Can I read IncobotulinumtoxinA for the treatment of lower-limb spasticity in children and adolescents with cerebral palsy: A phase 3 study^1^ on EtoBox?
IncobotulinumtoxinA for the treatment of lower-limb spasticity in children and adolescents with cerebral palsy: A phase 3 study^1^ by Florian Heinen; Petr Kanovský; A. Sebastian Schroeder; Henry G. Chambers; Edward Dabrowski; Thorin L. Geister; Angelika Hanschmann; Francisco J. Martinez-Torres; Irena Pulte; Marta Banach; Deborah Gaebler-Spira is a Medicine article available to read on EtoBox.
What is IncobotulinumtoxinA for the treatment of lower-limb spasticity in children and adolescents with cerebral palsy: A phase 3 study^1^ about?
## PURPOSE: Investigate the efficacy and safety of multipattern incobotulinumtoxinA injections in children/adolescents with lower-limb cerebral palsy (CP)-related spasticity. ## METHODS: Phase 3 double-blind study in children/adolescents (Gross Motor Function Classification System – Expanded and Revised I–V) with unilateral or bilateral spastic CP and Ashworth Scale (AS) plantar flexor (PF) scores ? 2 randomized (1:1:2) to incobotulinumtoxinA (4, 12, 16 U/kg, maximum 100, 300, 400 U, respectively) for two 12- to 36-week injection cycles. Two clinical patterns were treated. Pes equinus (bilateral or unilateral) was mandatory; if unilateral, treatment included flexed knee or adducted thigh. Endpoints: Primary: AS-PF change from baseline to 4 weeks; Coprimary: investigator-rated Global Impression of Change Scale (GICS)-PF at 4 weeks; Secondary: investigator’s, patient’s, and parent’s/caregiver’s GICS, Gross Motor Function Measure-66 (GMFM-66). ## RESULTS: Among 311 patients, AS-PF and AS scores in all treated clinical patterns improved from baseline to 4-weeks post-injection and cumulatively across injection cycles. GICS-PF and GICS scores confirmed global spasticity improvements. GMF
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- Author
- Florian Heinen; Petr Kanovský; A. Sebastian Schroeder; Henry G. Chambers; Edward Dabrowski; Thorin L. Geister; Angelika Hanschmann; Francisco J. Martinez-Torres; Irena Pulte; Marta Banach; Deborah Gaebler-Spira
- Publisher
- IOS Press
- Published
- 2021
- Language
- EN
- Field
- Medicine (Health Sciences)