Randomized, Placebo-Controlled Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia
A Phase III Multicentre, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Dysport® for the Treatment of Cervical Dystonia
2 other identifiers
interventional
116
2 countries
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2005
Shorter than P25 for phase_3
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 10, 2005
CompletedFirst Submitted
Initial submission to the registry
November 22, 2005
CompletedFirst Posted
Study publicly available on registry
November 23, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedResults Posted
Study results publicly available
May 10, 2010
CompletedSeptember 28, 2022
September 1, 2022
11 months
November 22, 2005
January 6, 2010
September 15, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
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. The change in TWSTRS total score is the score at week 4 minus the score at baseline.
Baseline and Week 4
Secondary Outcomes (11)
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
Baseline and Week 8
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score
Baseline and Week 12
Subject Visual Analogue Score (VAS) for Cervical Dystonia (CD) Symptom Assessment
Baseline and Week 4
Investigator VAS for CD Symptom Assessment
Baseline and Week 4
Subject VAS for CD Symptom Assessment
Baseline and Week 8
- +6 more secondary outcomes
Study Arms (2)
1
EXPERIMENTALDrug: abobotulinumtoxinA (Dysport®)
2
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (22)
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
Parkinson's and Movement Disorder Institute
Fountain Valley, California, United States
USC School of Medicine
Los Angeles, California, 90033, United States
University of Florida
Gainesville, Florida, United States
University of Miami
Miami, Florida, United States
Emory University
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
University of Maryland Medical Center
Baltimore, Maryland, 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, 10003, United States
Columbia University
New York, New York, United States
Wake Forest University
Winston-Salem, North Carolina, United States
Allegeheny General
Pittsburgh, Pennsylvania, United States
University of Texas Southwest
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Swedish Neuroscience
Seattle, Washington, United States
Scientific Research Institute of Neurology, RAMS
Moscow, 123367, Russia
Clinic "Cecil Plus"
Moscow, 125047, Russia
Municipal Multi-Speciality Hospital #2
Saint Petersburg, 194354, Russia
St Petersburg Pavlov State Medical University
Saint Petersburg, 197022, Russia
Related Publications (2)
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.
PMID: 20359934RESULTMordin 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.
PMID: 25324317DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Director, Medical Development, Neurology
- Organization
- Ipsen
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 22, 2005
First Posted
November 23, 2005
Study Start
October 10, 2005
Primary Completion
September 1, 2006
Study Completion
September 1, 2006
Last Updated
September 28, 2022
Results First Posted
May 10, 2010
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
- Access Criteria
- Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.