Upper Limb Spasticity
ADULTS WITH UPPER LIMB SPASTICITY
ISPEN CLIN-52120-452-A multi-centre, interventional, post marketing, randomized, double-blind, crossover study to evaluate the clinical safety and efficacy of abobotulinumtoxinA (Dysport) in comparison with oabotulinumtoxin A (Botox) when treating adults with upper limp spasticity.
- PI: CHRISTOPHER VACHON
- CONTACT MINDY
- Duration 1 year study.
KEY INCLUSION CRITERIA
- Ages 18 to 75 years of age.
- Subjects with stable ULS for at least 3 months, in whom treatment of only one upper limb is necessary for the duration of the study.
- Subjects who are either naïve to BoNTA for ULS or who have been previously treated with BoNT-A for ULS.
- Participants with MAS score of at least 2 at elbow, wrist and finger flexors
- Participants with DAS score of at least 2 on the PTT (one of four functional domains: dressing, hygiene, limb position and pain)
- Participants who require BoNT-A injection in all of the following muscles: flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis and biceps brachii
- Participants for whom injection of a total dose of 900 U aboBoNT-A or 360 U onaBoNT-A in considered by the PI to be clinically appropriate.
- Participants who have been stable for at least 3 months prior to study entry in terms of oral antispasticity, anticoagulant and/or anticholinergic medication, if treated, and for at least 1 month prior to study entry in terms of occupation therapy and/or physiotherapy treatment, if treated, and are considered by the PI likely to remain stable for the duration of the study.