Open-label Extension Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia

Cervical Dystonia Clinical Trial

Official title:

A Phase III, Prospective, Multicenter, Open-label Extension Study to Assess the Longer Term Safety and Efficacy of Repeated Treatment of Dysport® Intramuscular Injection in the Treatment of Cervical Dystonia

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
• Start date: February 2006
• Est. completion date: January 2008

Study information

• Verified date: September 2022
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• 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

Related Conditions & MeSH terms

• Cervical Dystonia
• Dystonia
• Dystonic Disorders
• Torticollis

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