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

Spasticity as Sequela of Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03517319
• Other study ID #: 26-2016-103
• Status: Recruiting
• Phase: Phase 4
• 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
• 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.

Related Conditions & MeSH terms

• Muscle Spasticity
• Spasticity as Sequela of Stroke

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