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

Phase 4

• Conditions: Spasticity as Sequela of Stroke
• Interventions: 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) 50 U; Drug: Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 70 U; Drug: Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 30 U

• Registration Number: NCT03517319
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study Start: 2016-09-01
• Study First Submitted: 2018-04-17
• Status Verified: 2018-05
• Primary Completion: 2018-05
• Study First Submitted QC: 2018-05-03
• Last Update Submitted: 2018-05-03
• Study First Posted: 2018-05-07
• Last Update Posted: 2018-05-07
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 78

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	Normal Saline 0.9% 1.2 ml	Normal Saline 0.9% 1.2 ml will be injected to finger flexor muscles
Treatment dose 15	Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 15 U	Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 15 U will be injected to finger flexor muscles
Treatment dose 50	Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 50 U	Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 50 U will be injected to finger flexor muscles
Treatment dose 70	Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 70 U	Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 70 U will be injected to finger flexor muscles
Treatment dose 30	Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 30 U	Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 30 U will be injected to finger flexor muscles

Primary Outcome Measures

Name	Time	Method
MAS (Modified Ashworth Scale)	12wks after injection	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 Outcome Measures

Name	Time	Method
Ultrasonography	12wks after injection	measurement of changes of cross sectional area
Fugl Myer Upper Extremity Assessment	12 wks after injection	measurement of upper extremity function
Wolf Motor Assessment	12 wks after injection	measurement of upper extremity function

Trial Locations

Locations (1)

Seoul Metropolitan Government-Seoul National University Boramae Medical Center; 🇰🇷 Seoul, Dong Jak Ku, Korea, Republic of