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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meditoxin® | Experimental | Botulinum toxin type A |
|
| Botox® | Active Comparator | Botulinum Toxin type A |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin type A | Drug | Botulinum toxin type A |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline and 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
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
Current Physical, occupational, Splinting therapy
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.
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| Name | Affiliation | Role |
|---|---|---|
| Moon Suk Bang, Ph.D | Seoul National Universtiy Hospital, 101 Daehak-ro Jong-gu, Seoul 110-744, Korea | Principal Investigator |
| Min Ho Chun, Ph.D | Asan Medical Center, 388-1 Pungnap-2 dong, Songpa-Gu, Seoul, 138-736, Korea | Principal Investigator |
| Nam Jong Baik, Ph. D | University Bundang Hospital, Seoul National Univ. Bundang Hospital, Gumi-dong, Bundang-gu, Seongnam-si, Gyeonggi-do, Korea | Principal Investigator |
| Si Uk Lee, Ph.D | SMG-SNU Boramae Medical Center, 41, Borame-Gill, Dong Gjak-Gu, Seoul, 156-707, Seoul, Korea | Principal Investigator |
| Beom Seon Gwon, Ph.D | Dongguk University International Hospital, Siksa-dong, Ilsandong-gu, Goyang-si, Gyeonggi-do, Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26030192 | Derived | 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. |
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Total 9 subjects were prematurely discontinued from the study due to unmet inclusion/exclusion criteria found after randomization, AEs/SAEs, consent withdrawal and follow-up lost: 7 subjects in study group (7.14%) and 2 subjects in control group (2.04%). Thus total 187 subjects (91 in study group; 96 in control group) completed the study.
In this study, total 208 patients were screened and total 196 subjects (98 subjects per group) were randomized, except 12 screening-failures, at 5 study sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | Meditoxin® | Clostridium Botulinum toxin type A, up to total 360U injected into selected sites, Intra-muscle |
| FG001 | Botox® | Clostridium Botulinum toxin type A, up to total 360U injected into selected sites, Intra-muscle |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
FAS
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| ID | Title | Description |
|---|---|---|
| BG000 | Meditoxin® | Botulinum toxin type A |
| BG001 | Botox® | Botulinum Toxin type A |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | The analysis was performed on the Full Analysis Set population which consisted of 94 subjects receiving Meditoxin and 98 subjects for Botox. | Posted | Mean | Standard Deviation | Scores on a MAS Scale | Baseline and 4 weeks |
|
The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection
All AEs reported during the study period were tabulated and AE incidence was determined.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Meditoxin® | Botulinum toxin type A |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatitis toxic | Hepatobiliary disorders | MedDRA(ver. 14.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA(ver. 14.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medytox Inc. | Clinical Development Team of Medytox Inc. | 82-70-8666-6911 | hgpark@medytox.com |
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| ID | Term |
|---|---|
| D009128 | Muscle Spasticity |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| C050008 | 3-deoxyglycero-galacto-nonulosonic acid |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| Botulinum Toxin type A | Drug | Botulinum Toxin type A |
|
|
| Baseline, week 8 and week 12 |
| 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). | Baseline, week 4, week 8 and week 12 |
| 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). | Baseline, week 4, week 8 and week 12 |
| 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). | Baseline, week 4, week 8 and week 12 |
| 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. | week 4, week 8, week 12 |
| 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 | week 4, week 8, week 12 |
| 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. | week 4, week 8, week 12 |
| 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. | week 4, week 8, week 12 |
| 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). | Baseline, week 4, week 8 and week 12 |
| 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). | Baseline, week 4, week 8 and week 12 |
| 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). | Baseline, week 4, week 8 and week 12 |
| 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). | Baseline, week 4, week 8 and week 12 |
| Global Assessment by Investigator | Global assessment evaluated by investigator at week 12 after injection | week 12 |
| Global Assessment by Patient or Caregiver | Global assessment evaluated by patient or caregiver at week 12 after injection | week 12 |
| 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). | Baseline, week 4, week 8 and week 12 |
| 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). | Baseline, week 4, week 8 and week 12 |
