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

November 4, 2020 updated by: Ipsen

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Proportion of treatment responders using the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) severity scale score
Time Frame: Cycle 1 - Baseline and week 4
Cycle 1 - Baseline and week 4
Patient Global Impression of Change using the 7-point Likert scale
Time Frame: Cycle 1 - Baseline and week 4
Cycle 1 - Baseline and week 4

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Clinical Global Impression of Change using the 7-point Likert scale
Time Frame: Cycle 1 - Week 4 and early termination visit
Cycle 1 - Week 4 and early termination visit
Patient Global Impression of Change using the 7-point Likert scale
Time Frame: Cycle 1 - Week 4; Cycles 2 to 4 - Baseline, week 4 and termination visits
Cycle 1 - Week 4; Cycles 2 to 4 - Baseline, week 4 and termination visits
Time to Waning Effect of Dysport treatment/symptom re-emergence
Time Frame: Cycles 1 to 4 - Week 8 and at study termination visits
Cycles 1 to 4 - Week 8 and at study termination visits
Patient-self-administered questionnaire (Cervical Dystonia Impact Profile-58)
Time Frame: Cycles 1 & 3: Baseline
Cycles 1 & 3: Baseline
Patient-reported assessment of pain using the Pain Numeric Rating Scale (NRS)
Time Frame: Cycles 1 to 4 - Baseline, week 4 and at study termination visits
Cycles 1 to 4 - Baseline, week 4 and at study termination visits
Treatment Satisfaction Questionnaire for Medication (TSQM)
Time Frame: Cycle 1 - Week 4; Cycles 2 to 4 - Baseline, week 4 and termination visit
Cycle 1 - Week 4; Cycles 2 to 4 - Baseline, week 4 and termination visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ipsen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 14, 2011

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A-TL-52120-156

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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