Abstract Details

Title Reduction of Upper Limb Spasticity Following AbobotulinumtoxinA Injections in Children with Cerebral Palsy: Results from an International, Phase 3, Pivotal Study

Topic Child Neurology and Developmental Neurology

Presentation(s) P5 - Poster Session 5 (8:00 AM-9:00 AM)

Poster/Presentation
Number 5-012

Objective Assess the reduction in upper-limb spasticity following abobotulinumtoxinA injections for spasticity in children with cerebral palsy (CP).

Background Previous studies of botulinum toxin for upper-limb spasticity have been small, and few have evaluated repeat treatment.

Design/Methods This was a double-blind, repeat-treatment (≤4 cycles over 1 year) study (NCT02106351). Children (2-17y) with CPandspasticity in ≥1 upper-limb were randomized (1:1:1) to Cycle-1 injections of abobotulinumtoxinA 8U/kg, 16U/kg or 2U/kg (control) into the primary target muscle group (PTMG; elbow or wrist flexors). The PTMG could change in cycles 2-4, when children received 8U/kg or 16U/kg.

Results 212 children were randomized and 180 completed the study. Changes in the Modified Ashworth Scale (MAS) of the PTMG from Baseline to Week-6 of Cycle 1 (primary-endpoint) were significantly different for the 8U/kg and 16U/kg abobotulinumtoxinA groups versus 2U/kg control (mean reductions from baseline of -2.0 and -2.3 vs. -1.6, respectively), and statistical difference was maintained at Week-16. All three groups showed improvement in Tardieu Scale parameters in the PTMG. For PTMG elbow flexors, significant (p≤0.05) improvements for both study dose groups versus the control group were seen at Week-6 for the angle of catch (X_V3) and spasticity angle (X). For PTMG wrist flexors, the 16U/kg dose (but not the 8U/kg dose) was significantly superior (p<0.001) to the control 2U/kg dose at Week-6 in Tardieu Scale X_V3 and X. Benefits were sustained over the 1-year study with repeat abobotulinumtoxinA injections (8U/kg or 16U/kg). Mean injection intervals (2U/kg, 8U/kg, 16U/kg) were: 22.4, 23.9 and 25.6 weeks, respectively. Muscular weakness was the only treatment-related AE in ≥1 child/group (4.3%, 5.7% vs. 1.4%, respectively).

Conclusions AbobotulinumtoxinA administered at doses of 8U/kg or 16U/kg in the upper-limb significantly reduced spasticity compared to the 2U/kg control dose and was well-tolerated. Therapeutic benefits were sustained with repeat injections of 8U/kg or 16U/kg over one year.

Authors/Disclosures
Ann H. Tilton, MD, FAAN (LSUHSC and Childrens Hospital of New Orleans) PRESENTER	Dr. Tilton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Ipsen. Dr. Tilton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Tilton 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. Tilton has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie. Dr. Tilton has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Ipsen. Dr. Tilton has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Abbvie. Dr. Tilton has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Up to Date.
Jorge Carranza, MD	Dr. Carranza has received personal compensation in the range of $500-$4,999 for serving as a Consultant for IPSEN. Dr. Carranza has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for IPSEN.
	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
Edward R. Dabrowski, MD	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.
Anne-Sophie Grandoulier	No disclosure on file
Philippe Picaut	No disclosure on file
Mauricio R. Delgado, MD, FRCPC, FAAN	Dr. Delgado has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Ipsen. Dr. Delgado has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Allergan. Dr. Delgado has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kashiv. The institution of Dr. Delgado has received research support from Ipsen.

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