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Improvements In Lower Limb Spasticity-Related Pain In Children/Adolescents With Cerebral Palsy After Incobotulinumtoxina Injections, Florian Heinen, Michaela Bonfert, Petr Kanovsky, A Sebastian Schroeder, Henry Chambers, Edward Dabrowski, Thorin Geister, Angelika Hanschmann, Michael Althaus, Marta Banach, Deborah Gaebler-Spira

Conference Presentation Abstracts

Introduction: The effects of incobotulinumtoxinA on lower limb (LL) spasticity-related pain (SRP) over multiple treatment cycles (ICs) in children/adolescents (C/As) with cerebral palsy (CP) were analyzed using pooled data from three prospective phase 3 trials.

Patients and methods: C/As aged 2–17 years with CP-associated LL spasticity received incobotulinumtoxinA for 4 ICs. SRP was assessed with the Questionnaire on Pain caused by Spasticity (QPS) using C/A- (direct or via interviewer) and parent/caregiver (P/C)-completed LL modules. The pain population included all C/As with a key QPS item score >0 at baseline; post-baseline scores of 0 indicated complete pain relief.

Results: Data from …

Improvements In Upper Limb Spasticity-Related Pain In Children/Adolescents With Cerebral Palsy After Incobotulinumtoxina Injections, Florian Heinen, Michaela Bonfert, Petr Kanovsky, A Sebastian Schroeder, Henry Chambers, Edward Dabrowski, Thorin Geister, Angelika Hanschmann, Michael Althaus, Marta Banach, Deborah Gaebler-Spira

Conference Presentation Abstracts

Introduction: The effects of incobotulinumtoxinA on upper limb (UL) spasticity-related pain (SRP) over multiple treatment cycles (ICs) in children/adolescents (C/As) with cerebral palsy (CP) were analyzed using pooled data from two prospective phase 3 trials.

Patients and methods: C/As aged 2–17 years with CP-associated UL spasticity received incobotulinumtoxinA for 4 ICs. SRP was assessed with the Questionnaire on Pain caused by Spasticity (QPS) using C/A- (direct or via interviewer) and parent/caregiver (P/C)-completed UL modules. The pain population included all C/As with a key QPS item score >0 at baseline; post-baseline scores of 0 indicated complete pain relief.

Results: Data from …

Prevalence Of Spasticity-Related Pain In Children/Adolescents With Cerebral Palsy, Florian Heinen, Michaela Bonfert, Petr Kanovsky, A Sebastian Schroeder, Henry Chambers, Edward Dabrowski, Thorin Geister, Angelika Hanschmann, Michael Althaus, Marta Banach, Deborah Gaebler-Spira

Conference Presentation Abstracts

Introduction: This analysis determined the prevalence and intensity of spasticity-related pain (SRP) in children/adolescents (C/As) with cerebral palsy (CP).

Patients and methods: Baseline data from the prospective incobotulinumtoxinA trials TIM, TIMO and XARA were pooled. In all three studies, SRP was assessed in C/As aged 2–17 years with lower limb (LL) and/or upper limb (UL) spasticity using the Questionnaire on Pain caused by Spasticity (QPS); both self-reports (direct or via interviewer) and parent/caregiver (P/C) observer reports were included. A C/A was considered to have SRP if any QPS key item score was rated >0 at baseline. Individual QPS modules were …

Absence Of Neutralizing Antibody Formation During Incobotulinumtoxina Treatement Of Spasticity In Botulinum Toxin-Naive Children With Cerebral Palsy: Pooled Analysis Of Three Phase 3 Studies, Henry Chambers, Petr Kanovsky, A Sebastian Schroeder, Edward Dabrowski, Thorin Geister, Angelika Hanschmann, Irena Pulte, Michael Althaus, Marta Banach, Deborah Gaebler-Spira, Florian Heinen

Conference Presentation Abstracts

Introduction: The development of neutralizing antibodies (NAbs) has been linked to secondary non-response to botulinum neurotoxin type A (BoNT-A) injections. This may be of special concern when treating conditions like pediatric spasticity. We investigated NAb formation in three large Phase 3 studies with incobotulinumtoxinA, a BoNT-A lacking complexing proteins, in children/adolescents with cerebral palsy (CP).

