Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT05382767
Eligibility Criteria:
Inclusion Criteria:
* Male or female patients ≥ 19 years
* History of stroke more than 24 weeks prior to screening
* ≥ 2 points in the focal spasticity of wrist flexor and ≥ 1 point at least one of finger flexor and elbow flexor as measured on MAS(0 to 4)
* ≥ 2 points in one of the targeted functional disability item (i.e. hand hygiene, clothing, upper extremity, or pain for evaluation on DAS
Exclusion Criteria:
* Neuromuscular disorders such as Lambert-Eaton syndrome, myasthenia gravis, or amyotrophic lateral sclerosis
* Fixed joint/muscle contracture in the target limb
* History(within 24 weeks of screening visit) or planned(during study period) treatment with phenol or alcohol injection(chemodenervation) or surgery in the target limb
* History(within 4 months of screening visit) or planned(during study period) treatment with tendon lengthening in the target limb
* History(within 12 weeks of screening visit) treatment with Botulinum Toxin
* Concurrent treatment with an intrathecal baclofen
* Known allergy or sensitivity to the study medication or its components (Clostridium botulinum toxin type A, albumin, Sodium chloride, etc.)
* Male and Female who are not willing to take any appropriate means of contraception during the study period
* Patients who are not eligible for this study at the discretion of the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT05382767
Study Brief:
Protocol Section:
NCT05382767