Effects on Quality of Life Following Dysport Treatment in Post-stroke Spasticity of the Arm

A Prospective Phase IV, Multicentre, Placebo-controlled Study to Demonstrate Changes in the Quality of Life Following DYSPORT Intramuscular Injection in the Treatment of Upper Limb Spasticity in Adult Post-Stroke Patients

The main purpose of this study is to assess the effect on Quality of Life of two cycles of Dysport treatment on post-stroke spasticity of the upper limb. The effect of treatment on spasticity and function will also be measured.

Inclusion Criteria:

• The patient has suffered a stroke, as defined by the World Health Organisation (WHO) criteria, at least 6 months previously.
• The patient has a hemiparetic arm and meets minimum score requirements on the Modified Ashworth Scale.
• The patient has the cognitive and communication ability to participate in the study.

Exclusion Criteria:

• Patients who have received botulinum toxin treatment within the past 120 days.
• Contraindication to botulinum toxin treatment.
• Patients who are receiving oral anti-spasticity medication and who have had a change in dosage of this medication in the month prior to study entry.
• Patients who have previously been treated with phenol for their upper limb spasticity.