Back to resultsMEDITOXIN® Versus BOTOX® in the Treatment of Post-stroke Spasticity of the Upper Limb Spasticity
Primary Purpose
Spasticity
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Botulinum toxin type A
Botulinum Toxin type A
Sponsored by
About this trial
This is an interventional treatment trial for Spasticity focused on measuring spasticity, upperlimb, Botulinum toxin
Eligibility Criteria
Inclusion Criteria:
- Male or female patients ≥ 20 years
- ≥ 6 weeks since the last stroke
- ≥ 2 points in the focal spasticity of wrist flexor and ≥ 1 points at least one of elbow flexor and finger flexor as measured on MAS(0 to 4)
- Targeted one functional disability item (i.e., hygiene, dressing, pain, or cosmesis) with a rating of 2 or greater on DAS (0 to 3)
- Informed consent has been obtained.
Exclusion Criteria:
- Neuromuscular disorders such as Lambert-Eaton syndrome, myasthenia gravis, or amyotrophic lateral sclerosis
- History(within 6 months of screening visit) or planned(during study period) treatment with phenol or alcohol injection or surgery in the target limb
- History(within 6 months of screening visit) or planned(during study period) treatment with tendon lengthening in the target limb
- Fixed joint/muscle contracture
- Severe atrophy
- Concurrent treatment with an intrathecal baclofen
- History(within 3 months of screening visit) Planned(during study period) treatment with Botulinum Toxin
- Known allergy or sensitivity to study medication or its components
Concurrent or planed Muscle relaxants and/or benzodiazepine medication
- If patient has taken these medication stable from one month before screening and no treatment changes are not planned during the study, participation is allowed.
Current Physical, occupational, Splinting therapy
- If these therapy regimens will be permitted if they has been stable in the one month before screening;no treatment and no changes are planned during the study.
- Patient who are participating in other clinical trials at the screening
- Females who are pregnant, breatfeeding,or planning a pregnancy during the study period, or female of childbearing potential, not using a reliable means of centraception.
- Patients who are not eligible for this study at the discretion of the investigator.
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Meditoxin®
Botox®
Arm Description
Botulinum toxin type A
Botulinum Toxin type A
Outcomes
Primary Outcome Measures
MAS(Modified Ashworth Scale) of Wrist Flexor
Change from baseline at week 4 for wrist flexor muscle tone as measured on the MAS(Modified Ashworth Scale). The Modified Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Secondary Outcome Measures
MAS(Modified Ashworth Scale) of Wrist Flexor
Change from baseline at week 8 and 12 for wrist flexor muscle tone as measured on the MAS(Modified Ashworth Scale).
The Modified Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
MAS(Modified Ashworth Score) of Elbow Flexor
Change from baseline at week 4, week 8 and 12 for elbow flexor muscle tone as measured on the MAS(Modified Ashworth Scale).
The Modified Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
MAS(Modified Ashworth Score) of Finger Flexor
Change from baseline at week 4, week 8 and 12 for finger flexor muscle tone as measured on the MAS(Modified Ashworth Scale).
The Modified Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
MAS(Modified Ashworth Score) of Thumb Flexor
Change from baseline at week 4, 8, 12 for thumb flexor muscle tone as measured on MAS.
The Modified Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Improvement Rate on the MAS(Modified Ashworth Score) of Wrist Flexor
Improvement in the injected site muscle tone at week 4, 8 and 12 as measured by MAS(Modified Ashworth Score) of wrist flexor.
* A treatment response is defined as 1-point improvement on the MAS(Modified Ashworth Score) of injection site.
Improvement Rate on the MAS(Modified Ashworth Score) of Elbow Flexor
Improvement in the injected site muscle tone at week 4, 8 and 12 as measured by MAS(Modified Ashworth Score) of elbow flexor.
* A treatment response is defined as 1-point improvement on the MAS(Modified Ashworth Score) of injection site
Improvement Rate on the MAS(Modified Ashworth Score) of Finger Flexor
Improvement in the injected site muscle tone at week 4, 8 and 12 as measured by MAS(Modified Ashworth Score) of finger flexor.
