Clinical trial NCT03517319: Dose-response Relationship of Botullinum Toxin (DWP 450) for Finger Flexor Spasticity
Official title: Dose-response Relationship of Botullinum Toxin (DWP 450) for Finger Flexor Spasticity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Spasticity as Sequela of Stroke
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Daewoong Pharmaceutical Co. LTD.
First posted: 2018-05-07
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: MAS (Modified Ashworth Scale)
timeFrame: baseline
measure: MAS (Modified Ashworth Scale)
timeFrame: 2wks after injection
measure: MAS (Modified Ashworth Scale)
timeFrame: 4wks after injection
measure: MAS (Modified Ashworth Scale)
timeFrame: 8wks after injection
measure: MAS (Modified Ashworth Scale)
timeFrame: 12wks after injection
Secondary outcomes:
measure: Ultrasonography
timeFrame: baseline
measure: Ultrasonography
timeFrame: 2wks after injection
measure: Ultrasonography
timeFrame: 4wks after injection
measure: Ultrasonography
timeFrame: 8wks after injection
measure: Ultrasonography
timeFrame: 12wks after injection
measure: Fugl Myer Upper Extremity Assessment
timeFrame: baseline
measure: Fugl Myer Upper Extremity Assessment
timeFrame: 2 wks after injection
measure: Fugl Myer Upper Extremity Assessment
timeFrame: 4 wks after injection
measure: Fugl Myer Upper Extremity Assessment
timeFrame: 8 wks after injection
measure: Fugl Myer Upper Extremity Assessment
timeFrame: 12 wks after injection
measure: Wolf Motor Assessment
timeFrame: baseline
measure: Wolf Motor Assessment
timeFrame: 2 wks after injection
measure: Wolf Motor Assessment
timeFrame: 4 wks after injection
measure: Wolf Motor Assessment
timeFrame: 8 wks after injection
measure: Wolf Motor Assessment
timeFrame: 12 wks after injection
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul Metropolitan Government-Seoul National University Boramae Medical Center
state: Dong Jak Ku
Study officials:
affiliation: Seoul National University
name: Shi-Uk Lee
role: STUDY_CHAIR
References: