A Compilation of Spasticity Studies Evaluating Onabotulinumtoxin A (P3.042)

OBJECTIVE: OnabotulinumtoxinA (BOTOX®, Allergan, Irvine CA USA) has been studied as treatment for adult and pediatric spasticity for over 20 years. BACKGROUND: To develop a comprehensive inventory of Allergan-sponsored spasticity studies examining onabotulinumtoxinA to provide guidance on future studies. DESIGN/METHODS: Spasticity studies meeting predetermined criteria were identified for data extraction using Allergan study databases. Studies were assessed according to 30 parameters, including but not limited to interventional vs. non-interventional design, duration, number of sites, patient type, spasticity presentation, treatment paradigm, and outcomes measures. RESULTS: This project yielded 47 Phase 1-4 studies (40 interventional, 7 non-interventional) performed between 1996-2013 and with 12-120 weeks duration. Interventional studies evaluated post-stroke or cerebral palsy patients. Most were double-blind-placebo-controlled (n=13), open label (n=12), or both (n=6). The largest study contained 58 sites. Thirty studies were conducted in US and/or Europe, 3 in Australia, 4 in Asia. The developmental interventional studies (n=36) contained over 5172 patients. Treatment data emerged for 39 unique muscles [(21 lower limb (LL), 18 upper limb (UL)]. Wrist, hand, and gastrocnemius muscles were most commonly treated. OnabotulinumtoxinA maximum doses were 400 U (fixed) and 6.3 U/kg (weight-based) in the UL and 360 U and 8 U/kg in LL. Patient follow-up approached 30 months. There were 73 physician-reported and 25 patient/caregiver-reported outcomes and all studies collected safety data. Non-interventional studies covered multiple etiologies related to upper motor neuron syndrome (e.g. stroke, MS), and were more recent (2009-2013). Most studies (n=6) were in US and/or Europe. The largest study had 127 sites. Seven physician-reported, 12 patient/caregiver-reported, and 28 utilization outcomes (e.g. patient/prescriber/disease characteristics) were measured. CONCLUSIONS: OnabotulinumtoxinA has been extensively studied for treatment of spasticity against a variety of rating scales/assessments and outcomes measures. Study Sponsored by: Allergan, Inc. Disclosure: Dr. Patel has received personal compensation for activities with Allergan Inc. Dr. Manack has received personal compensation for activities with Allergan Inc.