IncobotulinumtoxinA (Xeomin) for Upper Limb Spasticity

Prospective, Randomized, Observer-blind, Parallel-group, Multi-center Trial to Assess Efficacy and Safety of Two Different Dilutions of incobotulinumtoxinA (Xeomin) in Patients With Upper Limb Spasticity

This study will investigate the efficacy and safety of incobotulinumtoxinA (Xeomin) in the treatment of arm tightness (upper limb spasticity) using two different dilutions of incobotulinumtoxinA (Xeomin).

IncobotulinumtoxinA (Xeomin) is a botulinum toxin type A preparation free of complexing proteins. Injected into a muscle, incobotulinumtoxinA causes a reversible local weakening of the muscle for several months, and may improve an impaired muscle function by lessening the muscle tightness within few days. IncobotulinumtoxinA is widely used for various severe neurological conditions. There is some evidence that the treatment effect may be influenced by the amount of the solvent in which incobotulinumtoxinA is diluted before injection.

Main Inclusion Criteria:

• Female or male patients ≥ 18 years
• Stable upper limb spasticity of diverse etiology
• Focal spasticity with equal or more than 2 points on the Ashworth scale in the wrist flexors
• Disability Assessment Scale (DAS) ≥ 2 points for primary therapeutic target at both screening and baseline visits

Main Exclusion Criteria:

• Fixed contracture
• Bilateral upper limb paresis/paralysis
• Previous treatment with BoNT of any serotype and for any body region within the 4 months prior to screening
• Previous or planned treatment with phenol- or alcohol-injection in the target limb
• Other muscle hypertonia (e.g. rigidity)
• Diagnosis of myasthenia gravis, Lambert-Eaton-Syndrome, amyotrophic lateral sclerosis, or any other significant neuromuscular disease which might interfere with the study
• Severe atrophy of the target limb muscles