Category: Functioning and Disability
In two phase III studies; a lead-in prospective, double-blind, randomized study (TIM) followed by an open-label, non-controlled study (TIMO), we 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).
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.
Edward Dabrowski– Director, Beaumont Health, Oakland University School of Medicine
Henry Chambers– Orthopaedic Surgeon, Rady Children's Hospital-San Diego
Florian Heinen– Department of Pediatric Neurology and Developmental Medicine, Ludwig University of Munich Maximilian
Petr Kanovsky– Head , Department of Neurology, Vice-Dean for Research and Science, Palacky University Olomouc
A. Sebastian Schroeder– Department of Pediatric Neurology and Developmental Medicine, Ludwig University of Munich Maximilian
Kerr Graham– Department of Orthopedics, Royal Children's Hospital
Marta Banach– Associate Professor and Head of the Department of Clinical Neurophysiology, Jagiellonian University Medical College
Hanna Dersch– Biostatistician, Merz Pharmaceuticals GmbH
Thorin Geister– Lead Scientific Expert Evidence-Based Medicine, Merz Pharmaceuticals GmbH
Francisco Martinez-Torres– Former employee, Merz North America
Irena Pulte– Head of Global Clinical Science Therapeutics, Merz Pharmaceuticals GmBH
Deborah Gaebler-Spira– Professor of Pediatrics and Physical Medicine and Rehabilitation, Northwestern, Shirley Ryan AbilityLab