Spasticity as Sequela of Stroke
Conditions
Brief summary
Study Design: Randomized Single Blind Study Objective: To determine the dose relationship of DWP 450 for finger flexor spasticity Subjects: 78 patients with upper extremity spasticity after CVA Inclusion criteria: Patient who have spasticity (MAS greater than 2 in finger flexors) Methods: Patients will be randomly assigned to one of 5 groups. Gp 1: placebo, Gp 2: 15U, Gp 3: 30 U, Gp 4: 50 U, Gp 5: 75 U
Detailed description
Seventy-eight patients with upper extremity spasticity after cerebrovascular accident will be recruited and randomly assigned to one of 5 groups. The groups are as followings. Gp 1: placebo group (Normal saline 1.2 ml) Gp 2: Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 15 U Gp 3: Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 30 U Gp 4: Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 50 U Gp 5: Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 70 U According to the group, the injection will be performed to the finger flexor musles (flexor digitorum superficialis and profundus). Outcome measurement will be MAS (Modified ashworth scale), FMA, Wolf Motor Assessment, Cross sectional area measured by Ultrasonography. Patient evaluation will be conducted 2 weeks, 1 months, 2 months, and 3 months after the injection.
Interventions
DRUGNormal Saline 0.9% 1.2 ml
DRUGClostridium Botulinum Toxin Type A (Nabota, DWP 450) 15 U
DRUGClostridium Botulinum Toxin Type A (Nabota, DWP 450) 30 U
DRUGClostridium Botulinum Toxin Type A (Nabota, DWP 450) 50 U
DRUGClostridium Botulinum Toxin Type A (Nabota, DWP 450) 70 U
Sponsors
Daewoong Pharmaceutical Co. LTD.
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* over 6 weeks after stroke onset * MAS (modified Ashworth scale) greater than 2 in finger flexor
Exclusion criteria
* neuromuscular junction disease or motor neuron disease * phenol or alcohol block for the target limbs within 6 months before screening * botulinum toxin injection within 3 months before screening * history or plan for tendon lengthening surgery * significant contracture ormuscle atrophy at the target joint or muscle * concurrent treatment with intrathecal baclofen * hypersensitivity or allergy to study drug or its components * pregnancy or planned pregnancy, breastfeeding * abnormal lab findings for alanine aminotransferase, aspartate aminotransferase, blood urea nitrogen, and serum creatinine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MAS (Modified Ashworth Scale) | baseline | Spasticity measurement measures resistance during passive soft-tissue stretching(taken from Bohannon and Smith, 1987): 0: No increase in muscle tone 1. Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM 2. More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved 3. Considerable increase in muscle tone, passive movement difficult 4. Affected part(s) rigid in flexion or extension |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ultrasonography | baseline | measurement of changes of cross sectional area |
| Fugl Myer Upper Extremity Assessment | baseline | measurement of upper extremity function |
| Wolf Motor Assessment | baseline | measurement of upper extremity function |
Countries
South Korea
Contacts
Primary ContactShi-Uk Lee, MD, PhD
Backup ContactMin Hyung Lee
Outcome results
None listed