| 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). | Baseline, week 4, week 8 and week 12 |
| 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). | Baseline, week 4, week 8 and week 12 |
| Withdrawal by Subject |
|
| Protocol Violation |
|
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| OG001 |
| Botox® |
Botulinum Toxin type A |
|
|
|
| Secondary | 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). | The analysis was performed on the Full Analysis Set population which consisted of 94 subjects receiving Meditoxin and 98 Botox. | Posted | Mean | Standard Deviation | Scores on a MAS scale | Baseline, week 8 and week 12 |
|
|
|
|
| Secondary | 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). | The analysis was performed on the Full Analysis Set population which consisted of 87 subjects receiving Meditoxin and 94 Botox. | Posted | Mean | Standard Deviation | Scores on a MAS Scale | Baseline, week 4, week 8 and week 12 |
|
|
|
|
| Secondary | 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). | The analysis was performed on the Full Analysis Set population which consisted of 82 subjects receiving Meditoxin and 83 Botox. | Posted | Mean | Standard Deviation | Score on a MAS Scale | Baseline, week 4, week 8 and week 12 |
|
|
|
|
| Secondary | 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). | The analysis was performed on the Full Analysis Set population which consisted of 54 subjects receiving Meditoxin and 58 Botox. | Posted | Mean | Standard Deviation | Scores on a MAS Scale | Baseline, week 4, week 8 and week 12 |
|
|
|
|
| Secondary | 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. | The analysis was performed on the Full Analysis Set population which consisted of 94 subjects receiving Meditoxin and 98 Botox. | Posted | Number | Subjects who improved 1-point on MAS | week 4, week 8, week 12 |
|
|
|
|
| Secondary | 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 | The analysis was performed on the Full Analysis Set population which consisted of 87 subjects receiving Meditoxin and 94 Botox. | Posted | Number | Subjects who improved 1-point on MAS | week 4, week 8, week 12 |
|
|
|
|
| Secondary | 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. | The analysis was performed on the Full Analysis Set population which consisted of 82 subjects receiving Meditoxin and 83 Botox. | Posted | Number | Subjects who improved 1-point on MAS | week 4, week 8, week 12 |
|
|
|
|
| Secondary | 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. | The analysis was performed on the Full Analysis Set population which consisted of 54 subjects receiving Meditoxin and 58 Botox. | Posted | Number | Subjects who improved 1-point on MAS | week 4, week 8, week 12 |
|
|
|
|
| Secondary | 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). | The analysis was performed on the Full Analysis Set population which consisted of 39 subjects receiving Meditoxin and 34 Botox. | Posted | Mean | Standard Deviation | Scores on a DAS Scale | Baseline, week 4, week 8 and week 12 |
|
|
|
|
| Secondary | 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). | The analysis was performed on the Full Analysis Set population which consisted of 11 subjects receiving Meditoxin and 15 Botox. | Posted | Mean | Standard Deviation | Scores on a DAS Scale | Baseline, week 4, week 8 and week 12 |
|
|
|
|
| Secondary | 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). | The analysis was performed on the Full Analysis Set population which consisted of 40 subjects receiving Meditoxin and 47 Botox. | Posted | Mean | Standard Deviation | Scores on a DAS Scale | Baseline, week 4, week 8 and week 12 |
|
|
|
|
| Secondary | 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). | The analysis was performed on the Full Analysis Set population which consisted of 4 subjects receiving Meditoxin and 2 Botox. | Posted | Mean | Standard Deviation | Scores on a DAS Scale | Baseline, week 4, week 8 and week 12 |
|
|
|
|
| Secondary | Global Assessment by Investigator | Global assessment evaluated by investigator at week 12 after injection | The analysis was performed on the Full Analysis Set population which consisted of 94 subjects receiving Meditoxin and 98 Botox. | Posted | Number | participants | week 12 |
|
|
|
|
| Secondary | Global Assessment by Patient or Caregiver | Global assessment evaluated by patient or caregiver at week 12 after injection | The analysis was performed on the Full Analysis Set population which consisted of 94 subjects receiving Meditoxin and 98 Botox. | Posted | Number | participants | week 12 |
|
|
|
|
| Secondary | 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). | The analysis was performed on the Full Analysis Set population which consisted of 92 subjects receiving Meditoxin and 98 Botox. | Posted | Mean | Standard Deviation | Score on a Carer Burden Scale | Baseline, week 4, week 8 and week 12 |
|
|
|
|
| Secondary | 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). | The analysis was performed on the Full Analysis Set population which consisted of 92 subjects receiving Meditoxin and 98 Botox. | Posted | Mean | Standard Deviation | Scores on a Carer Burden Scale | Baseline, week 4, week 8 and week 12 |
|
|
|
|
