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Cervical DystoniaANCHOR-CDNCT01314365

DYSPORT™ Clinical & Health Economics Outcomes Registry in Cervical Dystonia

An observational study of Cervical Dystonia, run by Ipsen at 45 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Cervical Dystonia
How many people
350 participants
Where
45 sitesUnited States
Study dates
Apr 2011to Mar 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients with Cervical Dystonia treated with Dysport

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

45 sites in 1 country.

45 sites in 1 country

United States45 sites

  • The Neuro Medical Center

    Baton Rouge, Louisiana, 70810

  • East Bay Physicians Medical Group

    Berkeley, California, 94705

  • Neurology Offices of South Florida

    Boca Raton, Florida, 33428

  • Parkinson's Disease and Movement Disorders Center of Boca Raton

    Boca Raton, Florida, 33486

  • Elks Rehab Hospital - Movement Disorders Center

    Boise, Idaho, 83702

  • Rush University Medical Center Department of Neurological Sciences

    Chicago, Illinois, 60612

  • Riverhills Neuroscience

    Cincinnati, Ohio, 45219

  • University Neurology, Inc.

    Cincinnati, Ohio, 45267

  • Cleveland Clinic Center for Neurological Restoration

    Cleveland, Ohio, 44195

  • Colorado Springs Neurological Associates

    Colorado Springs, Colorado, 80907

  • University of Colorado Denver

    Denver, Colorado, 80045

  • Rehabilitation Consultants, PA

    Eagan, Minnesota, 55121

  • Headache Center

    Encinitas, California, 92024

  • The Parkinson's & Movement Disorder Institute

    Fountain Valley, California, 92708

  • Neuro-Pain Medical Center

    Fresno, California, 93710

  • Capital Neurology Services & MS Institute

    Gahanna, Ohio, 43230

  • Infinity Clinical Research, LLC

    Hollywood, Florida, 33021

  • Columbia Pain Management, PC

    Hood River, Oregon, 97031

  • Methodist Rehabilitation Center

    Jackson, Mississippi, 39216

  • Evergreen Hospital Medical Center/Booth Gardner Parkinson's Care Center

    Kirkland, Washington, 98034

  • Gundersen Clinic, Ltd.

    La Crosse, Wisconsin, 54601

  • Coastal Neurological Medical Group, Inc.

    La Jolla, California, 92037

  • Empire Neurology PC, the MS Center of Northeastern New York

    Latham, New York, 12110

  • Baptist Neurology Center - Lexington

    Lexington, Kentucky, 40503

  • Valley Parkinson Clinic

    Los Gatos, California, 95032

  • University of Miami, Dept. of Movement Disorders Clinic

    Miami, Florida, 33136

  • Palm Beach Gardens Medical Center

    North Palm Beach, Florida, 33408

  • Kansas City Bone & Joint Clinic, PA Overland Park

    Overland Park, Kansas, 66211

  • Emerald Coast Center for Neurological Disorders

    Pensacola, Florida, 32514

  • Allegheny General Hospital_Department of Neurology

    Pittsburgh, Pennsylvania, 15212

  • Parkinson's Treatment Center of SW Florida

    Port Charlotte, Florida, 33980

  • Coastal Neurology, PA

    Port Royal, South Carolina, 29935

  • Raleigh Neurology Associates

    Raleigh, North Carolina, 27607

  • Harvinder S. Birk

    Redding, California, 96001

  • University of Nevada School of Medicine

    Reno, Nevada, 89502

  • Victorium Clinical Research

    San Antonio, Texas, 78229

  • Neurology Center of San Antonio

    San Antonio, Texas, 78258

  • Arizona Dystonia Institute

    Scottsdale, Arizona, 85258

  • The Parkinson's and Movement Disorders Center

    Southfield, Michigan, 48034

  • South Puget Sound Neurology

    Tacoma, Washington, 98405

  • USF HealthParkinson's Disease and Movement Disorders Center

    Tampa, Florida, 33613

  • Neurological Associates of Tulsa

    Tulsa, Oklahoma, 74137

  • Gershon Pain Specialists

    Virginia Beach, Virginia, 23454

  • Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

  • Cleveland Clinic Florida

    Weston, Florida, 33331

Other trials in United States

About this study

Official title: 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).

Medical subject headings
Torticollis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of treatment responders using the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) severity scale score

    Measured: Cycle 1 - Baseline and week 4

  2. Patient Global Impression of Change using the 7-point Likert scale

    Measured: Cycle 1 - Baseline and week 4

Secondary outcomes (6)

  1. Clinical Global Impression of Change using the 7-point Likert scale

    Measured: Cycle 1 - Week 4 and early termination visit

  2. Patient Global Impression of Change using the 7-point Likert scale

    Measured: Cycle 1 - Week 4; Cycles 2 to 4 - Baseline, week 4 and termination visits

  3. Time to Waning Effect of Dysport treatment/symptom re-emergence

    Measured: Cycles 1 to 4 - Week 8 and at study termination visits

  4. Patient-self-administered questionnaire (Cervical Dystonia Impact Profile-58)

    Measured: Cycles 1 & 3: Baseline

  5. Patient-reported assessment of pain using the Pain Numeric Rating Scale (NRS)

    Measured: Cycles 1 to 4 - Baseline, week 4 and at study termination visits

  6. Treatment Satisfaction Questionnaire for Medication (TSQM)

    Measured: Cycle 1 - Week 4; Cycles 2 to 4 - Baseline, week 4 and termination visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2011 (estimated)
  2. Study startApr 2011
  3. Primary completionNov 2013
  4. Study completionMar 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
350 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01314365
Sponsor's protocol ID
A-TL-52120-156
Acronym
ANCHOR-CD
Status last verified
Nov 2020
First submitted
10 Mar 2011
Last updated
5 Nov 2020
Results posted
No
Data monitoring committee
No

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.

    PubMed 34316644

  • 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.

    PubMed 29530726

Questions about this trial

What is this clinical trial studying?

An observational study of Cervical Dystonia, run by Ipsen at 45 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of treatment responders using the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) severity scale score (time frame: Cycle 1 - Baseline and week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01314365, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.

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