{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T03:14:24Z","timestamp":1792034064749,"version":"4.4.0"},"reference-count":33,"publisher":"SAGE Publications","issue":"1","license":[{"start":{"date-parts":[[2022,3,29]],"date-time":"2022-03-29T00:00:00Z","timestamp":1648512000000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["PRM"],"published-print":{"date-parts":[[2022,3,29]]},"abstract":"<jats:p>PURPOSE: The open-label phase 3 \u201cTreatment with IncobotulinumtoxinA in Movement Open-Label\u201d (TIMO) study investigated longer-term safety and efficacy of incobotulinumtoxin A in children\/adolescents with cerebral palsy (CP). METHODS: Patients on standard treatment, with unilateral or bilateral lower limb (LL) or combined upper limb (UL)\/LL spasticity received four incobotulinumtoxinA injection cycles (16 or 20 Units\/kg bodyweight total [maximum 400 or 500 Units] per cycle depending on ambulatory status\/clinical pattern treated), each followed by 12\u201316 weeks\u2019 observation. Treatment for pes equinus was mandatory; flexed knee or adducted thigh were options for unilateral treatment and\/or ULs for unilateral\/bilateral treatment. The primary endpoint was safety; changes in Ashworth Scale and Gross Motor Function Measure-66 scores, and Global Impression of Change Scale scores at week 4 of each injection cycle were also evaluated. RESULTS: IncobotulinumtoxinA (\u2264500 Units for \u226498 weeks) was safe, well-tolerated, and effective across all endpoints for multipattern treatment of LL and combined LL\/UL spasticity in ambulant\/nonambulant children\/adolescents with CP. Treatment effects increased with each injection cycle. No new\/unexpected safety concerns were identified. CONCLUSION: IncobotulinumtoxinA showed a good safety and tolerability profile, with efficacy over multiple clinical presentations. As an adjunct treatment, it offers an effective, individualized treatment option for pediatric CP-related spasticity.<\/jats:p>","DOI":"10.3233\/prm-210041","type":"journal-article","created":{"date-parts":[[2021,12,24]],"date-time":"2021-12-24T10:40:04Z","timestamp":1640342404000},"page":"113-127","source":"Crossref","is-referenced-by-count":11,"title":["Safety and efficacy of repeat long-term incobotulinumtoxinA treatment for lower limb or combined upper\/lower limb spasticity in children with cerebral palsy"],"prefix":"10.1177","volume":"15","author":[{"given":"Petr","family":"Ka\u0148ovsk\u00fd","sequence":"first","affiliation":[{"name":"Faculty of Medicine and Dentistry and University Hospital, Palack\u00fd University Olomouc, Olomouc, Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Florian","family":"Heinen","sequence":"additional","affiliation":[{"name":"Department of Pediatric Neurology & Developmental Medicine and LMU Center for Children with Medical Complexity, Dr.von Hauner Children\u2019s Hospital, Ludwig-Maximilians-University Munich, Munich, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A. 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