Data from a large Phase II clinical trial sponsored by Allergan suggest that repeated treatment with Botox (botulinum toxin type A) improves muscle tone and functional disability in patients with spasticity of the upper limbs (the wrist, fingers and/or arm) following stroke. Additional data suggest these functional gains also have a positive impact on quality of life for post-stroke patients. Botox treatment was found to be well-tolerated, with treatment-related adverse events occurring in 6 percent of patients.
Approximately 700,000 Americans suffer a new or recurring stroke annually. Stroke is a leading cause of serious, long-term disability in the U.S. Since the 1970s, the number of stroke survivors has steadily increased.
Disabling spasticity, which causes muscles in the arms or legs to tighten uncontrollably, affects between 17 and 30 percent of stroke survivors and can lead to significant pain, discomfort and functional limitations. Almost 40 percent of patients who survive a stroke continue to have spasticity one year later. Upper limb spasticity is especially disruptive because it can interfere with patients' mobility, positioning, care, and comfort as well as their ability to dress, wash or feed themselves and perform other independent activities of daily living.