Randomized, Placebo-Controlled Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia
- Conditions
- Cervical Dystonia
- Interventions
- Biological: Botulinum toxin type ADrug: Placebo
- Registration Number
- NCT00257660
- Lead Sponsor
- Ipsen
- Brief Summary
The aim of this study is to demonstrate the effectiveness and safety of 500 units of Dysport manufactured at a new manufacturing facility in Europe.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 116
- Cervical dystonia with at least 18 months since onset, and previously untreated with botulinum toxin or previously treated with botulinum toxin type A or B with a minimum interval of 16 weeks since the last injection and having returned at least to their usual pre-treatment status
- TWSTRS severity, disability and total scores meeting the defined criteria at baseline
- Pure anterocollis or pure retrocollis
- In apparent remission from cervical dystonia
- Previous poor response to the last two botulinum toxin type A or type B treatments
- Being treated with type B toxin due to lack of efficacy to type A toxin or have known neutralizing antibodies to type A toxin
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Botulinum toxin type A Drug: abobotulinumtoxinA (Dysport®) 2 Placebo Placebo
- Primary Outcome Measures
Name Time Method Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Baseline and Week 4 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. The change in TWSTRS total score is the score at week 4 minus the score at baseline.
- Secondary Outcome Measures
Name Time Method Subject VAS for CD Symptom Assessment Baseline and week 12 The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).
SF-36 Physical Health Summary Score Week 8 SF-36 is a Quality of Life scale comprising eight individual domains. The QoL score for each domain is on a scale from 0 (worst health possible) to 100 (best health possible). SF-36 Physical Health Summary Score is derived from four individual domains (physical functioning, role physical, bodily pain and general health).
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score Baseline and Week 12 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. The change in TWSTRS total score is the score at week 4 minus the score at baseline.
Subject Visual Analogue Score (VAS) for Cervical Dystonia (CD) Symptom Assessment Baseline and Week 4 The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).
Investigator VAS for CD Symptom Assessment Baseline and Week 4 The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).
Investigator's VAS for CD Symptom Assessment Baseline and week 12 The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms) to 100 mm (worst possible symptoms).
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Baseline and Week 8 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. The change in TWSTRS total score is the score at week 4 minus the score at baseline.
SF-36 Mental Health Summary Score Week 8 SF-36 is a Quality of Life scale comprising eight individual domains. The QoL score for each domain is on a scale from 0 (worst health possible) to 100 (best health possible). SF-36 Mental Health Summary Score is derived from four individual domains (vitality, social functioning, role limitations due to emotional problems and mental health).
Number of Participants Considered by the Investigator to be Overall Treatment Successes Week 12 The number of participants considered to be overall treatment successes by the investigator at week 12 was assessed.
Trial Locations
- Locations (22)
Parkinson's and Movement Disorder Institute
🇺🇸Fountain Valley, California, United States
USC School of Medicine
🇺🇸Los Angeles, California, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
University of Miami
🇺🇸Miami, Florida, United States
Beth Israel Medical Center
🇺🇸New York, New York, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
St Petersburg Pavlov State Medical University
🇷🇺St Petersburg, Russian Federation
Allegeheny General
🇺🇸Pittsburgh, Pennsylvania, United States
Albany Medical Center
🇺🇸Albany, New York, United States
Scientific Research Institute of Neurology, RAMS
🇷🇺Moscow, Russian Federation
Clinic "Cecil Plus"
🇷🇺Moscow, Russian Federation
Columbia University
🇺🇸New York, New York, United States
St. Joseph's Hospital and Medical Center
🇺🇸Phoenix, Arizona, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Emory University
🇺🇸Atlanta, Georgia, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Wayne State University Medical Center
🇺🇸Southfield, Michigan, United States
University of Texas Southwest
🇺🇸Dallas, Texas, United States
Municipal Multi-Speciality Hospital #2
🇷🇺St Petersburg, Russian Federation
Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Swedish Neuroscience
🇺🇸Seattle, Washington, United States