IncobotulinumtoxinA efficacy/safety in upper-limb spasticity in pediatric cerebral palsy : randomized controlled trial
| Autor: | Hanna Dersch, Thorin L. Geister, Edward Dabrowski, Deborah Gaebler-Spira, Henry G. Chambers, Florian Heinen, Michael Althaus, Petr Kaňovský, Marta Banach |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Male
medicine.medical_specialty Adolescent Phases of clinical research law.invention Cerebral palsy Upper Extremity 03 medical and health sciences 0302 clinical medicine Double-Blind Method Developmental Neuroscience Randomized controlled trial law 030225 pediatrics Outcome Assessment Health Care medicine Humans Spasticity Botulinum Toxins Type A Child Adverse effect business.industry Cerebral Palsy Incidence (epidemiology) Gross Motor Function Classification System medicine.disease medicine.anatomical_structure Neuromuscular Agents Neurology Muscle Spasticity Child Preschool Pediatrics Perinatology and Child Health Physical therapy Upper limb Female Neurology (clinical) medicine.symptom business 030217 neurology & neurosurgery |
| ISSN: | 0200-2884 |
| Popis: | Background This randomized phase 3 study with double-blind main period (MP) and open-label extension (OLEX; NCT02002884 ) assessed incobotulinumtoxinA safety and efficacy for pediatric upper-limb spasticity treatment in ambulant/nonambulant (Gross Motor Function Classification System [GMFCS] I-V) patients, with the option of combined upper- and lower-limb treatment. Methods Patients were aged two to 17 years with unilateral or bilateral spastic cerebral palsy (CP) and Ashworth Scale (AS) score ≥2 in treatment-selected clinical patterns. In the MP, patients were randomized (2:1:1) to incobotulinumtoxinA 8, 6, or 2 U/kg body weight (maximum 200, 150, 50 U/upper limb), with optional lower-limb injections in one of five topographical distributions (total body dose ≤16 to 20 U/kg, maximum 400 to 500 U, depending on body weight and GMFCS level). In the OLEX, patients received three further treatment cycles, at the highest MP doses (8 U/kg/upper limb group). Outcomes included AS, Global Impression of Change Scale (GICS), and adverse events (AEs). Results AS scores improved from baseline to week 4 in all MP dose groups (n = 350); patients in the incobotulinumtoxinA 8 U/kg group had significantly greater spasticity improvements versus the 2 U/kg group (least-squares mean [standard error] for upper-limb main clinical target pattern −1.15 [0.06] versus −0.93 [0.08]; P = 0.017). Investigator's, child/adolescent's, and parent/caregiver's GICS scores showed improvements in all groups. Treatment benefits were sustained over further treatment cycles. AE incidence did not increase with dose or repeated treatment across GMFCS levels. Conclusions Data provide evidence for sustained efficacy and safety of multipattern incobotulinumtoxinA treatment in children and adolescents with upper-limb spasticity. |
| Databáze: | OpenAIRE |
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