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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00288509
Other study ID # Y-47-52120-731
Secondary ID 2005-002429-29
Status Completed
Phase Phase 3
First received
Last updated
Start date February 2006
Est. completion date January 2008

Study information

Verified date September 2022
Source Ipsen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to assess longer term safety and effectiveness of Dysport®.


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date January 2008
Est. primary completion date January 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
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.

Locations

Country Name City State
Russian Federation Clinic "Cecil Plus" Moscow
Russian Federation Scientific Research Institute of Neurology, RAMS Moscow
Russian Federation Municipal Multi-Speciality Hospital #2 St Petersburg
Russian Federation St Petersburg Pavlov State Medical University St Petersburg
United States Albany Medical Center Albany New York
United States Emory University School of Medicine, Wesley Woods Health Center Atlanta Georgia
United States University of Texas Southwest Medical Center, Movement Disorder Clinic Dallas Texas
United States The Parkinson's and Movement Disorder Institute Fountain Valley California
United States University of Florida, Dept of Neurology Gainesville Florida
United States Baylor College of Medicine, Parkinson's Disease Center and Movement Disorders Clinic Houston Texas
United States University of Iowa, Dept of Neurology Iowa City Iowa
United States USC School of Medicine Los Angeles California
United States University of Miami, Dept of Neurology Miami Florida
United States Beth Israel Medical Center New York New York
United States Columbia University Medical Center, Neurological Institute New York New York
United States Barrow Neurology Clinics at St. Joseph's Hospital and Medical Center Phoenix Arizona
United States Allegheny General Hospital Pittsburgh Pennsylvania
United States Wayne State University Medical Center Southfield Michigan

Sponsors (1)

Lead Sponsor Collaborator
Ipsen

Countries where clinical trial is conducted

United States,  Russian Federation, 

References & Publications (1)

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; — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Week 4 follow-up visit
Secondary 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. Week 4 follow-up visit
Secondary 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. Week 4 follow-up visit
Secondary 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. Week 4 follow-up visit
See also
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