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)
1 other identifier
observational
350
1 country
45
Brief Summary
The purpose of the protocol is to determine typical patient response to Dysport in the treatment of adult cervical dystonia (CD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2011
Typical duration for all trials
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2011
CompletedFirst Posted
Study publicly available on registry
March 14, 2011
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedNovember 5, 2020
November 1, 2020
2.6 years
March 10, 2011
November 4, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (6)
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
- +1 more secondary outcomes
Eligibility Criteria
Adult patients with Cervical Dystonia treated with Dysport
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (45)
Arizona Dystonia Institute
Scottsdale, Arizona, 85258, United States
East Bay Physicians Medical Group
Berkeley, California, 94705, United States
Headache Center
Encinitas, California, 92024, United States
The Parkinson's & Movement Disorder Institute
Fountain Valley, California, 92708, United States
Neuro-Pain Medical Center
Fresno, California, 93710, United States
Coastal Neurological Medical Group, Inc.
La Jolla, California, 92037, United States
Valley Parkinson Clinic
Los Gatos, California, 95032, United States
Harvinder S. Birk
Redding, California, 96001, United States
Colorado Springs Neurological Associates
Colorado Springs, Colorado, 80907, United States
University of Colorado Denver
Denver, Colorado, 80045, United States
Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Neurology Offices of South Florida
Boca Raton, Florida, 33428, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33486, United States
Infinity Clinical Research, LLC
Hollywood, Florida, 33021, United States
University of Miami, Dept. of Movement Disorders Clinic
Miami, Florida, 33136, United States
Palm Beach Gardens Medical Center
North Palm Beach, Florida, 33408, United States
Emerald Coast Center for Neurological Disorders
Pensacola, Florida, 32514, United States
Parkinson's Treatment Center of SW Florida
Port Charlotte, Florida, 33980, United States
USF HealthParkinson's Disease and Movement Disorders Center
Tampa, Florida, 33613, United States
Cleveland Clinic Florida
Weston, Florida, 33331, United States
Elks Rehab Hospital - Movement Disorders Center
Boise, Idaho, 83702, United States
Rush University Medical Center Department of Neurological Sciences
Chicago, Illinois, 60612, United States
Kansas City Bone & Joint Clinic, PA Overland Park
Overland Park, Kansas, 66211, United States
Baptist Neurology Center - Lexington
Lexington, Kentucky, 40503, United States
The Neuro Medical Center
Baton Rouge, Louisiana, 70810, United States
The Parkinson's and Movement Disorders Center
Southfield, Michigan, 48034, United States
Rehabilitation Consultants, PA
Eagan, Minnesota, 55121, United States
Methodist Rehabilitation Center
Jackson, Mississippi, 39216, United States
University of Nevada School of Medicine
Reno, Nevada, 89502, United States
Empire Neurology PC, the MS Center of Northeastern New York
Latham, New York, 12110, United States
Raleigh Neurology Associates
Raleigh, North Carolina, 27607, United States
Riverhills Neuroscience
Cincinnati, Ohio, 45219, United States
University Neurology, Inc.
Cincinnati, Ohio, 45267, United States
Cleveland Clinic Center for Neurological Restoration
Cleveland, Ohio, 44195, United States
Capital Neurology Services & MS Institute
Gahanna, Ohio, 43230, United States
Neurological Associates of Tulsa
Tulsa, Oklahoma, 74137, United States
Columbia Pain Management, PC
Hood River, Oregon, 97031, United States
Allegheny General Hospital_Department of Neurology
Pittsburgh, Pennsylvania, 15212, United States
Coastal Neurology, PA
Port Royal, South Carolina, 29935, United States
Victorium Clinical Research
San Antonio, Texas, 78229, United States
Neurology Center of San Antonio
San Antonio, Texas, 78258, United States
Gershon Pain Specialists
Virginia Beach, Virginia, 23454, United States
Evergreen Hospital Medical Center/Booth Gardner Parkinson's Care Center
Kirkland, Washington, 98034, United States
South Puget Sound Neurology
Tacoma, Washington, 98405, United States
Gundersen Clinic, Ltd.
La Crosse, Wisconsin, 54601, United States
Related Publications (2)
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.
PMID: 34316644DERIVEDEspay 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.
PMID: 29530726DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ipsen Study Director
Ipsen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2011
First Posted
March 14, 2011
Study Start
April 1, 2011
Primary Completion
November 1, 2013
Study Completion
March 1, 2014
Last Updated
November 5, 2020
Record last verified: 2020-11