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

NCT03517319 | Unknown Phase 4 DMC

• 1 other identifier: 26-2016-103
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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

Conditions

Spasticity as Sequela of Stroke

Outcome Measures

Primary Outcomes (5)

• 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 1. 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 2. More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved 3. Considerable increase in muscle tone, passive movement difficult 4. Affected part(s) rigid in flexion or extension

  baseline

• 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 1. 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 2. More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved 3. Considerable increase in muscle tone, passive movement difficult 4. Affected part(s) rigid in flexion or extension

  2wks after injection

• 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 1. 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 2. More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved 3. Considerable increase in muscle tone, passive movement difficult 4. Affected part(s) rigid in flexion or extension

  4wks after injection

• 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 1. 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 2. More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved 3. Considerable increase in muscle tone, passive movement difficult 4. Affected part(s) rigid in flexion or extension

  8wks after injection

• 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 1. 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 2. More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved 3. Considerable increase in muscle tone, passive movement difficult 4. Affected part(s) rigid in flexion or extension

  12wks after injection

Secondary Outcomes (15)

• Ultrasonography

  baseline

• Ultrasonography

  2wks after injection

• Ultrasonography

  4wks after injection

• Ultrasonography

  8wks after injection

• Ultrasonography

  12wks after injection

Study Arms (5)

Placebo

PLACEBO COMPARATOR

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

Drug: Normal Saline 0.9% 1.2 ml

Treatment dose 15

EXPERIMENTAL

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

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

Treatment dose 30

EXPERIMENTAL

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

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

Treatment dose 50

EXPERIMENTAL

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

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

Treatment dose 70

EXPERIMENTAL

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

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

Interventions

Normal Saline 0.9% 1.2 ml DRUG

Placebo

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

Also known as: Nabota (DWP 450)

Treatment dose 15

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

Also known as: Nabota (DWP 450)

Treatment dose 30

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

Also known as: Nabota (DWP 450)

Treatment dose 50

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

Also known as: Nabota (DWP 450)

Treatment dose 70

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• over 6 weeks after stroke onset
• MAS (modified Ashworth scale) greater than 2 in finger flexor

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Daewoong Pharmaceutical Co. LTD.: collaborator

Study Sites (1)

Seoul Metropolitan Government-Seoul National University Boramae Medical Center

Seoul, Dong Jak Ku, 156-707, South Korea

RECRUITING

MeSH Terms

Interventions

Saline Solution; Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Shi-Uk Lee

  Seoul National University

  STUDY CHAIR

Central Study Contacts

Shi-Uk Lee, MD, PhD

CONTACT

shiuk.lee@gmail.com

Min Hyung Lee

CONTACT

0206330@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: May 7, 2018
• Study Start: September 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: June 1, 2018
• Last Updated: May 7, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)