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Abstract Details

Multi-level and Multi-pattern Lower- and Upper-limb Spasticity Treatment with IncobotulinumtoxinA in Children and Adolescents with Cerebral Palsy
Child Neurology and Developmental Neurology
P5 - Poster Session 5 (8:00 AM-9:00 AM)
5-013
Assess efficacy and safety of incobotulinumtoxinA in lower-limb (LL) or combined LL/upper-limb (LL/UL) spasticity in children and adolescents with cerebral palsy (CP).
Spasticity is the most prominent movement disorder in children with CP. 
Two phase III studies; a lead-in prospective, double-blind, randomized study (TIM) followed by an open-label, non-controlled study (TIMO). TIM had three parallel dose groups (4 U/kg body weight (BW), 12 U/kg BW, 16 U/kg BW); subjects were randomized in a 1:1:2 ratio and received 2 double-blind injection cycles. In TIMO, subjects who had completed TIM, or newly recruited treatment-naïve or pre-treated subjects, received 4 injection cycles with the highest dose of TIM.  The primary endpoints of TIM were change from baseline in Ashworth Scale (AS) of the plantar flexors (PF) score at Week 4 of Cycle 1, and the Investigator’s Global Impression of Change of Plantar Flexor Spasticity Scale (GICS-PF) score at Week 4 of Cycle 1. TIMO was focused on safety, and did not have primary efficacy endpoints. 
In TIM, all 3 dose groups experienced a statistically significant improvement in AS-PF score 4 weeks post-injection versus baseline. In TIMO, cumulative improvements in AS scores for the PF, knee flexors and thigh adductors were observed from TIM baseline to 4 weeks post-injection. Investigator’s GICS-PF scores indicated a positive response to treatment in all dose groups 4 weeks post-injection in TIM Cycle 1 and improvements were maintained in all treatment groups in Cycle 2. Respective clinical assessments also confirmed consistent improvement in LL and UL spasticity at Week 4 in all TIMO injection cycles. Both studies had good overall safety profiles.
IncobotulinumtoxinA at total doses up to 16–20 U/kg is effective and well tolerated for the multi-level, multi-pattern treatment of LL/UL spasticity due to CP in children and adolescents.
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
Petr Kanovsky, PhD Dr. Kanovsky has nothing to disclose.
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.
No disclosure on file
No disclosure on file
Francisco Martinez-Torres, MD, PhD (Dompé U.S. Inc.) No disclosure on file
Irena Pulte Irena Pulte has received personal compensation for serving as an employee of Merz Pharmaceuticals . Irena Pulte has received intellectual property interests from a discovery or technology relating to health care.
No disclosure on file