NCT03517319

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spasticity as Sequela of Stroke

Interventions

Type	Name	Description
DRUG	Normal Saline 0.9% 1.2 ml
DRUG	Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 15 U
DRUG	Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 30 U
DRUG	Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 50 U
DRUG	Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 70 U

Timeline

• Start date: 2016-09-01
• Primary completion: 2018-05-01
• Completion: 2018-06-01
• First posted: 2018-05-07
• Last updated: 2018-05-07

Locations

1 site across 1 country: South Korea