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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01753310
First Posted: December 20, 2012
Last Update Posted: March 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ipsen
  Purpose
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.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 at Week 4. [ Time Frame: 4 weeks post-treatment ]
    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.


Secondary Outcome Measures:
  • Change From Baseline in TWSTRS Total Score at Week 2. [ Time Frame: 2 weeks post-treatment ]
    The change from baseline in the TWSTRS total score at Week 2 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.

  • Change From Baseline in Clinical Global Impression of Change (CGIC) in CD at Week 2. [ Time Frame: 2 weeks post-treatment ]
    The CGIC is an investigator-reported assessment of the global clinical change in CD since study treatment administration. The CGIC uses a seven-point Likert scale ranging from +3 (very much improved) to -3 (very much worse), and was assessed by the investigator at the Week 2 and Week 4 visits.

  • TWSTRS Responders at Week 2. [ Time Frame: 2 weeks post-treatment ]
    Treatment response was determined as the number of responders at Week 2 relative to the baseline TWSTRS total score. A treatment responder is defined as a subject who had at least a 30% reduction in the TWSTRS total score after treatment. This was calculated as ([Week 2 score - baseline score]/baseline score) * 100.

  • Change From Baseline in CGIC in CD at Week 4. [ Time Frame: 4 weeks post-treatment ]
    The CGIC is an investigator-reported assessment of the global clinical change in CD since study treatment administration. The CGIC uses a seven-point Likert scale ranging from +3 (very much improved) to -3 (very much worse), and was assessed by the investigator at the Week 2 and Week 4 visits.

  • TWSTRS Responders at Week 4. [ Time Frame: 4 weeks post-treatment ]
    Treatment response was determined as the number of responders at Week 4 relative to the baseline TWSTRS total score. A treatment responder is defined as a subject who had at least a 30% reduction in the TWSTRS total score after treatment. This was calculated as ([Week 4 score - baseline score]/baseline score) * 100.

  • Change From Baseline in Cervical Dystonia Impact Profile-58 (CDIP-58) Total Score at Week 4. [ Time Frame: 4 weeks post-treatment ]
    The CDIP-58 scale is a subject-based rating scale measuring the health impact of CD measured in 8 health dimensions including head and neck symptoms, pain and discomfort, upper limb activities, walking, sleep, annoyance, mood and psychosocial functioning. Subscale scores were transformed to a common theoretical range of 0 (no impact) to 100 (most impact). Negative changes from the baseline total score indicate improvement in the impact of CD on health whereas postive changes indicate worsening.

  • Change From Baseline in CDIP-58 Total Score at Week 2. [ Time Frame: 2 weeks post-treatment ]
    The CDIP-58 scale is a subject-based rating scale measuring the health impact of CD measured in 8 health dimensions including head and neck symptoms, pain and discomfort, upper limb activities, walking, sleep, annoyance, mood and psychosocial functioning. Subscale scores were transformed to a common theoretical range of 0 (no impact) to 100 (most impact). Negative changes from the baseline total score indicate improvement in the impact of CD on health whereas postive changes indicate worsening. The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint (change from baseline in CDIP-58 total score at Week 4) reached a statistically significant treatment effect. This secondary efficacy endpoint (change from baseline in CDIP-58 total score at Week 2) was performed to characterise the full clinical effect.


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
Other Name: AbobotulinumtoxinA (non-proprietary name)
Placebo Comparator: Placebo
Placebo, up to 2mL
Drug: Placebo
Up to 2mL

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01753310


  Hide Study Locations
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
Ipsen
Investigators
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
First Submitted: December 17, 2012
First Posted: December 20, 2012
Results First Submitted: November 8, 2016
Results First Posted: March 16, 2017
Last Update Posted: March 16, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Torticollis
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
abobotulinumtoxinA
Botulinum Toxins, Type A
onabotulinumtoxinA
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