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:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-24 @ 7:11 PM
NCT ID:
NCT05164003
Eligibility Criteria:
Inclusion Criteria:
* Male or female patients ≥ 19 years
* 6 months since the last stroke
* 2 points in the focal spasticity of wrist flexor and ≥ 1 point at least one of elbow flexor and finger flexor as measured on MAS(0 to 4)
* Informed consent has been obtained
Exclusion Criteria:
* Neuromuscular disorders such as Lambert-Eaton syndrome, myasthenia gravis, or amyotrophic lateral sclerosis
* History(within 4 months of screening visit) or planned(during study period) treatment with phenol or alcohol injection 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
* Fixed joint/muscle contracture
* Severe atrophy
* Concurrent treatment with an intrathecal baclofen
* Patients who have bleeding tendency or taking anti-coagulant
* Dysphagia and Breathing Difficulties
* History(within 4 months of screening visit) Planned(during study period) treatment with Botulinum Toxin
* Known allergy or sensitivity to study medication or its components
* Concurrent or planed Muscle relaxants and/or benzodiazepine medication If patient has taken these medication stable from one month before screening and no treatment changes are not planned during the study, participation is allowed.
* Current Physical, occupational, Splinting therapy These therapy regimens will be permitted if they have been stable in the one month before screening; no treatment and no changes are planned during the study.
* Patient who are participating in other clinical trials at the screening
* Females who are pregnant, breastfeeding, or planning a pregnancy during the study period, or female of childbearing potential, not using a reliable means of contraception.
* Patients who are not eligible for this study at the discretion of the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT05164003
Study Brief:
Protocol Section:
NCT05164003