Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 1 of 2 for:    A-TL-52120-169
Previous Study | Return to List | Next Study

A Randomised Placebo-Controlled Study Evaluating the Efficacy and Safety of DYSPORT Using 2mL Dilution in Adults With Cervical Dystonia (CD).

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01753310
First received: December 17, 2012
Last updated: November 3, 2014
Last verified: November 2014
  Purpose

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, Up to 2mL
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in TWSTRS total score [ Time Frame: Baseline and 2 weeks post-treatment ] [ Designated as safety issue: No ]
  • Clinical Global Impression of Change (CGIC) in Cervical Dystonia [ Time Frame: 2 and 4 weeks post-treatment ] [ Designated as safety issue: No ]
  • Treatment response [ Time Frame: 2 and 4 weeks post-treatment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Enrollment: 134
Study Start Date: January 2013
Estimated Study Completion Date: November 2014
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
Dysport (intramuscular injection), between 250 and 500 units (U)/vial using 2mL dilution, 1 cycle only
Placebo Comparator: Placebo
Up to 2mL
Drug: Placebo, Up to 2mL

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Premiere Research Institute at Palm Beach Neurology
West Palm Beach, Florida, United States, 33407
Guilford Neurologic Associates
West Palm Beach, Florida, United States, 33407
United States, Georgia
NeuroTrials Research Inc.
Atlanta, Georgia, United States, 30342
Emory University
Atlanta, Georgia, United States, 30329
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
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

No publications provided

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: November 3, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Torticollis
Central Nervous System Diseases
Dyskinesias
Movement Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014