Clinical trial NCT00257660: Randomized, Placebo-Controlled Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia
Official title: A Phase III Multicentre, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Dysport® for the Treatment of Cervical Dystonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cervical Dystonia
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2005-11-23
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to demonstrate the effectiveness and safety of 500 units of Dysport manufactured at a new manufacturing facility in Europe.


Eligibility criteria: Inclusion Criteria:

* Cervical dystonia with at least 18 months since onset, and previously untreated with botulinum toxin or previously treated with botulinum toxin type A or B with a minimum interval of 16 weeks since the last injection and having returned at least to their usual pre-treatment status
* TWSTRS severity, disability and total scores meeting the defined criteria at baseline

Exclusion Criteria:

* Pure anterocollis or pure retrocollis
* 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

Primary outcomes:
measure: Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
timeFrame: Baseline and Week 4
Secondary outcomes:
measure: Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
timeFrame: Baseline and Week 8
measure: Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score
timeFrame: Baseline and Week 12
measure: Subject Visual Analogue Score (VAS) for Cervical Dystonia (CD) Symptom Assessment
timeFrame: Baseline and Week 4
measure: Investigator VAS for CD Symptom Assessment
timeFrame: Baseline and Week 4
measure: Subject VAS for CD Symptom Assessment
timeFrame: Baseline and Week 8
measure: Investigator's VAS for CD Symptom Assessment
timeFrame: Baseline and week 8
measure: Subject VAS for CD Symptom Assessment
timeFrame: Baseline and week 12
measure: Investigator's VAS for CD Symptom Assessment
timeFrame: Baseline and week 12
measure: SF-36 Mental Health Summary Score
timeFrame: Week 8
measure: SF-36 Physical Health Summary Score
timeFrame: Week 8
measure: Number of Participants Considered by the Investigator to be Overall Treatment Successes
timeFrame: Week 12
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center
state: Arizona
city: Fountain Valley
country: United States
facility: 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
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
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
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
city: Pittsburgh
country: United States
facility: Allegeheny General
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas Southwest
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Seattle
country: United States
facility: Swedish Neuroscience
state: Washington
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.