Abstract Details

Title Efficacy and Safety of IncobotulinumtoxinA for Upper- or Combined Upper- and Lower-Limb Spasticity in Children and Adolescents with Cerebral Palsy: Results of the Phase 3 XARA Study

Topic Movement Disorders

Presentation(s) Movement Disorders Posters (7:00 AM-5:00 PM)

Poster/Presentation
Number 133

Objective To assess the efficacy and safety of incobotulinumtoxinA for upper- and combined upper- and lower-limb spasticity in ambulant and non-ambulant children and adolescents with cerebral palsy (CP).

Background IncobotulinumtoxinA is a purified botulinum toxin type A formulation, free from complexing proteins.

Design/Methods XARA (NCT02002884) was a randomized, Phase 3 study with a double-blind main period (MP) and open-label extension (OLEX) period. Patients aged 2–17 years with uni- or bilateral CP and Ashworth Scale (AS) score ≥2 in main clinical target patterns, flexed elbow and/or wrist, were enrolled. In MP, patients were randomized (2:1:1) to three incobotulinumtoxinA dose groups (8, 6, 2 U/kg body weight [BW]; maximum 200, 150, 50 U/upper limb) with additional lower limb injections (total body dose ≤16–20 U/kg BW [≤400–500 U], depending on Gross Motor Function Classification System level [GMFCS]). Patients received three further injection cycles (ICs) in OLEX, with doses per the 8 U/kg BW group. Outcomes included AS, Global Impression of Change Scale (GICS), and adverse events (AEs).

Results 350 patients (62.9% male, mean [SD] age 7.3 [4.4] years, BW 25.0 [15.0] kg, 30.9% GMFCS IV–V) were treated; 281 (80.3%) completed the study, receiving four incobotulinumtoxinA ICs. In MP, AS scores for upper limb main clinical pattern improved significantly from baseline to Week 4 (p<0.0001), with significantly greater improvement in the 8 U/kg versus the 2 U/kg dose group (p=0.017). Improvements were observed in all treated upper- and lower-limb clinical patterns and across all OLEX ICs. GICS scores confirmed global improvements in upper- and lower-limb spasticity but did not differ between dose groups. There was no increased incidence of AEs with increasing dose or repeated treatment.

Conclusions This large pediatric study confirmed the efficacy and safety of incobotulinumtoxinA for muscle tone reduction in multi-level, multi-pattern treatment of spasticity in patients with CP (GMFCS I–V).

Authors/Disclosures
Edward R. Dabrowski, MD PRESENTER	Dr. Dabrowski has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merz. Dr. Dabrowski has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Ipsen. Dr. Dabrowski has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Solstice. Dr. Dabrowski has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alergan. Dr. Dabrowski has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Ipsen. Dr. Dabrowski has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merz. Dr. Dabrowski has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Ipsen. Dr. Dabrowski has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Allergan. Dr. Dabrowski has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Solstice. Dr. Dabrowski has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Alergan. The institution of Dr. Dabrowski has received research support from Ipsen. The institution of Dr. Dabrowski has received research support from Merz.
	No disclosure on file
	No disclosure on file
Marta Banach, MD	Dr. Banach has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merz Pharmaceuticals GmbH. Dr. Banach has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merz Pharmaceuticals GmbH. Dr. Banach has received personal compensation in the range of $500-$4,999 for serving as a Speaker with Merz Pharmaceuticals GmbH.
Petr Kanovsky, PhD	Dr. Kanovsky has nothing to disclose.
	No disclosure on file
Michael Althaus (Merz Pharmaceuticals GmbH)	Michael Althaus has received personal compensation for serving as an employee of Merz Pharmaceuticals.
	No disclosure on file
	No disclosure on file

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Abstract Details