| Secondary | 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). | The analysis was performed on the Full Analysis Set population which consisted of 92 subjects receiving Meditoxin and 98 Botox. | Posted | Mean | Standard Deviation | Scores on a Carer Burden Scale | Baseline, week 4, week 8 and week 12 |
|
|
|
|
| Secondary | 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). | The analysis was performed on the Full Analysis Set population which consisted of 92 subjects receiving Meditoxin and 98 Botox. | Posted | Mean | Standard Deviation | Scores on a Carer Burden Scale | Baseline, week 4, week 8 and week 12 |
|
|
|
|
| 5 |
| 98 |
| 35 |
| 98 |
| EG001 | Botox® | Botulinum Toxin type A | 8 | 98 | 35 | 98 |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA(ver. 14.0) | Systematic Assessment |
|
| Intraventricular haemorrhage | Nervous system disorders | MedDRA(ver. 14.0) | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA(ver. 14.0) | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA(ver. 14.0) | Systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA(ver. 14.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA(ver. 14.0) | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA(ver. 14.0) | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA(ver. 14.0) | Systematic Assessment |
|
| Behcet's syndrome | Immune system disorders | MedDRA(ver. 14.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA(ver. 14.0) | Systematic Assessment |
|
| Pulmonary tuberculosis | Infections and infestations | MedDRA(ver. 14.0) | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA(ver. 14.0) | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA(ver. 14.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA(ver. 14.0) | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA(ver. 14.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA(ver. 14.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA(ver. 14.0) | Systematic Assessment |
|
| Consitipation | Gastrointestinal disorders | MedDRA(ver. 14.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA(ver. 14.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA(ver. 14.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA(ver. 14.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA(ver. 14.0) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA(ver. 14.0) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA(ver. 14.0) | Systematic Assessment |
|
| Injection site haematoma | General disorders | MedDRA(ver. 14.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA(ver. 14.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA(ver. 14.0) | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA(ver. 14.0) | Systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA(ver. 14.0) | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA(ver. 14.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA(ver. 14.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA(ver. 14.0) | Systematic Assessment |
|
| Partial seizures | Nervous system disorders | MedDRA(ver. 14.0) | Systematic Assessment |
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All the results which arise directly or indirectly from the clinical trial in any form shall be the exclusive property of the sponsor.
PIs and the sponsor will discuss, prior to public release of the results, any draft publication or communication made by the investigator. PIs shall not mention any information for a patent or for any intellectual property rights. The sponsor may use or explit all the results at its own discretion, without any limitation to its property right.
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| Week 12 |
|
| Change(Week 8 - Baseline) |
|
| Change(Week12 - Baseline) |
|
| t-test, 2 sided |
| 0.3395 |
| Mean Difference (Final Values) |
| 0.09 |
| 2-Sided |
| Superiority or Other |
| Week 8 |
|
| Week 12 |
|
| Change(Week 4 - Baseline) |
|
| Change(Week 8 - Baseline) |
|
| Change(Week 12 - Baseline) |
|
| t-test, 2 sided |
| 0.0605 |
| Mean Difference (Final Values) |
| -0.2 |
| 2-Sided |
| Superiority or Other |
| Difference between groups in change from baseline to week 12 in elbow flexor MAS score was compared using two sample t-test. | t-test, 2 sided | 0.0429 | Mean Difference (Final Values) | -0.23 | 2-Sided | Superiority or Other |
| Week 8 |
|
| Week 12 |
|
| Change(Week 4 - Baseline) |
|
| Change(Week 8 - Baseline) |
|
| Change(Week 12 - Baseline) |
|
| t-test, 2 sided |
| 0.6024 |
| Mean Difference (Final Values) |
| 0.07 |
| 2-Sided |
| Superiority or Other |
| Difference between groups in change from baseline to week 12 in finger flexor MAS score was compared using two sample t-test. | t-test, 2 sided | 0.9316 | Mean Difference (Final Values) | -0.02 | 2-Sided | Superiority or Other |
| Week 8 |
|
| Week 12 |
|
| Change(Week 4 - Baseline) |
|
| Change(Week 8 - Baseline) |
|
| Change(Week 12 - Baseline) |
|
| t-test, 2 sided |
| 0.3221 |
| Mean Difference (Final Values) |
| 0.15 |
| 2-Sided |
| Superiority or Other |
| Difference between groups in change from baseline to week 12 in thumb flexor MAS score was compared using two sample t-test. | t-test, 2 sided | 0.5930 | Mean Difference (Final Values) | 0.09 | 2-Sided | Superiority or Other |
| Week 12 |
|
Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 8 from baseline in wrist flexor was compared using Pearson's chi-square test.