* A treatment response is defined as 1-point improvement on the MAS(Modified Ashworth Score) of injection site.
Improvement Rate on the MAS(Modified Ashworth Score) of Thumb Flexor
Improvement in the injected site muscle tone at week 4, 8 and 12 as measured by MAS(Modified Ashworth Score) of thumb flexor.
* A treatment response is defined as 1-point improvement on the MAS(Modified Ashworth Score) of injection site.
DAS(Disability Assessment Scale) of Hygiene
Change From Baseline to week 4, 8, 12 in the DAS(Disability Assessment Scale) for the Principal Therapeutic Target as Hygiene.
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
DAS(Disability Assessment Scale) of Dressing
Change From Baseline to week 4, 8, 12 in the DAS(Disability Assessment Scale) for the Principal Therapeutic Target as Dressing. The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
DAS(Disability Assessment Scale) of Limb Position
Change From Baseline to week 4, 8, 12 in the DAS(Disability Assessment Scale) for the Principal Therapeutic Target as Limb Position.
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
DAS(Disability Assessment Scale) of Pain
Change From Baseline to week 4, 8, 12 in the DAS(Disability Assessment Scale) for the Principal Therapeutic Target as Pain.
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Global Assessment by Investigator
Global assessment evaluated by investigator at week 12 after injection
Global Assessment by Patient or Caregiver
Global assessment evaluated by patient or caregiver at week 12 after injection
Carer Burden Scale of Cleaning the Palm
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
Carer Burden Scale of Cutting the Finger-nails
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
Carer Burden Scale of Putting Shirts on
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
Carer Burden Scale of Cleaning the Armpit
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01313767
Brief Title
MEDITOXIN® Versus BOTOX® in the Treatment of Post-stroke Spasticity of the Upper Limb Spasticity
Official Title
A Randomized, Double Blind, Multi-center, Active Drug Controlled Clinical Trial to Compare the Efficacy and Safety of MEDITOXIN® Versus BOTOX® in Treatment of Post Stroke Upper Limb Spasticity
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medy-Tox
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is a randomized, double blind, multi-center, active drug controlled, phase III clinical trial to compare the efficacy and safety of MEDITOXIN® versus BOTOX® in treatment of post stroke upper limb(wrist, finger, thumb) spasticity
Approximately 196 subjects(1:1 group ratio)will be enrolled. Subjects will receive a single treatment of intramuscular Investigational product up to 360U. The subjects will be observed every 4 weeks until 12 weeks post injection. Outcome measures include Modified Ashworth Scale (MAS), Disability Assessment Scale (DAS), Global Assessment Scale(patient or caregiver/investigator) and Carer burden scale. The primary efficacy endpoint is the change from baseline at week 4 for wrist flexor muscle tone as measured on the Modified Ashworth Scale. Safety parameters will also be measured including adverse events, vital signs and clinical laboratory tests (haematology, serum chemistry and urinanalysis).
Detailed Description
Each completed subject will attend 4~5 clinic visits. The maximum study duration is 15 weeks. Only one upper limb (eligible inclusion/exclusion criteria) will be injected and evaluated in the study. Maximun injection dose is 360U.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spasticity
Keywords
spasticity, upperlimb, Botulinum toxin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
196 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Meditoxin®
Arm Type
Experimental
Arm Description
Botulinum toxin type A
Arm Title
Botox®
Arm Type
Active Comparator
Arm Description
Botulinum Toxin type A
Intervention Type
Drug
Intervention Name(s)
Botulinum toxin type A
Other Intervention Name(s)
Neuronox®, Siax®
Intervention Description
Botulinum toxin type A
Intervention Type
Drug
Intervention Name(s)
Botulinum Toxin type A
Other Intervention Name(s)
Botox®
Intervention Description
Botulinum Toxin type A
Primary Outcome Measure Information:
Title
MAS(Modified Ashworth Scale) of Wrist Flexor
Description
Change from baseline at week 4 for wrist flexor muscle tone as measured on the MAS(Modified Ashworth Scale). The Modified Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time Frame
Baseline and 4 weeks
Secondary Outcome Measure Information:
Title
MAS(Modified Ashworth Scale) of Wrist Flexor
Description
Change from baseline at week 8 and 12 for wrist flexor muscle tone as measured on the MAS(Modified Ashworth Scale).
