title: Rationale and design of a multicentre, double-blind, prospective, randomized, European and Canadian study: evaluating patient outcomes and costs of managing adults with post-stroke focal spasticity.
abstract: OBJECTIVE
  This report describes the design of a study aiming to provide evidence for the extended use of botulinum toxin A in focal post-stroke upper and lower limb spasticity and to evaluate the impact of incorporating botulinum toxin treatment into the rehabilitation of patients with spasticity.
  
  
  METHODS
  International, prospective, randomized, double-blind, placebo-controlled study with an open-label extension.
  
  
  METHODS
  Approximately 300 adults with a stroke occurring ≥ 3 months before screening, presenting with symptoms and signs of an upper motor neuron syndrome and focal spasticity-related functional impairment, were randomized to botulinum toxin (BOTOX®, Allergan Inc.) + standard care or placebo + standard care. Study medication was administered at baseline and again at Week 12 if required, with follow-up to 52 weeks. The primary endpoint was the number of patients who achieved their investigator-rated principal active functional goal (as measured by Goal Attainment Scaling), at 10 weeks after the second injection (Weeks 22-34) or at the 24-week visit if no second injection was administered. Secondary endpoints included changes from baseline in level of goal achievement, health-related quality of life and resource utilization.
  
  
  CONCLUSIONS
  Botulinum toxin A Economic Spasticity Trial (BEST) will provide information regarding clinical and cost-effectiveness of botulinum toxin + standard care vs standard care alone in patients with upper and/or lower limb post-stroke spasticity typically seen in clinical practice.
  
  
  BACKGROUND
  ClinicalTrials.gov number NCT-00549783.
authors.affiliation: Department of Clinical Sciences, Karolinska Institutet, Rehabilitation Medicine, Danderyd Hospital, Stockholm, Sweden. Jorgen.Borg@ki.se
authors.forename: Jörgen
authors.initials: J
authors.lastname: Borg
authors.forename: Anthony B
authors.initials: AB
authors.lastname: Ward
authors.forename: Jörg
authors.initials: J
authors.lastname: Wissel
authors.forename: Jai
authors.initials: J
authors.lastname: Kulkarni
authors.forename: Mohamed
authors.initials: M
authors.lastname: Sakel
authors.forename: Per
authors.initials: P
authors.lastname: Ertzgaard
authors.forename: Per
authors.initials: P
authors.lastname: Åkerlund
authors.forename: Iris
authors.initials: I
authors.lastname: Reuter
authors.forename: Christoph
authors.initials: C
authors.lastname: Herrmann
authors.forename: Lalith
authors.initials: L
authors.lastname: Satkunam
authors.forename: Theodore
authors.initials: T
authors.lastname: Wein
authors.forename: Isabelle
authors.initials: I
authors.lastname: Girod
authors.forename: Nicola
authors.initials: N
authors.lastname: Wright
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019274:Botulinum Toxins, Type A / Q000191:economics / Q000627:therapeutic use; D002170:Canada; D003362:Cost-Benefit Analysis; D004311:Double-Blind Method; D005060:Europe; D005260:Female; D005500:Follow-Up Studies; D006040:Goals; D006801:Humans; D008297:Male; D008875:Middle Aged; D009128:Muscle Spasticity / Q000188:drug therapy / Q000209:etiology / Q000534:rehabilitation*; D009465:Neuromuscular Agents / Q000191:economics / Q000627:therapeutic use; D017063:Outcome Assessment, Health Care; D011446:Prospective Studies; D020521:Stroke / Q000150:complications / Q000188:drug therapy; D000071939:Stroke Rehabilitation; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A