Back to resultsOpen-label Extension Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia
Primary Purpose
Cervical Dystonia
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Botulinum toxin type A
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Dystonia
Eligibility Criteria
Inclusion Criteria: Subjects enrolled in the Y-47-52120-051 study, who have completed all study visits up to Week 12, or up to Week 4 in the event of an early withdrawal Returned to pre-treatment status as judged by the Investigator Exclusion Criteria: Pure anterocollis or pure retrocollis Known antibodies to botulinum toxin type A Requirement for botulinum toxin injections to site(s) other than the neck and unable to avoid such treatment for the duration of the study Known significant underlying swallowing or respiratory abnormality which might be exacerbated by botulinum toxin treatment
Sites / Locations
- Barrow Neurology Clinics at St. Joseph's Hospital and Medical Center
- The Parkinson's and Movement Disorder Institute
- USC School of Medicine
- University of Florida, Dept of Neurology
- University of Miami, Dept of Neurology
- Emory University School of Medicine, Wesley Woods Health Center
- University of Iowa, Dept of Neurology
- Wayne State University Medical Center
- Albany Medical Center
- Beth Israel Medical Center
- Columbia University Medical Center, Neurological Institute
- Allegheny General Hospital
- University of Texas Southwest Medical Center, Movement Disorder Clinic
- Baylor College of Medicine, Parkinson's Disease Center and Movement Disorders Clinic
- Scientific Research Institute of Neurology, RAMS
- Clinic "Cecil Plus"
- Municipal Multi-Speciality Hospital #2
- St Petersburg Pavlov State Medical University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dysport
Arm Description
250-1000 units
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00288509
Brief Title
Open-label Extension Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia
Official Title
A Phase III, Prospective, Multicenter, Open-label Extension Study to Assess the Longer Term Safety and Efficacy of Repeated Treatment of Dysport® Intramuscular Injection in the Treatment of Cervical Dystonia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to assess longer term safety and effectiveness of Dysport®.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Dystonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dysport
Arm Type
Experimental
Arm Description
250-1000 units
Intervention Type
Biological
Intervention Name(s)
Botulinum toxin type A
Other Intervention Name(s)
AbobotulinumtoxinA (Dysport®)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline
Description
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.
Time Frame
Week 4 follow-up visit
Secondary Outcome Measure Information:
Title
Toronto Western Spasmodic Torticollis Rating Scale Severity Subscale as a Change From Baseline
Description
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.
Time Frame
Week 4 follow-up visit
Title
Toronto Western Spasmodic Torticollis Rating Scale Disability Subscale Score as a Change From Baseline
Description
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.
Time Frame
Week 4 follow-up visit
Title
Toronto Western Spasmodic Torticollis Rating Scale Pain Subscale Score as a Change From Baseline
Description
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.
Time Frame
Week 4 follow-up visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects enrolled in the Y-47-52120-051 study, who have completed all study visits up to Week 12, or up to Week 4 in the event of an early withdrawal
Returned to pre-treatment status as judged by the Investigator
Exclusion Criteria:
Pure anterocollis or pure retrocollis
Known antibodies to botulinum toxin type A
Requirement for botulinum toxin injections to site(s) other than the neck and unable to avoid such treatment for the duration of the study
Known significant underlying swallowing or respiratory abnormality which might be exacerbated by botulinum toxin treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
Barrow Neurology Clinics at St. Joseph's Hospital and Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
The Parkinson's and Movement Disorder Institute
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
USC School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of Florida, Dept of Neurology
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
University of Miami, Dept of Neurology
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Emory University School of Medicine, Wesley Woods Health Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
University of Iowa, Dept of Neurology
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Wayne State University Medical Center
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48034
Country
United States
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12205
Country
United States
Facility Name
Beth Israel Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Columbia University Medical Center, Neurological Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
University of Texas Southwest Medical Center, Movement Disorder Clinic
City
Dallas
State/Province
Texas
ZIP/Postal Code
75309
Country
United States
Facility Name
Baylor College of Medicine, Parkinson's Disease Center and Movement Disorders Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Scientific Research Institute of Neurology, RAMS
City
Moscow
ZIP/Postal Code
123367
Country
Russian Federation
Facility Name
Clinic "Cecil Plus"
City
Moscow
ZIP/Postal Code
125047
Country
Russian Federation
Facility Name
Municipal Multi-Speciality Hospital #2
City
St Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
St Petersburg Pavlov State Medical University
City
St Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
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.
IPD Sharing Access Criteria
Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
IPD Sharing URL
https://vivli.org/members/ourmembers/
Citations:
PubMed Identifier
20359934
Citation
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.
Results Reference
result
PubMed Identifier
25324317
Citation
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.
Results Reference
derived
Learn more about this trial
Open-label Extension Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia
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