| Chi-squared |
| 0.9596 |
| Risk Difference (RD) |
| 0.0028 |
| 2-Sided |
| Superiority or Other |
| Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 12 from baseline in wrist flexor was compared using Pearson's chi-square test. | Chi-squared | 0.6164 | Risk Difference (RD) | -0.0304 | 2-Sided | Superiority or Other |
| Week 12 |
|
Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 8 from baseline in elbow flexor was compared using Pearson's chi-square test.
| Chi-squared |
| 0.1176 |
| Risk Difference (RD) |
| 0.1164 |
| 2-Sided |
| Superiority or Other |
| Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 12 from baseline in elbow flexor was compared using Pearson's chi-square test. | Chi-squared | 0.1252 | Risk Difference (RD) | 0.1138 | 2-Sided | Superiority or Other |
| Week 12 |
|
Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 8 from baseline in finger flexor was compared using Pearson's chi-square test
| Chi-squared |
| 0.1329 |
| Risk Difference (RD) |
| -0.1097 |
| 2-Sided |
| Superiority or Other |
| Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 12 from baseline in finger flexor was compared using Pearson's chi-square test | Chi-squared | 0.2611 | Risk Difference (RD) | 0.0853 | 2-Sided | Superiority or Other |
| Week 12 |
|
Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 8 from baseline in thumb flexor was compared using Pearson's chi-square test.
| Chi-squared |
| 0.2007 |
| Risk Difference (RD) |
| -0.1194 |
| 2-Sided |
| Superiority or Other |
| Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 12 from baseline in thumb flexor was compared using Pearson's chi-square test. | Chi-squared | 0.8553 | Risk Difference (RD) | 0.0172 | 2-Sided | Superiority or Other |
| Week 8 |
|
| Week 12 |
|
| Change(Week 4 - Baseline) |
|
| Change(Week 8 - Baseline) |
|
| Change(Week 12 - Baseline) |
|
| Wilcoxon (Mann-Whitney) |
| 0.3233 |
| Mean Difference (Final Values) |
| -0.15 |
| 2-Sided |
| Superiority or Other |
| Difference between groups in change from baseline to week 12 in DAS score of hygiene was compared using wilcoxon rank sum test. | Wilcoxon (Mann-Whitney) | 0.4469 | Mean Difference (Final Values) | -0.12 | 2-Sided | Superiority or Other |
| Week 8 |
|
| Week 12 |
|
| Change(Week 4 - Baseline) |
|
| Change(Week 8 - Baseline) |
|
| Change(Week 12 - Baseline) |
|
| Wilcoxon (Mann-Whitney) |
| 0.1016 |
| Mean Difference (Final Values) |
| 0.41 |
| 2-Sided |
| Superiority or Other |
| Difference between groups in change from baseline to week 12 in DAS score of dressing was compared using wilcoxon rank sum test. | Wilcoxon (Mann-Whitney) | 0.2235 | Mean Difference (Final Values) | 0.32 | 2-Sided | Superiority or Other |
| Week 8 |
|
| Week 12 |
|
| Change(Week 4 - Baseline) |
|
| Change(Week 8 - Baseline) |
|
| Change(Week 12 - Baseline) |
|
| Wilcoxon (Mann-Whitney) |
| 0.6934 |
| Mean Difference (Final Values) |
| -0.04 |
| 2-Sided |
| Superiority or Other |
| Difference between groups in change from baseline to week 12 in DAS score of limb position was compared using wilcoxon rank sum test. | Wilcoxon (Mann-Whitney) | 0.9574 | Mean Difference (Final Values) | 0.01 | 2-Sided | Superiority or Other |
