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| Name | Class |
|---|---|
| Ipsen | INDUSTRY |
| Medical Research Collaborating Center, Seoul, Korea | OTHER |
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dysport® to Botox® | Experimental | Dysport® injection in first intervention period and Botox® in second intervention period (after washout period) cross over injection of Dysport® (abobotulinumtoxinA) and Botox® (onabotulinumtoxinA) |
|
| Botox® to Dysport® | Experimental | Botox® injection in first intervention period and Dysport® in second intervention period (after washout period) cross over injection of Dysport® (abobotulinumtoxinA) and Botox® (onabotulinumtoxinA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dysport® (abobotulinumtoxinA) | Drug | Cross over injection of Dysport® (<500IU), Botox® (200IU)assuming a bioequivalence ratio of 2.5:1 units |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of Total Tsui Score at 4 Weeks From Baseline | Tsui scale is an impairment scale which evaluates the amplitude and duration of sustained posture and intermittent movements of the head, as well as the presence of shoulder elevation and tremor. Tsui scale (range: 0-25, higher values represent worse cervical dystonia.) Negative numbers to represent decreases of Tsui scale. | 4 weeks after injection from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of Total TWSTRS Score at 4 Weeks From Baseline | TWSTRS (Toronto western spasmodic torticollis rating scale) The TWSTRS is a composite scale which covers different features of cervical dystonia(CD). The first part is based on the physical findings (severity subscale), the second part rates disability, and the third part pain. (range: 0-80, higher values represent worse cervical dystonia.) Details of the TWSTRS are displayed on the Web site http://www.wemove.org. Negative numbers to represent decreases of TWSTRS. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of Tsui Score at Each Visit From Baseline | Tsui scale (range: 0-25, higher values represent worse cervical dystonia.) Negative numbers to represent decreases of Tsui scale. | 8, 12 and 16 weeks after injection |
| Reduction of Total TWSTRS at Each Visit From Baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beom S Jeon, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bundang Seoul Natiuonal University Hospital | Seongnam-si | Gyeonggi-do | 463-070 | South Korea | ||
| Dong-A University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25476727 | Derived | Yun JY, Kim JW, Kim HT, Chung SJ, Kim JM, Cho JW, Lee JY, Lee HN, You S, Oh E, Jeong H, Kim YE, Kim HJ, Lee WY, Jeon BS. Dysport and Botox at a ratio of 2.5:1 units in cervical dystonia: a double-blind, randomized study. Mov Disord. 2015 Feb;30(2):206-13. doi: 10.1002/mds.26085. Epub 2014 Dec 5. |
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103 participants recruited; 103 screened, 1 excluded (1 refused participation).
Participants recruited from movement disorder clinics at 7 hospitals in Korea, between August 2009 and March 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dysport® First, Then Botox® | Dysport® injection in first intervention period and Botox® in second intervention period (after washout period) |
| FG001 | Botox® First, Then Dysport® | Botox® injection in first intervention period and Dysport® in second intervention period (after washout period) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
|
| |||||||||||||||||||||
| Washout Period of 4 Weeks |
| ||||||||||||||||||||||
| Second Intervention |
|
All analyses were performed on the modified intention-to-treat (mITT) basis, with all subjects included in the two treatment challenges.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dysport® First, Then Botox® | Dysport® injection in first intervention period and Botox® in second intervention period (after washout period) |
| BG001 | Botox® First, Then Dysport® |
| 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 | Reduction of Total Tsui Score at 4 Weeks From Baseline | Tsui scale is an impairment scale which evaluates the amplitude and duration of sustained posture and intermittent movements of the head, as well as the presence of shoulder elevation and tremor. Tsui scale (range: 0-25, higher values represent worse cervical dystonia.) Negative numbers to represent decreases of Tsui scale. | Posted | Mean | Standard Deviation | units on a scale | 4 weeks after injection from baseline |
|
4 Months
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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 | Dysport® (abobotulinumtoxinA) | Dysport® administered in either first intervention period or second intervention period |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Muscle weakness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| BS Jeon | Seoul National University Hospital | +82220722876 | brain@snu.ac.kr |
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| ID | Term |
|---|---|
| D014103 | Torticollis |
| ID | Term |
|---|---|
| D004421 | Dystonia |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C542869 | abobotulinumtoxinA |
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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|
