None listed
Conditions
Interventions
Drug : The investigational medicinal product will be administered as a single intramuscular injection to subjects who meet all inclusion and exclusion criteria. The injection site will be selected bas
the degree of spasticity
the presence of localized muscle weakness
and the subject’s response to previous treatments. An appropriately sized needle will be used depending on muscle depth (surface muscles: 24–30 gauge
deeper muscle tissue: 22 gauge). The maximum allowable total dose for each subject is 360 Units.
The above administration method will be applied equally to both the treatment group and the control gr
Sponsors
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Individuals who voluntarily decide to participate in this clinical trial and provide written informed consent (either the subject or the subject’s legally authorized representative). 2) Adults aged 19 years or older. 3) Subjects who have been diagnosed with stroke at least 6 weeks prior to the screening visit. 4) Subjects with focal muscle spasticity of the wrist flexors with a MAS (Modified Ashworth Scale) score of =2 and spasticity with a MAS score of =1 in at least one of the following muscles: elbow flexors or finger flexors. 5) Subjects who have a score of =2 in one target domain selected for treatment (hygiene, dressing, limb position, or pain) on the Disability Assessment Scale (DAS). 6) Female subjects must be non–childbearing potential*, or if of childbearing potential, must not be pregnant or breastfeeding, must have a negative pregnancy test at screening, and must agree to practice abstinence or use medically acceptable contraception** during the clinical trial period. Male subjects must also agree to use medically acceptable contraception during the clinical trial period. * Women of childbearing potential (WOCBP): Women who have experienced menarche and have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), and who are not postmenopausal, defined as 12 consecutive months of amenorrhea without an alternative medical cause. ** Medically acceptable methods of contraception include hormonal contraceptives (implant, injection, oral contraceptives, etc.), intrauterine devices (copper IUD or hormone-releasing IUS), double-barrier methods [male condom plus a female barrier device (diaphragm, sponge, or cervical cap)], and surgical sterilization (vasectomy or tubal ligation).
Exclusion criteria
Exclusion criteria: 1) Individuals with neuromuscular junction disorders that may affect neuromuscular function (e.g., myasthenia gravis, Lambert–Eaton syndrome, amyotrophic lateral sclerosis). 2) Individuals with dysphagia of sufficient severity, as determined by the investigator, that may interfere with participation in the clinical trial. 3) Individuals with evidence of fixed joints or muscle contracture* at the intended injection sites for the investigational medicinal product. *Defined as a condition in which severe resistance to passive stretching significantly limits the range of motion of the joint or muscle. 4) Individuals with severe muscle atrophy at the intended injection sites for the investigational medicinal product. 5) Individuals with infection, dermatologic conditions, scars, or other skin abnormalities at the intended injection sites for the investigational medicinal product. 6) Individuals with a history of acute deterioration of pulmonary function within 3 months prior to screening (e.g., hospitalization due to exacerbation of asthma or chronic obstructive pulmonary disease [COPD], or pneumonia). 7) Individuals who have undergone phenol or alcohol chemodenervation or any surgery at the intended injection sites within 24 weeks prior to screening, or who are expected to require such treatments or surgery during the clinical trial. 8) Individuals who have undergone tendon-lengthening procedures at the intended injection sites within 24 weeks prior to screening, or who are expected to require such surgery during the clinical trial. 9) Individuals who have received botulinum toxin treatment within 24 weeks prior to screening. 10) Individuals receiving intrathecal baclofen therapy. 11) Individuals who require administration of prohibited concomitant medications or prohibited concomitant treatments specified in the clinical trial protocol during the clinical trial period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Event;physical examination;laboratory test;Vital Signs;Change in MAS scores for Wrist Flexor at each visit (Visit 3, 4, 5) compared to the baseline.;Change in MAS scores for Elbow Flexor and Finger Flexor at each visit (Visit 3, 4, 5) compared to the baseline.;The proportion of participants with a reduction of 1 point or more in MAS at Wrist Flexor, Elbow Flexor, and Finger Flexor at each visit (Visit 3, 4, 5) compared to the baseline.;Change in scores of the DAS target treatment items at each visit (Visit 3, 4, 5) compared to the baseline.;Change in overall improvement (GAS) assessed by the investigator at each visit (Visit 3, 4, 5) after administration of the investigational drug.;Change in overall improvement (GAS) assessed by the participant at each visit (Visit 3, 4, 5) after administration of the investigational drug.;Change in CBS scores assessed by the caregiver at each visit (Visit 3, 4, 5) compared to the baseline. | — |
Countries
Korea, Republic of
Contacts
Public ContactShiuk Lee
Seoul National University
Outcome results
None listed