| Week 8 |
|
| Week 12 |
|
| Change(Week 4 - Baseline) |
|
| Change(Week 8 - Baseline) |
|
| Change(Week 12 - Baseline) |
|
| Wilcoxon (Mann-Whitney) |
| 0.7237 |
| Mean Difference (Final Values) |
| -0.25 |
| 2-Sided |
| Superiority or Other |
| Difference between groups in change from baseline to week 12 in DAS score of pain was compared using wilcoxon rank sum test. | Wilcoxon (Mann-Whitney) | 0.4017 | Mean Difference (Final Values) | 0.50 | 2-Sided | Superiority or Other |
| Moderate |
|
| Insufficient |
|
| Moderate |
|
| Insufficient |
|
| Week 8 |
|
| Week 12 |
|
| Change(Week 4 - Baseline) |
|
| Change(Week 8 - Baseline) |
|
| Change(Week 12 - Baseline) |
|
Difference between groups in change from baseline to week 8 in carer burden scale of cleaning the palm was compared using wilcoxon rank sum test.
| Wilcoxon (Mann-Whitney) |
| 0.3702 |
| Mean Difference (Final Values) |
| -0.18 |
| 2-Sided |
| Superiority or Other |
| Difference between groups in change from baseline to week 12 in carer burden scale of cleaning the palm was compared using wilcoxon rank sum test. | Wilcoxon (Mann-Whitney) | 0.1497 | Mean Difference (Final Values) | -0.28 | 2-Sided | Superiority or Other |
| Week 8 |
|
| Week 12 |
|
| Change(Week 4 - Baseline) |
|
| Change(Week 8 - Baseline) |
|
| Change(Week 12 - Baseline) |
|
Difference between groups in change from baseline to week 8 in carer burden scale of cutting the finger-nails was compared using wilcoxon rank sum test.
| Wilcoxon (Mann-Whitney) |
| 0.7302 |
| Mean Difference (Final Values) |
| -0.12 |
| 2-Sided |
| Superiority or Other |
| Difference between groups in change from baseline to week 12 in carer burden scale of cutting the finger-nails was compared using wilcoxon rank sum test. | Wilcoxon (Mann-Whitney) | 0.7715 | Mean Difference (Final Values) | -0.07 | 2-Sided | Superiority or Other |
| Week 8 |
|
| Week 12 |
|
| Change(Week 4 - Baseline) |
|
| Change(Week 8 - Baseline) |
|
| Change(Week 12 - Baseline) |
|
Difference between groups in change from baseline to week 8 in carer burden scale of putting shirts on was compared using wilcoxon rank sum test.
| Wilcoxon (Mann-Whitney) |
| 0.7998 |
| Mean Difference (Final Values) |
| -0.09 |
| 2-Sided |
| Superiority or Other |
| Difference between groups in change from baseline to week 12 in carer burden scale of putting shirts on was compared using wilcoxon rank sum test. | Wilcoxon (Mann-Whitney) | 0.5436 | Mean Difference (Final Values) | -0.13 | 2-Sided | Superiority or Other |
| Week 8 |
|
| Week 12 |
|
| Change(Week 4 - Baseline) |
|
| Change(Week 8 - Baseline) |
|
| Change(Week 12 - Baseline) |
|
Difference between groups in change from baseline to week 8 in carer burden scale of cleaning the armpit was compared using wilcoxon rank sum test.
| Wilcoxon (Mann-Whitney) |
| 0.8884 |
| Mean Difference (Final Values) |
| -0.10 |
| 2-Sided |
| Superiority or Other |
| Difference between groups in change from baseline to week 12 in carer burden scale of cleaning the armpit was compared using wilcoxon rank sum test. | Wilcoxon (Mann-Whitney) | 0.2840 | Mean Difference (Final Values) | -0.27 | 2-Sided | Superiority or Other |