Medicine and Health Sciences Commons^™

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 …

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 …