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Originally granted orphan drug status, marketing authorisation was obtained on the basis of a randomised, double\u2010blind, placebo\u2010controlled trial conducted in 138 LGS patients. An open\u2010label extension study subsequently demonstrated that rufinamide's efficacy and tolerability were maintained over the longer term (median duration of treatment, 432 days). Recently published reports from Europe and the United States have described the use of adjunctive rufinamide to treat LGS in clinical practice. These data complement the clinical trial results, by providing information on the efficacy and tolerability of rufinamide when used on an individualised basis in real\u2010world practice, under less tightly restricted conditions in terms of patient population and dosing strategies. A comparison of the data reveals that a \u201clower and slower\u201d dosing strategy tends to be adopted in clinical practice, in comparison with the clinical trial, which does not appear to compromise efficacy, but may provide improvements in tolerability. Individual case reports provide additional valuable information on how rufinamide is being used to treat different seizure types associated with LGS. Since clinical experience with rufinamide is currently at an early stage, there are still unanswered questions relating to its use, and it is likely that its place in the adjunctive treatment of LGS will evolve as further data emerge.<\/jats:p>","DOI":"10.1684\/epd.2011.0421","type":"journal-article","created":{"date-parts":[[2019,8,2]],"date-time":"2019-08-02T13:24:19Z","timestamp":1564752259000},"source":"Crossref","is-referenced-by-count":8,"title":["Rufinamide from clinical trials to clinical practice in the United States and Europe"],"prefix":"10.1002","volume":"13","author":[{"given":"Trevor","family":"Resnick","sequence":"first","affiliation":[{"name":"Department of Neurology Miami Children's Hospital Miami Florida USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alexis","family":"Arzimanoglou","sequence":"additional","affiliation":[{"name":"Institute for Children and Adolescents with Epilepsy \u2013 IDEE University Hospital of Lyon and Inserm\u2010U821 Lyon France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lawrence W.","family":"Brown","sequence":"additional","affiliation":[{"name":"Children's Hospital of Philadelphia Philadelphia PA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert","family":"Flamini","sequence":"additional","affiliation":[{"name":"Children's Epilepsy Center Children's Healthcare of Atlanta Child Neurology Associates PC Atlanta GA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael","family":"Kerr","sequence":"additional","affiliation":[{"name":"Welsh Centre for Learning Disabilities Cardiff University Cardiff Wales United Kingdom"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gerhard","family":"Kluger","sequence":"additional","affiliation":[{"name":"Epilepsy Centre for Children and Adolescents Sch\u00f6n Klinik Vogtareuth Vogtareuth Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sanjeev","family":"Kothare","sequence":"additional","affiliation":[{"name":"Children's Hospital Boston Boston USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sunny","family":"Philip","sequence":"additional","affiliation":[{"name":"Spire Leicester Hospital Leicester United Kingdom"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Miranda","family":"Harrison","sequence":"additional","affiliation":[{"name":"Eisai Knowledge Centre Mosquito Way Hatfield United Kingdom"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Milind","family":"Narurkar","sequence":"additional","affiliation":[{"name":"Eisai, Inc Woodcliff Lake NJ USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2011,5]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(08)70292-8"},{"key":"e_1_2_9_3_1","unstructured":"AwadhM JainV VoraN et al.Scottish experience with rufinamide in children with refractory drop attacks. 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