Open-label Extension Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia
- Conditions
- Cervical Dystonia
- Interventions
- Biological: Botulinum toxin type A
- Registration Number
- NCT00288509
- Lead Sponsor
- Ipsen
- Brief Summary
The aim of this study is to assess longer term safety and effectiveness of Dysport®.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 108
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dysport Botulinum toxin type A 250-1000 units
- Primary Outcome Measures
Name Time Method Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline Week 4 follow-up visit 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
Name Time Method Toronto Western Spasmodic Torticollis Rating Scale Disability Subscale Score as a Change From Baseline Week 4 follow-up visit 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 Severity Subscale as a Change From Baseline Week 4 follow-up visit 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 Pain Subscale Score as a Change From Baseline Week 4 follow-up visit 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.
Trial Locations
- Locations (18)
University of Iowa, Dept of Neurology
🇺🇸Iowa City, Iowa, United States
Emory University School of Medicine, Wesley Woods Health Center
🇺🇸Atlanta, Georgia, United States
Albany Medical Center
🇺🇸Albany, New York, United States
Beth Israel Medical Center
🇺🇸New York, New York, United States
Columbia University Medical Center, Neurological Institute
🇺🇸New York, New York, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
University of Texas Southwest Medical Center, Movement Disorder Clinic
🇺🇸Dallas, Texas, United States
Baylor College of Medicine, Parkinson's Disease Center and Movement Disorders Clinic
🇺🇸Houston, Texas, United States
Barrow Neurology Clinics at St. Joseph's Hospital and Medical Center
🇺🇸Phoenix, Arizona, United States
The Parkinson's and Movement Disorder Institute
🇺🇸Fountain Valley, California, United States
USC School of Medicine
🇺🇸Los Angeles, California, United States
University of Florida, Dept of Neurology
🇺🇸Gainesville, Florida, United States
St Petersburg Pavlov State Medical University
🇷🇺St Petersburg, Russian Federation
University of Miami, Dept of Neurology
🇺🇸Miami, Florida, United States
Wayne State University Medical Center
🇺🇸Southfield, Michigan, United States
Scientific Research Institute of Neurology, RAMS
🇷🇺Moscow, Russian Federation
Clinic "Cecil Plus"
🇷🇺Moscow, Russian Federation
Municipal Multi-Speciality Hospital #2
🇷🇺St Petersburg, Russian Federation