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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-002429-29 | EudraCT Number |
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The aim of this study is to assess longer term safety and effectiveness of Dysport®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dysport | Experimental | 250-1000 units |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin type A | Biological | In this long-term extension study, a dose of 500 units Dysport was administered by intramuscular injection into the clinically indicated neck muscles in a single dosing session in the first treatment cycle. This was the same dose as given in the preceding study NCT00257660 (Y-47-52120-051). Based on individual safety & efficacy, subjects could then receive up to 3 subsequent injections with doses titrated in 250 unit steps, to a minimum of 250 units and a maximum of 1000 units. Retreatment occurred approximately 12-16 weeks after the previous injection, with the exact timing based on clinical need. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline | TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. For each treatment cycle, the change in TWSTRS total score is the score at week 4 minus the score at baseline. | Week 4 follow-up visit |
| Measure | Description | Time Frame |
|---|---|---|
| Toronto Western Spasmodic Torticollis Rating Scale Severity Subscale as a Change From Baseline | TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for severity is from 0 (absence of severity) to 35 (max severity). For each treatment cycle, the change in TWSTRS severity subscale is the score at week 4 minus the score at baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barrow Neurology Clinics at St. Joseph's Hospital and Medical Center | Phoenix | Arizona | 85013 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20359934 | Result | Truong D, Brodsky M, Lew M, Brashear A, Jankovic J, Molho E, Orlova O, Timerbaeva S; Global Dysport Cervical Dystonia Study Group. Long-term efficacy and safety of botulinum toxin type A (Dysport) in cervical dystonia. Parkinsonism Relat Disord. 2010 Jun;16(5):316-23. doi: 10.1016/j.parkreldis.2010.03.002. Epub 2010 Mar 31. | |
| 25324317 |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants.
Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.
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Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
Of the 116 subjects treated in study NCT00257660, 108 subjects enrolled in this extension study NCT00288509 (Y-47-52120-731). Eight subjects completed study NCT00257660 but elected not to enroll in this extension study.
Patients who completed study NCT00257660 (Y-47-52120-051)were recruited in 15 centres in US and 4 centres in Russia from February 2006 to January 2008 to participate in this study NCT00288509 (Y-47-52120-731).
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| ID | Title | Description |
|---|---|---|
| FG000 | Dysport | 250-1000 units |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Cycle 1 |
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| Week 4 follow-up visit |
| Toronto Western Spasmodic Torticollis Rating Scale Disability Subscale Score as a Change From Baseline | TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for disability is from 0 (no disability) to 30 (max disability). For each treatment cycle, the change in TWSTRS disability subscale is the score at week 4 minus the score at baseline. | Week 4 follow-up visit |
| Toronto Western Spasmodic Torticollis Rating Scale Pain Subscale Score as a Change From Baseline | TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for pain is from 0 (no pain) to 20 (max pain). For each treatment cycle, the change in TWSTRS pain subscale is the score at week 4 minus the score at baseline. | Week 4 follow-up visit |
| The Parkinson's and Movement Disorder Institute |
| Fountain Valley |
| California |
| 92708 |
| United States |
| USC School of Medicine | Los Angeles | California | 90033 | United States |
| University of Florida, Dept of Neurology | Gainesville | Florida | 32610 | United States |
| University of Miami, Dept of Neurology | Miami | Florida | 33136 | United States |
| Emory University School of Medicine, Wesley Woods Health Center | Atlanta | Georgia | 30329 | United States |
| University of Iowa, Dept of Neurology | Iowa City | Iowa | 52242 | United States |
| Wayne State University Medical Center | Southfield | Michigan | 48034 | United States |
| Albany Medical Center | Albany | New York | 12205 | United States |
| Beth Israel Medical Center | New York | New York | 10003 | United States |
| Columbia University Medical Center, Neurological Institute | New York | New York | 10032 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| University of Texas Southwest Medical Center, Movement Disorder Clinic | Dallas | Texas | 75309 | United States |
| Baylor College of Medicine, Parkinson's Disease Center and Movement Disorders Clinic | Houston | Texas | 77030 | United States |
| Scientific Research Institute of Neurology, RAMS | Moscow | 123367 | Russia |
| Clinic "Cecil Plus" | Moscow | 125047 | Russia |
| Municipal Multi-Speciality Hospital #2 | Saint Petersburg | 194354 | Russia |
| St Petersburg Pavlov State Medical University | Saint Petersburg | 197022 | Russia |
| Mordin M, Masaquel C, Abbott C, Copley-Merriman C. Factors affecting the health-related quality of life of patients with cervical dystonia and impact of treatment with abobotulinumtoxinA (Dysport): results from a randomised, double-blind, placebo-controlled study. BMJ Open. 2014 Oct 16;4(10):e005150. doi: 10.1136/bmjopen-2014-005150. |