The Modified Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time Frame
Baseline, week 8 and week 12
Title
MAS(Modified Ashworth Score) of Elbow Flexor
Description
Change from baseline at week 4, week 8 and 12 for elbow flexor muscle tone as measured on the MAS(Modified Ashworth Scale).
The Modified Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time Frame
Baseline, week 4, week 8 and week 12
Title
MAS(Modified Ashworth Score) of Finger Flexor
Description
Change from baseline at week 4, week 8 and 12 for finger flexor muscle tone as measured on the MAS(Modified Ashworth Scale).
The Modified Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time Frame
Baseline, week 4, week 8 and week 12
Title
MAS(Modified Ashworth Score) of Thumb Flexor
Description
Change from baseline at week 4, 8, 12 for thumb flexor muscle tone as measured on MAS.
The Modified Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time Frame
Baseline, week 4, week 8 and week 12
Title
Improvement Rate on the MAS(Modified Ashworth Score) of Wrist Flexor
Description
Improvement in the injected site muscle tone at week 4, 8 and 12 as measured by MAS(Modified Ashworth Score) of wrist flexor.
* A treatment response is defined as 1-point improvement on the MAS(Modified Ashworth Score) of injection site.
Time Frame
week 4, week 8, week 12
Title
Improvement Rate on the MAS(Modified Ashworth Score) of Elbow Flexor
Description
Improvement in the injected site muscle tone at week 4, 8 and 12 as measured by MAS(Modified Ashworth Score) of elbow flexor.
* A treatment response is defined as 1-point improvement on the MAS(Modified Ashworth Score) of injection site
Time Frame
week 4, week 8, week 12
Title
Improvement Rate on the MAS(Modified Ashworth Score) of Finger Flexor
Description
Improvement in the injected site muscle tone at week 4, 8 and 12 as measured by MAS(Modified Ashworth Score) of finger flexor.
* A treatment response is defined as 1-point improvement on the MAS(Modified Ashworth Score) of injection site.
Time Frame
week 4, week 8, week 12
Title
Improvement Rate on the MAS(Modified Ashworth Score) of Thumb Flexor
Description
Improvement in the injected site muscle tone at week 4, 8 and 12 as measured by MAS(Modified Ashworth Score) of thumb flexor.
* A treatment response is defined as 1-point improvement on the MAS(Modified Ashworth Score) of injection site.
Time Frame
week 4, week 8, week 12
Title
DAS(Disability Assessment Scale) of Hygiene
Description
Change From Baseline to week 4, 8, 12 in the DAS(Disability Assessment Scale) for the Principal Therapeutic Target as Hygiene.
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time Frame
Baseline, week 4, week 8 and week 12
Title
DAS(Disability Assessment Scale) of Dressing
Description
Change From Baseline to week 4, 8, 12 in the DAS(Disability Assessment Scale) for the Principal Therapeutic Target as Dressing. The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time Frame
Baseline, week 4, week 8 and week 12
Title
DAS(Disability Assessment Scale) of Limb Position
Description
Change From Baseline to week 4, 8, 12 in the DAS(Disability Assessment Scale) for the Principal Therapeutic Target as Limb Position.
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time Frame
Baseline, week 4, week 8 and week 12
Title
DAS(Disability Assessment Scale) of Pain
Description
Change From Baseline to week 4, 8, 12 in the DAS(Disability Assessment Scale) for the Principal Therapeutic Target as Pain.
