Randomized, Placebo-Controlled Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia
NCT ID: NCT00257660
Last Updated: 2022-09-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
116 participants
INTERVENTIONAL
2005-10-10
2006-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Drug: abobotulinumtoxinA (Dysport®)
Botulinum toxin type A
500 units
2
Placebo
Placebo
500 units
Interventions
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Botulinum toxin type A
500 units
Placebo
500 units
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* TWSTRS severity, disability and total scores meeting the defined criteria at baseline
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Ipsen
INDUSTRY
Responsible Party
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Principal Investigators
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Ipsen Medical Director
Role: STUDY_DIRECTOR
Ipsen
Locations
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St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
Parkinson's and Movement Disorder Institute
Fountain Valley, California, United States
USC School of Medicine
Los Angeles, California, United States
University of Florida
Gainesville, Florida, United States
University of Miami
Miami, Florida, United States
Emory University
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, 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
Albany Medical Center
Albany, New York, United States
Beth Israel Medical Center
New York, New York, United States
Columbia University
New York, New York, United States
Wake Forest University
Winston-Salem, North Carolina, United States
Allegeheny General
Pittsburgh, Pennsylvania, United States
University of Texas Southwest
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Swedish Neuroscience
Seattle, Washington, United States
Scientific Research Institute of Neurology, RAMS
Moscow, , Russia
Clinic "Cecil Plus"
Moscow, , Russia
Municipal Multi-Speciality Hospital #2
Saint Petersburg, , Russia
St Petersburg Pavlov State Medical University
Saint Petersburg, , Russia
Countries
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References
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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.
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.
Other Identifiers
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2005-000709-70
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
Y-47-52120-051
Identifier Type: -
Identifier Source: org_study_id
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