Open-label Extension Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia
NCT ID: NCT00288509
Last Updated: 2022-09-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
108 participants
INTERVENTIONAL
2006-02-28
2008-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dysport
250-1000 units
Botulinum toxin type A
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.
Interventions
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Botulinum toxin type A
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Returned to pre-treatment status as judged by the Investigator
Exclusion Criteria
* 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
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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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
University of Miami, Dept of Neurology
Miami, Florida, United States
Emory University School of Medicine, Wesley Woods Health Center
Atlanta, Georgia, United States
University of Iowa, Dept of Neurology
Iowa City, Iowa, 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 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
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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2005-002429-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
Y-47-52120-731
Identifier Type: -
Identifier Source: org_study_id
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