Patients and methods: Patients with lower-limb (LL), upper-limb (UL), or combined LL/UL spasticity (2–17 years; uni- or bilateral CP; Ashworth Scale score ≥2 in clinical patterns for treatment) received total body weight incobotulinumtoxinA ≤16–20 U/kg (max. 400–500 U) depending on the study (TIM: NCT01893411; TIMO: …

Safety Of Incobotulinumtoxina In Multipattern Treatment Of Upper And Lower Limb Spasticity In Children/Adolescents With Cerebral Palsy: Pooled Analysis Of 3 Large Phase 3 Studies, Marta Banach, Petr Kanovsky, A Sebastian Schroeder, Henry G. Chambers, Edward Dabrowski, Thorin L. Geister, Hanna Dersch, Michael Althaus, Deborah Gaebler-Spriag, Florian Heinen

Conference Presentation Abstracts

Introduction: This analysis assessed the safety and tolerability of repeated incobotulinumtoxinA treatment for lower-limb (LL), upper-limb (UL), or combined LL/UL spasticity in ambulant and non-ambulant children/adolescents with cerebral palsy (CP) using pooled data from 3 large Phase 3 studies.

Methods: Pediatric patients with spasticity (2–17 years of age; uni- or bilateral CP; Gross Motor Function Classification System [GMFCS] level I-V; Ashworth Scale [AS] score ≥2 in clinical patterns for treatment; clinical need for treatment) were enrolled. Patients received total body incobotulinumtoxinA doses of 16 U/kg body weight (BW, ≤400 U) for LL spasticity in 2 injection cycles (ICs) in TIM …

Improvement Of Spasticity-Related Pain With Incobotulinumtoxina Treatment In Children/Adolescents With Cerebral Palsy: Pooled Analysis Of 3 Phase 3 Studies, Florian Heinen, Petr Kanovsky, A Sebastian Schroeder, Henry G. Chambers, Edward Dabrowski, Thorin L. Geister, Hanna Dersch, Irena Pulte, Michael Althaus, Marta Banach, Deborah Gaebler-Spirag

Conference Presentation Abstracts

Introduction: Spasticity-related pain (SRP) in children and adolescents with cerebral palsy (CP) is common, often neglected, and impacts daily quality of life. We assessed the effect of incobotulinumtoxinA on SRP using pooled data from 3 large Phase 3 pediatric studies.

Methods: Ambulant and non-ambulant patients (2–17 years of age; uni- or bilateral CP; Ashworth Scale score ≥2 in clinical patterns for treatment) were enrolled. Patients received total body incobotulinumtoxinA doses of ≤16 U/kg (≤400 U) for lower-limb (LL) treatment in 2 injection cycles (ICs) in TIM (NCT01893411). In TIMO (NCT01905683), TIM completers and new recruits received 4 ICs with 16–20 …

Pooled Efficacy Analysis Of Incobotulinumtoxina In The Multipattern Treatment Of Upper- And Lower-Limb Spasticity In Children And Adolescents With Cerebral Palsy, Florian Heinen, Petr Kanovsky, A Sebastitan Schroeder, Henry G. Chambers, Edward Dabrowski, Thorin L. Geister, Hanna Dersch, Irena Pulte, Michael Althaus, Marta Banach, Deborah Gaebler-Spirag

Conference Presentation Abstracts

Introduction: This pooled analysis assessed the efficacy of incobotulinumtoxinA for lower-limb (LL) and upper-limb (UL) spasticity in children and adolescents with cerebral palsy (CP) using data from the first controlled injection cycle of 2 large Phase 3 studies, TIM (NCT01893411) and XARA (NCT02002884).

Methods: Ambulant and non-ambulant pediatric patients with spasticity due to CP (2–17 years of age; uni- or bilateral CP; Ashworth Scale [AS] score ≥2 in clinical patterns for treatment) were enrolled. Patients were randomized (2:1:1) to 3 incobotulinumtoxinA dose groups: 8, 6, 2 U/kg body weight (BW), maximum 200, 150, 50 U per LL clinical pattern in …