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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-01

Study Completion Date

2018-06-30

Brief Summary

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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

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Detailed Description

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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

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Spasticity as Sequela of Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Normal Saline 0.9% 1.2 ml

Intervention Type DRUG

Treatment dose 15

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Treatment dose 30

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Treatment dose 50

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Treatment dose 70

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Interventions

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Normal Saline 0.9% 1.2 ml

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG

Other Intervention Names

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Nabota (DWP 450) Nabota (DWP 450) Nabota (DWP 450) Nabota (DWP 450)

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No