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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03517319
Other study ID # 26-2016-103
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date September 1, 2016
Est. completion date June 2018

Study information

Verified date May 2018
Source Seoul National University Hospital
Contact Shi-Uk Lee, MD, PhD
Email shiuk.lee@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 78
Est. completion date June 2018
Est. primary completion date May 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Normal Saline 0.9% 1.2 ml

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

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

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

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


Locations

Country Name City State
Korea, Republic of Seoul Metropolitan Government-Seoul National University Boramae Medical Center Seoul Dong Jak Ku

Sponsors (2)

Lead Sponsor Collaborator
Seoul National University Hospital Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary MAS (Modified Ashworth Scale) Spasticity measurement measures resistance during passive soft-tissue stretching(taken from Bohannon and Smith, 1987):
0: No increase in muscle tone
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
More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved
Considerable increase in muscle tone, passive movement difficult
Affected part(s) rigid in flexion or extension
baseline
Primary MAS (Modified Ashworth Scale) Spasticity measurement measures resistance during passive soft-tissue stretching(taken from Bohannon and Smith, 1987):
0: No increase in muscle tone
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
More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved
Considerable increase in muscle tone, passive movement difficult
Affected part(s) rigid in flexion or extension
2wks after injection
Primary MAS (Modified Ashworth Scale) Spasticity measurement measures resistance during passive soft-tissue stretching(taken from Bohannon and Smith, 1987):
0: No increase in muscle tone
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
More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved
Considerable increase in muscle tone, passive movement difficult
Affected part(s) rigid in flexion or extension
4wks after injection
Primary MAS (Modified Ashworth Scale) Spasticity measurement measures resistance during passive soft-tissue stretching(taken from Bohannon and Smith, 1987):
0: No increase in muscle tone
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
More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved
Considerable increase in muscle tone, passive movement difficult
Affected part(s) rigid in flexion or extension
8wks after injection
Primary MAS (Modified Ashworth Scale) Spasticity measurement measures resistance during passive soft-tissue stretching(taken from Bohannon and Smith, 1987):
0: No increase in muscle tone
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
More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved
Considerable increase in muscle tone, passive movement difficult
Affected part(s) rigid in flexion or extension
12wks after injection
Secondary Ultrasonography measurement of changes of cross sectional area baseline
Secondary Ultrasonography measurement of changes of cross sectional area 2wks after injection
Secondary Ultrasonography measurement of changes of cross sectional area 4wks after injection
Secondary Ultrasonography measurement of changes of cross sectional area 8wks after injection
Secondary Ultrasonography measurement of changes of cross sectional area 12wks after injection
Secondary Fugl Myer Upper Extremity Assessment measurement of upper extremity function baseline
Secondary Fugl Myer Upper Extremity Assessment measurement of upper extremity function 2 wks after injection
Secondary Fugl Myer Upper Extremity Assessment measurement of upper extremity function 4 wks after injection
Secondary Fugl Myer Upper Extremity Assessment measurement of upper extremity function 8 wks after injection
Secondary Fugl Myer Upper Extremity Assessment measurement of upper extremity function 12 wks after injection
Secondary Wolf Motor Assessment measurement of upper extremity function baseline
Secondary Wolf Motor Assessment measurement of upper extremity function 2 wks after injection
Secondary Wolf Motor Assessment measurement of upper extremity function 4 wks after injection
Secondary Wolf Motor Assessment measurement of upper extremity function 8 wks after injection
Secondary Wolf Motor Assessment measurement of upper extremity function 12 wks after injection
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