None listed
Conditions
Interventions
Biological/Vaccine, Non-Stem Cell : At baseline, Botulax or Botox is injected intramuscularly in the target muscle/s at a maximum dose of 360U
Sponsors
Hugel
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects no younger than 20 years of age. 2. Patients diagnosed with stroke =6 weeks prior to enrollment in current study 3. Focal spasticity score = 2 points at wrist flexor and = 1 point at one or more of the following muscles: elbow flexor and/or finger flexor (scores measured on the MAS (0 to 4)) 4. A minimum of grade 2 in the targeted functional disability item (i.e., hygiene, dressing, upper-limb position sense, or pain) on the Disability Assessment Scale (0 to 3) 5. Voluntary informed consent signed by patient or patient’s legal guardian after objective, methods, and efficacy of clinical study have been explained
Exclusion criteria
Exclusion criteria: 1. Subjects who have a history of Neuromuscular Junction Disorders (Ex,Myasthenia Graris,Lambert-Eaton myasthenic syndrome, Congenital myasthenic syndrome) 2. Patients with significant atrophy of the muscle in the target limb 3. Patients with fixed joint/muscle contracture* in the target limb * Defined as inability to passively move the joints 4. Prior (within 6 months of administration of study drug) or planned (during study period) treatment with phenol/alcohol injection (chemodenervation) in the target limb 5. Prior (within 6 months of administration of study drug) or planned (during study period) tendon lengthening surgery in the target limb
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of Modified Ashworth Scale (MAS) scores of wrist flexor evaluated by the investigator in weeks 4 from the Investigatioal Product injection | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement of Modified Ashworth Scale (MAS) scores of elbow flexor, finger flexor, thumb flexor evaluated by the investigator in weeks 4 from the Investigatioal Product injection;Improvement of Modified Ashworth Scale (MAS) scores of wrist flexor, elbow flexor, finger flexor, thumb flexor evaluated by the investigator in weeks 8,12 from the Investigatioal Product injection;Laboratory Tests;Vital Signs (Blood pressure, pulse and temperature) | — |
Countries
Korea, Republic of
Contacts
Public ContactHyunju Shin
Hugel
Outcome results
None listed