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time Frame
Baseline, week 4, week 8 and week 12
Title
Global Assessment by Investigator
Description
Global assessment evaluated by investigator at week 12 after injection
Time Frame
week 12
Title
Global Assessment by Patient or Caregiver
Description
Global assessment evaluated by patient or caregiver at week 12 after injection
Time Frame
week 12
Title
Carer Burden Scale of Cleaning the Palm
Description
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
Time Frame
Baseline, week 4, week 8 and week 12
Title
Carer Burden Scale of Cutting the Finger-nails
Description
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
Time Frame
Baseline, week 4, week 8 and week 12
Title
Carer Burden Scale of Putting Shirts on
Description
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
Time Frame
Baseline, week 4, week 8 and week 12
Title
Carer Burden Scale of Cleaning the Armpit
Description
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
Time Frame
Baseline, week 4, week 8 and week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patients ≥ 20 years
≥ 6 weeks since the last stroke
≥ 2 points in the focal spasticity of wrist flexor and ≥ 1 points at least one of elbow flexor and finger flexor as measured on MAS(0 to 4)
Targeted one functional disability item (i.e., hygiene, dressing, pain, or cosmesis) with a rating of 2 or greater on DAS (0 to 3)
Informed consent has been obtained.
Exclusion Criteria:
Neuromuscular disorders such as Lambert-Eaton syndrome, myasthenia gravis, or amyotrophic lateral sclerosis
History(within 6 months of screening visit) or planned(during study period) treatment with phenol or alcohol injection or surgery in the target limb
History(within 6 months of screening visit) or planned(during study period) treatment with tendon lengthening in the target limb
Fixed joint/muscle contracture
Severe atrophy
Concurrent treatment with an intrathecal baclofen
History(within 3 months of screening visit) Planned(during study period) treatment with Botulinum Toxin
Known allergy or sensitivity to study medication or its components
Concurrent or planed Muscle relaxants and/or benzodiazepine medication
If patient has taken these medication stable from one month before screening and no treatment changes are not planned during the study, participation is allowed.
Current Physical, occupational, Splinting therapy
If these therapy regimens will be permitted if they has been stable in the one month before screening;no treatment and no changes are planned during the study.
Patient who are participating in other clinical trials at the screening
Females who are pregnant, breatfeeding,or planning a pregnancy during the study period, or female of childbearing potential, not using a reliable means of centraception.
Patients who are not eligible for this study at the discretion of the investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moon Suk Bang, Ph.D
Organizational Affiliation
Seoul National Universtiy Hospital, 101 Daehak-ro Jong-gu, Seoul 110-744, Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Min Ho Chun, Ph.D
Organizational Affiliation
Asan Medical Center, 388-1 Pungnap-2 dong, Songpa-Gu, Seoul, 138-736, Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nam Jong Baik, Ph. D
Organizational Affiliation
University Bundang Hospital, Seoul National Univ. Bundang Hospital, Gumi-dong, Bundang-gu, Seongnam-si, Gyeonggi-do, Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Si Uk Lee, Ph.D
Organizational Affiliation
SMG-SNU Boramae Medical Center, 41, Borame-Gill, Dong Gjak-Gu, Seoul, 156-707, Seoul, Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Beom Seon Gwon, Ph.D
Organizational Affiliation
Dongguk University International Hospital, Siksa-dong, Ilsandong-gu, Goyang-si, Gyeonggi-do, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
26030192
Citation
Seo HG, Paik NJ, Lee SU, Oh BM, Chun MH, Kwon BS, Bang MS. Neuronox versus BOTOX in the Treatment of Post-Stroke Upper Limb Spasticity: A Multicenter Randomized Controlled Trial. PLoS One. 2015 Jun 1;10(6):e0128633. doi: 10.1371/journal.pone.0128633. eCollection 2015.
Results Reference
derived
Learn more about this trial
MEDITOXIN® Versus BOTOX® in the Treatment of Post-stroke Spasticity of the Upper Limb Spasticity
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