Efficacy and Safety of DYSPORT® Using 2mL Dilution in Adults With Cervical Dystonia.
A Phase 3b, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of DYSPORT® Using 2mL Dilution in Adults With Cervical Dystonia.
1 other identifier
interventional
134
1 country
42
Brief Summary
The purpose of the protocol is to evaluate the efficacy and safety of Dysport® using 2 mL dilution compared with placebo for the treatment of Cervical Dystonia.
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 Jan 2013
42 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
First Submitted
Initial submission to the registry
December 17, 2012
CompletedFirst Posted
Study publicly available on registry
December 20, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedResults Posted
Study results publicly available
March 16, 2017
CompletedAugust 7, 2019
July 1, 2019
1.7 years
December 17, 2012
November 8, 2016
July 25, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4.
The change from baseline in the TWSTRS total score at Week 4 was determined for the subjects who received a single dose of Dysport® or placebo by intramuscular injection at the baseline visit (Day 1), and is expressed as weighted overall treatment difference. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator prior to study treatment at baseline and at all post-treatment visits.
4 weeks post-treatment
Secondary Outcomes (7)
Change From Baseline in TWSTRS Total Score at Week 2.
2 weeks post-treatment
Change From Baseline in Clinical Global Impression of Change (CGIC) in CD at Week 2.
2 weeks post-treatment
TWSTRS Responders at Week 2.
2 weeks post-treatment
Change From Baseline in CGIC in CD at Week 4.
4 weeks post-treatment
TWSTRS Responders at Week 4.
4 weeks post-treatment
- +2 more secondary outcomes
Study Arms (2)
Dysport®
ACTIVE COMPARATORDysport® (intramuscular injection), between 250 and 500 units (U)/vial using 2mL dilution, 1 cycle only
Placebo
PLACEBO COMPARATORPlacebo, up to 2mL
Interventions
Intramuscular injection, between 250 and 500 units (U)/vial using 2mL dilution, 1 cycle only
Eligibility Criteria
You may qualify if:
- Primary diagnosis of Cervical Dystonia at least 9 months since onset and either previously untreated with botulinum toxin or currently treated with Botox at a total dosing range of 100-200 U and ≤60 U in the sternocleidomastoid muscle at the last injection cycle, and having had a satisfactory treatment response in the principal investigator's judgment during the last two sequential Botox treatment cycles.
- TWSTRS total score≥ 20; TWSTRS-severity subscale score\> 10;
You may not qualify if:
- In apparent remission from Cervical Dystonia
- Diagnosis of pure retrocollis or pure anterocollis
- For non-naïve subjects, previous poor response to either of the last two Botox treatments
- Known requirement of \<100U or \>200U of Botox injected into the neck muscles
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (42)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Movement Disorders Center of Arizona, LLC
Scottsdale, Arizona, 85258, United States
University of Arizona
Tucson, Arizona, 85724, United States
East Bay Physician's Group
Berkeley, California, 94705, United States
Parkinson's and Movement Disorder Institute
Fountain Valley, California, 92708, United States
Loma Linda University Healthcare, Department of Neurology
Loma Linda, California, 92354, United States
USC Keck School of Medicine
Los Angeles, California, 90033, United States
UC Davis Medical Center
Sacramento, California, 95817, United States
University of Colorado at Denver Health Sciences
Aurora, Colorado, 80045, United States
Advanced Neurosciences Research
Fort Collins, Colorado, 80528, United States
Associated Neurologists of Southern Connecticut
Fairfield, Connecticut, 06824, United States
Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Parkinson's & Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33486, United States
University of Florida Center for Movement Disorders and Neurorestoration
Gainesville, Florida, 32607, United States
Emerald Coast Center for Neurological Disorders
Pensacola, Florida, 32514, United States
PD Treatment Center of SW FL
Port Charlotte, Florida, 33980, United States
University of South Florida
Tampa, Florida, 33606, United States
Guilford Neurologic Associates
West Palm Beach, Florida, 33407, United States
Premiere Research Institute at Palm Beach Neurology
West Palm Beach, Florida, 33407, United States
Emory University
Atlanta, Georgia, 30329, United States
NeuroTrials Research Inc.
Atlanta, Georgia, 30342, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Kansas City Bone & Joint Clinic
Kansas City, Kansas, 66211, United States
International Clinical Research Institute
Overland Park, Kansas, 66210, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Rehabilitation Consultants PA
Eagan, Minnesota, 55122, United States
University of Medicine and Dentistry of New Jersey
Stratford, New Jersey, 08084, United States
Atlantic Neuroscience Institute
Summit, New Jersey, 07901, United States
Kingston Neurological Associates
Kingston, New York, 12401, United States
Fazzini Parkinson's Disease & Dystonia Center
New York, New York, 10016, United States
The Ichan School of Medicine at Mount Sinai
New York, New York, 10029, United States
Island Neurological Associates
Plainview, New York, 11803, United States
Guilford Neurologic Associates; Cone Health Medical Group
Greensboro, North Carolina, 27405, United States
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157, United States
University of Cincinnati Physicians Company, LLC
Cincinnati, Ohio, 45267, United States
OHSU Center for Health and Healing
Portland, Oregon, 97239, United States
Penn State Hershey Neurology
Hershey, Pennsylvania, 17033, United States
Coastal Neurology
Port Royal, South Carolina, 29935, United States
North Texas Movement Disorders Institute
Bedford, Texas, 76201, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Puget Sound Neurology
Tacoma, Washington, 98409, United States
Related Publications (1)
Patel AT, Lew MF, Dashtipour K, Isaacson S, Hauser RA, Ondo W, Maisonobe P, Wietek S, Rubin B, Brashear A. Sustained functional benefits after a single set of injections with abobotulinumtoxinA using a 2-mL injection volume in adults with cervical dystonia: 12-week results from a randomized, double-blind, placebo-controlled phase 3b study. PLoS One. 2021 Feb 1;16(2):e0245827. doi: 10.1371/journal.pone.0245827. eCollection 2021.
PMID: 33524060DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Ipsen Biopharmaceuticals, Inc.
Study Officials
- STUDY DIRECTOR
Medical Director, Neurology, M.D.
Ipsen
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
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
December 17, 2012
First Posted
December 20, 2012
Study Start
January 1, 2013
Primary Completion
October 1, 2014
Study Completion
January 1, 2015
Last Updated
August 7, 2019
Results First Posted
March 16, 2017
Record last verified: 2019-07