This study is looking at upper limb spasticity, which is a condition where muscles in the arm become stiff and tight, making it difficult to move the arm normally. This can happen due to various causes, including stroke. The study will compare two treatments called Dysport and Botox, which are both medicines that contain a substance called botulinum toxin type A. These medicines are given as injections directly into the affected muscles in the arm to help reduce the muscle stiffness and improve movement.
The purpose of this study is to show that Dysport is as safe as Botox when used to treat adults with upper limb spasticity by looking at side effects that occur during the first 12 weeks after the injection. Both medicines will be injected into specific muscles in the arm, including muscles that control the wrist, fingers, and elbow. The study will use a crossover design, which means that participants will receive both treatments at different times during the study, allowing doctors to compare how well each medicine works for the same person. The total amount of medicine given will be 900 units for Dysport or 360 units for Botox, depending on which treatment is being given at that time.
During the study, doctors will check for any unwanted effects or side effects that may occur after the injections. They will also measure how well the muscles respond to treatment by checking muscle stiffness, how well the arm functions in daily activities like dressing and hygiene, and whether there is any pain. These measurements will be taken at several visits over a period of up to 24 weeks. The study will also look at how long the treatment effects last before another injection is needed and will ask participants about their overall quality of life and how they feel about their treatment response.
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