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

Seoul National University

Status and phase: Unknown; Phase 4

Conditions: Spasticity as Sequela of Stroke

Treatments: Drug: Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 70 U; 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: Normal Saline 0.9% 1.2 ml

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03517319

26-2016-103

Details and patient eligibility

About

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

Full 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.

Enrollment: 78 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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78 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Normal Saline 0.9% 1.2 ml will be injected to finger flexor muscles

Treatment:

Drug: Normal Saline 0.9% 1.2 ml

Treatment dose 15

Experimental group

Description:

Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 15 U will be injected to finger flexor muscles

Treatment:

Drug: Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 15 U

Treatment dose 30

Experimental group

Description:

Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 30 U will be injected to finger flexor muscles

Treatment:

Drug: Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 30 U

Treatment dose 50

Experimental group

Description:

Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 50 U will be injected to finger flexor muscles

Treatment:

Drug: Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 50 U

Treatment dose 70

Experimental group

Description:

Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 70 U will be injected to finger flexor muscles

Treatment:

Drug: Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 70 U