Phase 2 Stroke Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 to 70 years old (or 18 to 65 for the dose escalation part of the trial) at the time of signing the consent form
• People who have muscle stiffness and weakness on one side of the body (spastic hemiparesis) caused by a stroke or traumatic brain injury
• People who are at least 6 months past their stroke or brain injury
• People who have never had Botulinum toxin (BoNT) injections, or whose last BoNT injection was at least 4 months before the study start date
• People who have a muscle stiffness score of 2 or higher (on a standard medical scale called the Modified Ashworth Scale) in the specific muscle group being treated
• People whose arm muscles are eligible to receive the full recommended dose of the study drug (1000 units of Dysport) (confirm with trial site)
• People who have a measurable degree of stiffness (at least 5°) in the specific muscle group being treated
• People who do not have permanently locked or rigid joints — specifically, the fingers, wrist, and elbow must still be capable of a certain minimum range of movement
• People whose physiotherapy, occupational therapy, splinting, and any muscle relaxant or sedative medications have been stable and unchanged for at least 30 days before the study start date
• People who are in generally good health, with no uncontrolled ongoing illnesses or significant medical conditions, as assessed by the trial doctors
• Female participants who are not pregnant or breastfeeding, and who either cannot become pregnant or who agree to use an accepted form of contraception for the full duration of the study; women who could become pregnant must have a negative pregnancy test before joining
• Male participants who agree to use effective contraception during the study if their partner could become pregnant

Who may not be able to join:

• People with any medical condition — including severe swallowing difficulties or breathing problems — that the trial doctor believes could increase the risk of side effects from Botulinum toxin treatment
• People with a known disease affecting the connection between nerves and muscles, such as myasthenia gravis, Lambert-Eaton syndrome, or ALS (motor neurone disease)
• People with a known allergy or sensitivity to the study drug or any of its ingredients, or to other Botulinum toxin products
• People with a clinically diagnosed significant anxiety disorder or other significant mental health condition (such as depression) that might affect their ability to take part
• People who are likely to need any type of Botulinum toxin injection for any reason during the study
• People who have previously had surgery to treat spasticity in the affected arm
• People who have started physiotherapy within the 30 days before the study start date
• People who have previously had phenol or alcohol injections into the affected arm at any time
• People who have received or are likely to receive a medication called intrathecal baclofen within 30 days before the study start, or during the study
• People currently taking certain medications that affect how nerves and muscles communicate (such as certain antibiotics or muscle-blocking agents) within 30 days before the study start
• People taking other medications that the trial doctor believes would interfere with assessing the safety or effectiveness of the study treatment, including certain blood-thinning medicines (people on vitamin K antagonists may be considered if their blood levels are within a specific controlled range)
• People who have had or are planning tendon lengthening surgery, or who have significant joint stiffness or muscle wasting at the treatment site, in the 6 months before screening
• People who have used an experimental drug or medical device within a specified recent period before the study start, or who plan to do so during the study (confirm with trial site)
• People with any other condition, test result, or circumstance that, in the trial doctor's judgement, could increase risk or affect the quality of the study results — including other neuromuscular disorders, muscular dystrophies, or cancer-related muscle loss
• Women who are pregnant, breastfeeding, or who could become pregnant and are not willing to use a highly effective form of contraception for the full duration of the study
• People who are unable to understand the study procedures and requirements
• People with an infection at the planned injection site(s)
• People with a history of drug or alcohol misuse
• Male participants who have not had a vasectomy, whose female partner could become pregnant, and who are not willing to use condoms with spermicide throughout the study

Important: Always verify eligibility with the trial site directly before applying.