Efficacy and Safety of DYSPORT Using 2mL Dilution in Adults With Cervical Dystonia.

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: December 17, 2012
Last updated: February 16, 2015
Last verified: February 2015
The purpose of the protocol is to evaluate the efficacy of Dysport using 2 mL dilution compared with placebo for the treatment of Cervical Dystonia.

Condition Intervention Phase
Cervical Dystonia
Drug: Dysport
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Change from baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score [ Time Frame: 4 weeks post-treatment ]

Secondary Outcome Measures:
  • Change from baseline in TWSTRS total score [ Time Frame: Baseline and 2 weeks post-treatment ]
  • Clinical Global Impression of Change (CGIC) in Cervical Dystonia [ Time Frame: 2 and 4 weeks post-treatment ]
  • Treatment response [ Time Frame: 2 and 4 weeks post-treatment ]
    A treatment responder is defined as a subject who had at least a 30% reduction in the TWSTRS total score after treatment.

  • Change in Cervical Dystonia Impact Profile-58 (CDIP-58) score [ Time Frame: 2 and 4 weeks post-treatment ]

Enrollment: 134
Study Start Date: January 2013
Study Completion Date: January 2015
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dysport
Dysport (intramuscular injection), between 250 and 500 units (U)/vial using 2mL dilution, 1 cycle only
Drug: Dysport
Intramuscular injection, between 250 and 500 units (U)/vial using 2mL dilution, 1 cycle only
Placebo Comparator: Placebo
Placebo, up to 2mL
Drug: Placebo
Up to 2mL


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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;

Exclusion Criteria:

  • 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01753310

  Hide Study Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Movement Disorders Center of Arizona, LLC
Scottsdale, Arizona, United States, 85258
University of Arizona
Tucson, Arizona, United States, 85724
United States, California
East Bay Physician's Group
Berkeley, California, United States, 94705
Parkinson's and Movement Disorder Institute
Fountain Valley, California, United States, 92708
Loma Linda University Healthcare, Department of Neurology
Loma Linda, California, United States, 92354
USC Keck School of Medicine
Los Angeles, California, United States, 90033
UC Davis Medical Center
Sacramento, California, United States, 95817
United States, Colorado
University of Colorado at Denver Health Sciences
Aurora, Colorado, United States, 80045
Advanced Neurosciences Research
Fort Collins, Colorado, United States, 80528
United States, Connecticut
Associated Neurologists of Southern Connecticut
Fairfield, Connecticut, United States, 06824
United States, District of Columbia
Georgetown University Hospital
Washington, District of Columbia, United States, 20007
United States, Florida
Parkinson's & Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States, 33486
University of Florida Center for Movement Disorders and Neurorestoration
Gainesville, Florida, United States, 32607
Emerald Coast Center for Neurological Disorders
Pensacola, Florida, United States, 32514
PD Treatment Center of SW FL
Port Charlotte, Florida, United States, 33980
University of South Florida
Tampa, Florida, United States, 33606
Guilford Neurologic Associates
West Palm Beach, Florida, United States, 33407
Premiere Research Institute at Palm Beach Neurology
West Palm Beach, Florida, United States, 33407
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30329
NeuroTrials Research Inc.
Atlanta, Georgia, United States, 30342
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Kansas
Kansas City Bone & Joint Clinic
Kansas City, Kansas, United States, 66211
International Clinical Research Institute
Overland Park, Kansas, United States, 66210
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
United States, Minnesota
Rehabilitation Consultants PA
Eagan, Minnesota, United States, 55122
United States, New Jersey
University of Medicine and Dentistry of New Jersey
Stratford, New Jersey, United States, 08084
Atlantic Neuroscience Institute
Summit, New Jersey, United States, 07901
United States, New York
Kingston Neurological Associates
Kingston, New York, United States, 12401
Fazzini Parkinson's Disease & Dystonia Center
New York, New York, United States, 10016
The Ichan School of Medicine at Mount Sinai
New York, New York, United States, 10029
Island Neurological Associates
Plainview, New York, United States, 11803
United States, North Carolina
Guilford Neurologic Associates; Cone Health Medical Group
Greensboro, North Carolina, United States, 27405
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
University of Cincinnati Physicians Company, LLC
Cincinnati, Ohio, United States, 45267
United States, Oregon
OHSU Center for Health and Healing
Portland, Oregon, United States, 97239
United States, Pennsylvania
Penn State Hershey Neurology
Hershey, Pennsylvania, United States, 17033
United States, South Carolina
Coastal Neurology
Port Royal, South Carolina, United States, 29935
United States, Texas
North Texas Movement Disorders Institute
Bedford, Texas, United States, 76201
Baylor College of Medicine
Houston, Texas, United States, 77030
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
United States, Washington
Puget Sound Neurology
Tacoma, Washington, United States, 98409
Sponsors and Collaborators
Study Director: Medical Director, Neurology, M.D. Ipsen
  More Information

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01753310     History of Changes
Other Study ID Numbers: A-TL-52120-169 
Study First Received: December 17, 2012
Last Updated: February 16, 2015

Additional relevant MeSH terms:
Dystonic Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on January 19, 2017