DYSPORT™ Clinical & Health Economics Outcomes Registry in Cervical Dystonia (ANCHOR-CD)

DYSPORT™ for Injection AbobotulinumtoxinA Neurotoxin Clinical & Health Economics Outcomes Registry in Cervical Dystonia (ANCHOR-CD)

The purpose of the protocol is to determine typical patient response to Dysport in the treatment of adult cervical dystonia (CD).

Study Overview

• Status: Completed
• Conditions: Cervical Dystonia

• Study Type: Observational
• Enrollment (Actual): 350

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • Arizona Dystonia Institute
  • California
    • Berkeley, California, United States, 94705
      • East Bay Physicians Medical Group
    • Encinitas, California, United States, 92024
      • Headache Center
    • Fountain Valley, California, United States, 92708
      • The Parkinson's & Movement Disorder Institute
    • Fresno, California, United States, 93710
      • Neuro-Pain Medical Center
    • La Jolla, California, United States, 92037
      • Coastal Neurological Medical Group, Inc.
    • Los Gatos, California, United States, 95032
      • Valley Parkinson Clinic
    • Redding, California, United States, 96001
      • Harvinder S. Birk
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Colorado Springs Neurological Associates
    • Denver, Colorado, United States, 80045
      • University of Colorado Denver
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Georgetown University Hospital
  • Florida
    • Boca Raton, Florida, United States, 33428
      • Neurology Offices of South Florida
    • Boca Raton, Florida, United States, 33486
      • Parkinson's Disease and Movement Disorders Center of Boca Raton
    • Hollywood, Florida, United States, 33021
      • Infinity Clinical Research, LLC
    • Miami, Florida, United States, 33136
      • University of Miami, Dept. of Movement Disorders Clinic
    • North Palm Beach, Florida, United States, 33408
      • Palm Beach Gardens Medical Center
    • Pensacola, Florida, United States, 32514
      • Emerald Coast Center For Neurological Disorders
    • Port Charlotte, Florida, United States, 33980
      • Parkinson's Treatment Center of SW Florida
    • Tampa, Florida, United States, 33613
      • USF HealthParkinson's Disease and Movement Disorders Center
    • Weston, Florida, United States, 33331
      • Cleveland Clinic Florida
  • Idaho
    • Boise, Idaho, United States, 83702
      • Elks Rehab Hospital - Movement Disorders Center
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center Department of Neurological Sciences
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Kansas City Bone & Joint Clinic, PA Overland Park
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Baptist Neurology Center - Lexington
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70810
      • The Neuro Medical Center
  • Michigan
    • Southfield, Michigan, United States, 48034
      • The Parkinson's and Movement Disorders Center
  • Minnesota
    • Eagan, Minnesota, United States, 55121
      • Rehabilitation Consultants, PA
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • Methodist Rehabilitation Center
  • Nevada
    • Reno, Nevada, United States, 89502
      • University of Nevada School of Medicine
  • New York
    • Latham, New York, United States, 12110
      • Empire Neurology PC, the MS Center of Northeastern New York
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • Raleigh Neurology Associates
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Riverhills Neuroscience
    • Cincinnati, Ohio, United States, 45267
      • University Neurology, Inc.
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Center for Neurological Restoration
    • Gahanna, Ohio, United States, 43230
      • Capital Neurology Services & MS Institute
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74137
      • Neurological Associates of Tulsa
  • Oregon
    • Hood River, Oregon, United States, 97031
      • Columbia Pain Management, PC
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital_Department of Neurology
  • South Carolina
    • Port Royal, South Carolina, United States, 29935
      • Coastal Neurology, PA
  • Texas
    • San Antonio, Texas, United States, 78258
      • Neurology Center of San Antonio
    • San Antonio, Texas, United States, 78229
      • Victorium Clinical Research
  • Virginia
    • Virginia Beach, Virginia, United States, 23454
      • Gershon Pain Specialists
  • Washington
    • Kirkland, Washington, United States, 98034
      • Evergreen Hospital Medical Center/Booth Gardner Parkinson's Care Center
    • Tacoma, Washington, United States, 98405
      • South Puget Sound Neurology
  • Wisconsin
    • La Crosse, Wisconsin, United States, 54601
      • Gundersen Clinic, Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with Cervical Dystonia treated with Dysport

Description

Inclusion Criteria:

• A diagnosis of idiopathic CD as determined by the enrolling investigator
• If previously treated with a neurotoxin for CD, at least a 12-week interval must have elapsed between the last injection of Botulinum toxin A (BoNT-A) or Botulinum toxin B (BoNT-B) and the first dose of Dysport injected in this study
• Patient is able to comply with the protocol (e.g., can visit the clinic as required and can complete questionnaires/telephone interviews)
• Provision of written informed consent prior to enrollment

Exclusion Criteria:

• Contraindications to treatment with any BoNT-A or BoNT-B preparations
• Based on Investigator opinion, patients in whom previous BoNT-A or BoNT-B therapy has failed to produce a clinical response or produced an intolerable adverse reaction
• Anticipated concomitant treatment with BoNT for other than cervical dystonia
• Secondary cervical dystonia

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of treatment responders using the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) severity scale score	Cycle 1 - Baseline and week 4
Patient Global Impression of Change using the 7-point Likert scale	Cycle 1 - Baseline and week 4

Secondary Outcome Measures

Outcome Measure	Time Frame
Clinical Global Impression of Change using the 7-point Likert scale	Cycle 1 - Week 4 and early termination visit
Patient Global Impression of Change using the 7-point Likert scale	Cycle 1 - Week 4; Cycles 2 to 4 - Baseline, week 4 and termination visits
Time to Waning Effect of Dysport treatment/symptom re-emergence	Cycles 1 to 4 - Week 8 and at study termination visits
Patient-self-administered questionnaire (Cervical Dystonia Impact Profile-58)	Cycles 1 & 3: Baseline
Patient-reported assessment of pain using the Pain Numeric Rating Scale (NRS)	Cycles 1 to 4 - Baseline, week 4 and at study termination visits
Treatment Satisfaction Questionnaire for Medication (TSQM)	Cycle 1 - Week 4; Cycles 2 to 4 - Baseline, week 4 and termination visit

Collaborators and Investigators

• Sponsor: Ipsen

Publications and helpful links

General Publications

• Trosch RM, Misra VP, Maisonobe P, Om S. Impact of abobotulinumtoxinA on the clinical features of cervical dystonia in routine practice. Clin Park Relat Disord. 2020 Jun 15;3:100063. doi: 10.1016/j.prdoa.2020.100063. eCollection 2020.
• Espay AJ, Trosch R, Suarez G, Johnson J, Marchese D, Comella C. Minimal clinically important change in the Toronto Western Spasmodic Torticollis Rating Scale. Parkinsonism Relat Disord. 2018 Jul;52:94-97. doi: 10.1016/j.parkreldis.2018.03.002. Epub 2018 Mar 7.

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (ACTUAL): November 1, 2013
• Study Completion (ACTUAL): March 1, 2014

Study Registration Dates

• First Submitted: March 10, 2011
• First Submitted That Met QC Criteria: March 11, 2011
• First Posted (ESTIMATE): March 14, 2011

Study Record Updates

• Last Update Posted (ACTUAL): November 5, 2020
• Last Update Submitted That Met QC Criteria: November 4, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Movement Disorders; Dyskinesias; Dystonia; Dystonic Disorders; Torticollis
• Other Study ID Numbers: A-TL-52120-156