{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,30]],"date-time":"2026-07-30T16:56:57Z","timestamp":1785430617150,"version":"3.56.0"},"reference-count":41,"publisher":"MDPI AG","issue":"7","license":[{"start":{"date-parts":[[2026,7,15]],"date-time":"2026-07-15T00:00:00Z","timestamp":1784073600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Teijin Pharma Limited"},{"id":[{"id":"https:\/\/ror.org\/001144c36","id-type":"ROR","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Neurology International"],"abstract":"<jats:p>Background: This prospective, multicenter, open-label, single-arm study (jRCT2031230690) evaluated the efficacy and safety of a tailored dosing strategy of incobotulinumtoxinA, including high doses (up to 500 U) and flexible injection intervals (as short as 6 weeks), in Japanese patients with cervical dystonia (CD). Methods: Of 30 enrolled patients, Group A included 27 patients with idiopathic CD for the primary evaluation of efficacy and safety, whereas Group B included 3 patients with tardive dyskinesia (cervical) or tardive CD for exploratory safety assessment. Patients received up to seven injection cycles of incobotulinumtoxinA (120\u2013500 U) over 48 weeks, with minimum 6-week intervals. The primary endpoint, evaluated in Group A, was the change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score from baseline to Week 4 after the first injection. Results: Using a mixed model for repeated measures, the least squares mean \u00b1 standard error of the change was \u221211.0 \u00b1 1.77 (95% confidence interval: \u221214.6, \u22127.3). The primary efficacy endpoint was achieved in Group A. Due to the small sample size (n = 3), efficacy in Group B was evaluated only for exploratory purposes, although safety findings were broadly consistent with those in Group A. The overall safety profile was consistent with previous studies. Across the study, the most common related adverse events were dysphagia (33.3%) and muscular weakness (22.2%) in Group A and dysphagia (33.3%) in Group B. All cases of dysphagia were mild to moderate in severity and transient, with no apparent dose- or injection interval-related trend observed. Conclusions: IncobotulinumtoxinA was associated with improvements in symptoms and manageable safety profile at high doses and flexible injection intervals in Japanese patients with CD. While these findings suggest a potential treatment option for individualized dose optimization, the absence of a control group and the exploratory nature of the assessment in Group B necessitate cautious interpretation.<\/jats:p>","DOI":"10.3390\/neurolint18070136","type":"journal-article","created":{"date-parts":[[2026,7,16]],"date-time":"2026-07-16T01:05:07Z","timestamp":1784163907000},"page":"136","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Efficacy and Safety of a Tailored Dosing Strategy with High-Dose IncobotulinumtoxinA at Flexible Injection Intervals for Cervical Dystonia: An Open-Label, Uncontrolled, Single-Arm Study in Japan"],"prefix":"10.3390","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0009-0002-1687-3845","authenticated-orcid":false,"given":"Akira","family":"Tamagawa","sequence":"first","affiliation":[{"name":"Tamagawa Clinic, Yokohama 241-0814, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masahiro","family":"Horiuchi","sequence":"additional","affiliation":[{"name":"Hakone Rehabilitation Hospital Attached Yuiodawara Clinic, Odawara 250-0055, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takenori","family":"Abe","sequence":"additional","affiliation":[{"name":"Department of Neurology, Nakamura Memorial Hospital, Sapporo 060-8570, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shinichi","family":"Matsumoto","sequence":"additional","affiliation":[{"name":"Department of Neurology, Osaka Neurological Institute, Toyonaka 561-0836, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2930-5003","authenticated-orcid":false,"given":"Yohei","family":"Mukai","sequence":"additional","affiliation":[{"name":"Department of Neurology, National Center of Neurology and Psychiatry, Kodaira 187-8551, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kunihiko","family":"Ikeguchi","sequence":"additional","affiliation":[{"name":"Jichi-idai Station Brain Clinic, Shimotsuke 329-0403, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomoo","family":"Mano","sequence":"additional","affiliation":[{"name":"Department of Rehabilitation, Nara Prefectural General Medical Center, Nara 630-8054, Japan"},{"name":"Department of Neurology, Nara Medical University, Kashihara 634-8521, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5103-7784","authenticated-orcid":false,"given":"Masahito","family":"Mihara","sequence":"additional","affiliation":[{"name":"Department of Neurology, Kawasaki Medical School, Kurashiki 701-0192, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kimiyoshi","family":"Arimura","sequence":"additional","affiliation":[{"name":"Ookatsu Neurology and Rehabilitation Hospital, Kagoshima 890-0067, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kotaro","family":"Asanuma","sequence":"additional","affiliation":[{"name":"Yanaginobanba Takeda Clinic, Kyoto 604-8113, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kanako","family":"Kurihara","sequence":"additional","affiliation":[{"name":"Department of Neurology, Faculty of Medicine, Fukuoka University, Fukuoka 814-0180, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sonoko","family":"Misawa","sequence":"additional","affiliation":[{"name":"Department of Neurology, Graduate School of Medicine, Chiba University, Chiba 260-8670, Japan"},{"name":"Department of Neurology and Neurological Science, Institute of Science Tokyo, Bunkyo-ku 113-8519, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6434-9541","authenticated-orcid":false,"given":"Ryosuke","family":"Miyamoto","sequence":"additional","affiliation":[{"name":"Department of Neurology, Tokushima University Graduate School of Biomedical Sciences, Tokushima 770-8503, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7762-3597","authenticated-orcid":false,"given":"Noriko","family":"Nishikawa","sequence":"additional","affiliation":[{"name":"Department of Neurology, Juntendo University Faculty of Medicine, Bunkyo-ku 113-8421, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuzuru","family":"Sasaki","sequence":"additional","affiliation":[{"name":"Clinical Development Department, Teijin Pharma Limited, Chiyoda-ku 100-8585, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shohei","family":"Tateishi","sequence":"additional","affiliation":[{"name":"Clinical Development Control Department, Teijin Pharma Limited, Chiyoda-ku 100-8585, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yusaku","family":"Nakamura","sequence":"additional","affiliation":[{"name":"Department of Neurology, Rinku General Medical Center, Izumisano 598-8577, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,7,15]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"1167","DOI":"10.1086\/444507","article-title":"Botulism","volume":"41","author":"Sobel","year":"2005","journal-title":"Clin. 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