This trial is examining the effectiveness and safety of Daxibotulinumtoxin A (DAXI) in the treatment of arm stiffness after a stroke. The main outcome to be measured is the change in muscle strength. This study is being conducted in California, Connecticut, Florida and Kansas, the US.
Patients who had a stroke often experience muscle spasticity. This condition involves the contraction of muscles, causing stiffness. Stiffness can affect normal movement and daily activities. It affects the quality of life of patients.
DaxibotulinumtoxinA is a form of Botox injection. This study evaluates its safety and effectiveness to treat arm stiffness after a stroke. The main outcome will be evaluated by measuring the change in muscle strength and movement. The side effects related to the treatment will also be measured.
Who are they looking for?
128 patients will be recruited. Patients should have moderate to severe disability and must be able to communicate.
Patients should not have started physical therapy 30 days or less prior to the start of this trial. Patients should not have had treatment with phenol, alcohol injection, surgery or baclofen into the spine. Patients should not have any other brain condition or stiffness in both arms.
How will it work
Patients will be randomly assigned to receive one of four treatments. 3 groups will receive DAXI by injection. The treatment groups are DAXI high dose, DAXI medium dose, DAXI low dose. One group will receive a placebo.
The study consists of a 21-day screening period, a treatment visit and follow-up visits for up to 2 years.