Trial record 1 of 2 for:    A-TL-52120-169
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A Randomised Placebo-Controlled Study Evaluating the Efficacy and Safety of DYSPORT Using 2mL Dilution in Adults With Cervical Dystonia (CD).

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Ipsen
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01753310
First received: December 17, 2012
Last updated: August 21, 2014
Last verified: August 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 ]

Estimated Enrollment: 132
Study Start Date: January 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 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

Contacts
Contact: Ipsen Recruitment Enquiries clinical.trials@ipsen.com

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
United States, Arizona
Movement Disorders Center of Arizona, LLC Recruiting
Scottsdale, Arizona, United States, 85258
University of Arizona Recruiting
Tucson, Arizona, United States, 85724
United States, California
East Bay Physician's Group Recruiting
Berkeley, California, United States, 94705
Parkinson's and Movement Disorder Institute Recruiting
Fountain Valley, California, United States, 92708
Loma Linda University Healthcare, Department of Neurology Recruiting
Loma Linda, California, United States, 92354
USC Keck School of Medicine Recruiting
Los Angeles, California, United States, 90033
Sutter Cancer Center Withdrawn
Sacramento, California, United States, 95816
UC Davis Medical Center Recruiting
Sacramento, California, United States, 95817
United States, Colorado
University of Colorado at Denver Health Sciences Recruiting
Aurora, Colorado, United States, 80045
Advanced Neurosciences Research Terminated
Fort Collins, Colorado, United States, 80528
United States, Connecticut
Associated Neurologists of Southern Connecticut Terminated
Fairfield, Connecticut, United States, 06824
Yale Medical Group, Yale University Withdrawn
New Haven, Connecticut, United States, 06520
United States, District of Columbia
Georgetown University Hospital Recruiting
Washington, District of Columbia, United States, 20007
United States, Florida
Parkinson's & Movement Disorders Center of Boca Raton Recruiting
Boca Raton, Florida, United States, 33486
University of Florida Center for Movement Disorders and Neurorestoration Recruiting
Gainesville, Florida, United States, 32607
Emerald Coast Center for Neurological Disorders Recruiting
Pensacola, Florida, United States, 32514
PD Treatment Center of SW FL Recruiting
Port Charlotte, Florida, United States, 33980
University of South Florida Recruiting
Tampa, Florida, United States, 33606
Guilford Neurologic Associates Recruiting
West Palm Beach, Florida, United States, 33407
Premiere Research Institute at Palm Beach Neurology Recruiting
West Palm Beach, Florida, United States, 33407
United States, Georgia
NeuroTrials Research Inc. Recruiting
Atlanta, Georgia, United States, 30342
Emory University Recruiting
Atlanta, Georgia, United States, 30329
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
United States, Kansas
Kansas City Bone & Joint Clinic Recruiting
Kansas City, Kansas, United States, 66211
International Clinical Research Institute Recruiting
Overland Park, Kansas, United States, 66210
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Massachusetts General Hospital Withdrawn
Boston, Massachusetts, United States, 02114
United States, Minnesota
Rehabilitation Consultants PA Recruiting
Eagan, Minnesota, United States, 55122
United States, New Jersey
University of Medicine and Dentistry of New Jersey Recruiting
Stratford, New Jersey, United States, 08084
Atlantic Neuroscience Institute Recruiting
Summit, New Jersey, United States, 07901
United States, New York
Kingston Neurological Associates Recruiting
Kingston, New York, United States, 12401
The Ichan School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Fazzini Parkinson's Disease & Dystonia Center Recruiting
New York, New York, United States
Island Neurological Associates Recruiting
Plainview, New York, United States, 11803
United States, North Carolina
Guilford Neurologic Associates; Cone Health Medical Group Recruiting
Greensboro, North Carolina, United States, 27405
Wake Forest School of Medicine Recruiting
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
University of Cincinnati Physicians Company, LLC Recruiting
Cincinnati, Ohio, United States, 45267
United States, Oregon
OHSU Center for Health and Healing Recruiting
Portland, Oregon, United States, 97239
United States, Pennsylvania
Penn State Hershey Neurology Recruiting
Hershey, Pennsylvania, United States, 17033
United States, South Carolina
Coastal Neurology Recruiting
Port Royal, South Carolina, United States, 29935
United States, Texas
North Texas Movement Disorders Institute Recruiting
Bedford, Texas, United States, 76201
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
United States, Washington
Puget Sound Neurology Recruiting
Tacoma, Washington, United States, 98409
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Kathleen G Lomax, 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: August 21, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 18, 2014