Clinical trial NCT00288509: Open-label Extension Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cervical Dystonia
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2006-02-08
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline
timeFrame: Week 4 follow-up visit
Secondary outcomes:
measure: Toronto Western Spasmodic Torticollis Rating Scale Severity Subscale as a Change From Baseline
timeFrame: Week 4 follow-up visit
measure: Toronto Western Spasmodic Torticollis Rating Scale Disability Subscale Score as a Change From Baseline
timeFrame: Week 4 follow-up visit
measure: Toronto Western Spasmodic Torticollis Rating Scale Pain Subscale Score as a Change From Baseline
timeFrame: Week 4 follow-up visit
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurology Clinics at St. Joseph's Hospital and Medical Center
state: Arizona
city: Fountain Valley
country: United States
facility: The Parkinson's and Movement Disorder Institute
state: California
city: Los Angeles
country: United States
facility: USC School of Medicine
state: California
city: Gainesville
country: United States
facility: University of Florida, Dept of Neurology
state: Florida
city: Miami
country: United States
facility: University of Miami, Dept of Neurology
state: Florida
city: Atlanta
country: United States
facility: Emory University School of Medicine, Wesley Woods Health Center
state: Georgia
city: Iowa City
country: United States
facility: University of Iowa, Dept of Neurology
state: Iowa
city: Southfield
country: United States
facility: Wayne State University Medical Center
state: Michigan
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center, Neurological Institute
state: New York
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas Southwest Medical Center, Movement Disorder Clinic
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine, Parkinson's Disease Center and Movement Disorders Clinic
state: Texas
city: Moscow
country: Russian Federation
facility: Scientific Research Institute of Neurology, RAMS
city: Moscow
country: Russian Federation
facility: Clinic "Cecil Plus"
city: St Petersburg
country: Russian Federation
facility: Municipal Multi-Speciality Hospital #2
city: St Petersburg
country: Russian Federation
facility: St Petersburg Pavlov State Medical University
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.