Dose-response Relationship of Botullinum Toxin (DWP 450) for Finger Flexor Spasticity
Dose-response Relationship of Botullinum Toxin (DWP 450) for Finger Flexor Spasticity
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
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.
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.