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

• Status: Unknown status
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborator: Daewoong Pharmaceutical Co. LTD.
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; onabotulinumtoxinA

Criteria

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.