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Clinical Review Report: abobotulinumtoxinA (Dysport Therapeutic): (Ipsen Biopharmaceuticals Canada Inc.): Indication: For the symptomatic treatment of lower-limb spasticity in pediatric patients 2 years of age and older [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2018 Aug.

Cover of Clinical Review Report: abobotulinumtoxinA (Dysport Therapeutic)

Clinical Review Report: abobotulinumtoxinA (Dysport Therapeutic): (Ipsen Biopharmaceuticals Canada Inc.): Indication: For the symptomatic treatment of lower-limb spasticity in pediatric patients 2 years of age and older [Internet].

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Appendix 3Excluded Studies

ReferenceReason for Exclusion
Delgado MR, Bonikowski M, Carranza J, et al. Safety and Efficacy of Repeat Open-Label AbobotulinumtoxinA Treatment in Pediatric Cerebral Palsy. J Child Neurol. 2017;32(13):1058-1064.No comparator
Gracies JM, Esquenazi A, Brashear A, et al. Efficacy and safety of abobotulinumtoxinA in spastic lower limb: Randomized trial and extension. Neurology. 2017;89(22):2245-2253.Inappropriate population
Colovic H, Dimitrijevic L, Stankovic I, Nikolic D, Radovic-Janosevic D. Estimation of botulinum toxin type A efficacy on spasticity and functional outcome in children with spastic cerebral palsy. Biomedical Papers of the Medical Faculty of Palacky University in Olomouc, Czech Republic. 2012;156(1):41-47.No comparator
Kanovsky P, Bares M, Severa S, Richardson A, Dysport Paediatric Limb Spasticity Study G. Long-term efficacy and tolerability of 4-monthly versus yearly botulinum toxin type A treatment for lower-limb spasticity in children with cerebral palsy. Dev Med Child Neurol. 2009;51(6):436-445.Inappropriate comparator
Hu GC, Chuang YC, Liu JP, Chien KL, Chen YM, Chen YF. Botulinum toxin (Dysport) treatment of the spastic gastrocnemius muscle in children with cerebral palsy: a randomized trial comparing two injection volumes. Clin Rehabil. 2009;23(1):64-71.Inappropriate comparator
Pittock SJ, Moore AP, Hardiman O, et al. A double-blind randomised placebo-controlled evaluation of three doses of botulinum toxin type A (Dysport) in the treatment of spastic equinovarus deformity after stroke. Cerebrovasc Dis. 2003;15(4):289-300.Inappropriate population
Dursun N, Dursun E, Alican D. The role of botulinum toxin a in the management of lower limb spasticity in patients with cerebral palsy. Int J Clin Pract. 2002;56(8):564-567.Inappropriate dosage
Baker R, Jasinski M, Maciag-Tymecka I, et al. Botulinum toxin treatment of spasticity in diplegic cerebral palsy: a randomized, double-blind, placebo-controlled, dose-ranging study. Dev Med Child Neurol. 2002;44(10):666-675.Phase II non-pivotal trial
Polak F, Morton R, Ward C, Wallace WA, Doderlein L, Siebel A. Double-blind comparison study of two doses of botulinum toxin A injected into calf muscles in children with hemiplegic cerebral palsy. Dev Med Child Neurol. 2002;44(8):551-555.Inappropriate comparator
Pieper C. Botulinum toxin type a neuromuscular blockade in the treatment of lower extremity spasticity in cerebral palsy: a randomized, double-blind, placebo-controlled trial. Pediatr Phys Ther. 2001;13(2):92-94.Inappropriate dosage
Moore AP, Ade-Hall RA, Smith CT, et al. Two-year placebo-controlled trial of botulinum toxin A for leg spasticity in cerebral palsy. Neurology. 2008;71(2):122-128.Inappropriate dosage
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Bookshelf ID: NBK540249

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