those reported in clinical trials. Adverse events (mainly mild to moderate) were reported by 15% of patients; no new safety concerns beyond the approved label were identified. Conclusion: The results of the AIFA e-registry analysis align with those of other THC:CBD observational projects and reaffirm the characteristics of this therapeutic option in the management of treatment-resistant MS spasticity, a frequently overlooked symptom.<\/jats:p>","DOI":"10.1159\/000444236","type":"journal-article","created":{"date-parts":[[2016,2,22]],"date-time":"2016-02-22T22:01:22Z","timestamp":1456178482000},"page":"9-12","source":"Crossref","is-referenced-by-count":7,"title":["Health Authorities Data Collection of THC:CBD Oromucosal Spray (L'Agenzia Italiana del Farmaco Web Registry): Figures after 1.5 Years"],"prefix":"10.1159","volume":"75","author":[{"given":"Francesco","family":"Patti","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"127","published-online":{"date-parts":[[2016,2,23]]},"container-title":["European Neurology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/karger.com\/ene\/article-pdf\/75\/Suppl.%201\/9\/4006917\/000444236.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/karger.com\/ene\/article-pdf\/75\/Suppl.%201\/9\/4006917\/000444236.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,4,23]],"date-time":"2025-04-23T17:45:30Z","timestamp":1745430330000},"score":1,"resource":{"primary":{"URL":"https:\/\/karger.com\/article\/doi\/10.1159\/000444236"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2016]]},"references-count":0,"journal-issue":{"issue":"Suppl. 1","published-online":{"date-parts":[[2016,2,1]]},"published-print":{"date-parts":[[2016,1,1]]}},"URL":"https:\/\/doi.org\/10.1159\/000444236","archive":["Portico"],"relation":{},"ISSN":["0014-3022","1421-9913"],"issn-type":[{"value":"0014-3022","type":"print"},{"value":"1421-9913","type":"electronic"}],"subject":[],"published":{"date-parts":[[2016]]}}}