| Botox® (onabotulinumtoxinA) | Drug | Cross over injection of Dysport® (<500IU), Botox® (200IU)assuming a bioequivalence ratio of 2.5:1 units |
|
|
| 4 weeks after injection from baseline |
| CGI-I (Clinical Global Impression of Illness) | The proportion of patients with 'normal/ not at all ill' or 'borderline mildly ill' on the CGI (Clinical global impression of illness, CGI-I) 1 = normal / not at all ill'; 2 = 'borderline mildly ill'; 3 = 'mildly ill'; 4 = 'moderlately ill'; 5 = 'markedly ill'; 6 = 'severely ill'; 7 = 'the most extremely ill'. | 4, 8, 12 and 16 weeks after injection |
| PGI-I (Patient's Global Impression of Improvement) | The proportion of patients with 'very much improved' or 'much improved' on the PGI (Patient's global impression of impairment, PGI-I) 1 = very much improved, 2= much improved, 3 = slightly improved, 4 = no change, 5 = slightly aggravated, 6 = much aggravated, and 7 = very much aggravated | 4, 8, 12 and 16 weeks after injection |
TWSTRS scale (Toronto western spasmodic torticollis rating scale, range: 0-80, higher values represent worse cervical dystonia.) Negative numbers to represent decreases of TWSTRS scale. |
| 8, 12 and 16 weeks after injection |
| Reduction of Pain Associated With Cervical Dystonia at Each Visit From Baseline | Pain subscale of TWSTRS scale.(Range: 0-20) Negative numbers to represent decreases of TWSTRS pain subscale. | 4, 8, 12 and 16 weeks after injection |
| Busan |
| 602-715 |
| South Korea |
| Hanyang University Hospital | Seoul | 133-792 | South Korea |
| Samsung Medical Center | Seoul | 135-710 | South Korea |
| Asan Medical Center | Seoul | 138-736 | South Korea |
| Boramae City Hospital | Seoul | 156-707 | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
Botox® injection in first intervention period and Dysport® in second intervention period (after washout period)
| BG002 | 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 |
|
|
|
|
| Secondary | Reduction of Total TWSTRS Score at 4 Weeks From Baseline | TWSTRS (Toronto western spasmodic torticollis rating scale) The TWSTRS is a composite scale which covers different features of cervical dystonia(CD). The first part is based on the physical findings (severity subscale), the second part rates disability, and the third part pain. (range: 0-80, higher values represent worse cervical dystonia.) Details of the TWSTRS are displayed on the Web site http://www.wemove.org. Negative numbers to represent decreases of TWSTRS. | Posted | Mean | Standard Deviation | units on a scale | 4 weeks after injection from baseline |
|
|
|
| Other Pre-specified | Reduction of Tsui Score at Each Visit From Baseline | Tsui scale (range: 0-25, higher values represent worse cervical dystonia.) Negative numbers to represent decreases of Tsui scale. | Posted | Mean | Standard Deviation | units on a scale | 8, 12 and 16 weeks after injection |
|
|
|
| Secondary | CGI-I (Clinical Global Impression of Illness) | The proportion of patients with 'normal/ not at all ill' or 'borderline mildly ill' on the CGI (Clinical global impression of illness, CGI-I) 1 = normal / not at all ill'; 2 = 'borderline mildly ill'; 3 = 'mildly ill'; 4 = 'moderlately ill'; 5 = 'markedly ill'; 6 = 'severely ill'; 7 = 'the most extremely ill'. | Posted | Number | percentage of participants scoring 1or2 | 4, 8, 12 and 16 weeks after injection |
|
|
|
| Secondary | PGI-I (Patient's Global Impression of Improvement) | The proportion of patients with 'very much improved' or 'much improved' on the PGI (Patient's global impression of impairment, PGI-I) 1 = very much improved, 2= much improved, 3 = slightly improved, 4 = no change, 5 = slightly aggravated, 6 = much aggravated, and 7 = very much aggravated | Posted | Number | percentage of patients scoring 1 or 2 | 4, 8, 12 and 16 weeks after injection |
|
|
|
| Other Pre-specified | Reduction of Total TWSTRS at Each Visit From Baseline | TWSTRS scale (Toronto western spasmodic torticollis rating scale, range: 0-80, higher values represent worse cervical dystonia.) Negative numbers to represent decreases of TWSTRS scale. | Posted | Mean | Standard Deviation | units on a scale | 8, 12 and 16 weeks after injection |
|
|
|
| Other Pre-specified | Reduction of Pain Associated With Cervical Dystonia at Each Visit From Baseline | Pain subscale of TWSTRS scale.(Range: 0-20) Negative numbers to represent decreases of TWSTRS pain subscale. | Posted | Mean | Standard Deviation | units on a scale | 4, 8, 12 and 16 weeks after injection |
|
|
|
| 0 |
| 94 |
| 0 |
| 94 |
| 14 |
| 94 |
| EG001 | Botox® (onabotulinumtoxinA) | Botox® administered in either first intervention period or second intervention period | 0 | 94 | 0 | 94 | 19 | 94 |
| Dysphagia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Pain on neck and shoulder | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
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| 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 |
| Reduction in Tsui Score at 16 Weeks from Baseline |
|
| 12 weeks after injection |
|
| 16 weeks after injection |
|
| 12 weeks after injection |
|
| 16 weeks after injection |
|
| Reduction of TWSTRS from Baseline at 16 Weeks |
|
| 12 weeks after injections |
|
| 16 weeks after injections |
|