| COMPLETED |
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| NOT COMPLETED |
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| Treatment Cycle 2 |
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| Treatment Cycle 3 |
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| Treatment Cycle 4 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dysport | 250-1000 units |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline | TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. For each treatment cycle, the change in TWSTRS total score is the score at week 4 minus the score at baseline. | The intention to treat population consisted of all 108 subjects who received Dysport. Subjects with incomplete TWSTRS scores were not included in the TWSTRS total score analyses. | Posted | Mean | Standard Deviation | points on a scale | Week 4 follow-up visit |
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| Secondary | Toronto Western Spasmodic Torticollis Rating Scale Severity Subscale as a Change From Baseline | TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for severity is from 0 (absence of severity) to 35 (max severity). For each treatment cycle, the change in TWSTRS severity subscale is the score at week 4 minus the score at baseline. | The intention to treat population consisted of all 108 subjects who received Dysport. All available TWSTRS severity subscale scores have been included in the severity subscale analyses. Subjects excluded from the TWSTRS total score analyses may have their available data included in the TWSTRS severity subscale score analyses. | Posted | Mean | Standard Deviation | points on a scale | Week 4 follow-up visit |
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| Secondary | Toronto Western Spasmodic Torticollis Rating Scale Disability Subscale Score as a Change From Baseline | TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for disability is from 0 (no disability) to 30 (max disability). For each treatment cycle, the change in TWSTRS disability subscale is the score at week 4 minus the score at baseline. | The intention to treat population consisted of all 108 subjects who received Dysport. All available TWSTRS disability subscale scores have been included in the disability subscale analyses. Subjects excluded from the TWSTRS total score analyses may have their available data included in the TWSTRS disability subscale score analyses. | Posted | Mean | Standard Deviation | points on a scale | Week 4 follow-up visit |
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| Secondary | Toronto Western Spasmodic Torticollis Rating Scale Pain Subscale Score as a Change From Baseline | TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for pain is from 0 (no pain) to 20 (max pain). For each treatment cycle, the change in TWSTRS pain subscale is the score at week 4 minus the score at baseline. | The intention to treat population consisted of all 108 subjects who received Dysport. All available TWSTRS pain subscale scores have been included in the pain subscale analyses. Subjects excluded from the TWSTRS total score analyses may have their available data included in the TWSTRS pain subscale score analyses. | Posted | Mean | Standard Deviation | points on a scale | Week 4 follow-up visit |
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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 | 250-1000 units | 2 | 108 | 84 | 108 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysphagia | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
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A publication of results from all sites in this multicenter study is expected. If the sponsor no longer plans this or 6 months after study completion at all sites, the PI may publish the results. He will supply any proposed publication to the sponsor for review and comment at least 30 days before submission for publication. If the sponsor believes a patent application should be filed, the publication will be delayed for another 60 days or until patent filing; with a maximum delay of 90 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director, Medical Development, Neurology | Ipsen | clinical.trials@ipsen.com |
| ID | Term |
|---|---|
| D014103 | Torticollis |
| ID | Term |
|---|---|
| D004421 | Dystonia |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| C542869 | abobotulinumtoxinA |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| 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 |
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| Treatment stopped according to protocol |
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| Change in TWSTRS total score for Treatment Cycle 2 |
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| Baseline TWSTRS total score for Treatment Cycle 2 |
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| Week 4 TWSTRS total score for Treatment Cycle 2 |
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| Change in TWSTRS total score for Treatment Cycle 3 |
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| Baseline TWSTRS total score for Treatment Cycle 3 |
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| Week 4 TWSTRS total score for Treatment Cycle 3 |
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| Change in TWSTRS total score for Treatment Cycle 4 |
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| Baseline TWSTRS total score for Treatment Cycle 4 |
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| Week 4 TWSTRS total score for Treatment Cycle 4 |
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