DYSPORT™ Clinical & Health Economics Outcomes Registry in Cervical Dystonia

NCT ID: NCT01314365

Last Updated: 2020-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-30

Study Completion Date

2014-03-31

Brief Summary

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

Detailed Description

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Conditions

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Cervical Dystonia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ipsen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ipsen Study Director

Role: STUDY_DIRECTOR

Ipsen

Locations

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Arizona Dystonia Institute

Scottsdale, Arizona, United States

Site Status

East Bay Physicians Medical Group

Berkeley, California, United States

Site Status

Headache Center

Encinitas, California, United States

Site Status

The Parkinson's & Movement Disorder Institute

Fountain Valley, California, United States

Site Status

Neuro-Pain Medical Center

Fresno, California, United States

Site Status

Coastal Neurological Medical Group, Inc.

La Jolla, California, United States

Site Status

Valley Parkinson Clinic

Los Gatos, California, United States

Site Status

Harvinder S. Birk

Redding, California, United States

Site Status

Colorado Springs Neurological Associates

Colorado Springs, Colorado, United States

Site Status

University of Colorado Denver

Denver, Colorado, United States

Site Status

Georgetown University Hospital

Washington D.C., District of Columbia, United States

Site Status

Neurology Offices of South Florida

Boca Raton, Florida, United States

Site Status

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, United States

Site Status

Infinity Clinical Research, LLC

Hollywood, Florida, United States

Site Status

University of Miami, Dept. of Movement Disorders Clinic

Miami, Florida, United States

Site Status

Palm Beach Gardens Medical Center

North Palm Beach, Florida, United States

Site Status

Emerald Coast Center for Neurological Disorders

Pensacola, Florida, United States

Site Status

Parkinson's Treatment Center of SW Florida

Port Charlotte, Florida, United States

Site Status

USF HealthParkinson's Disease and Movement Disorders Center

Tampa, Florida, United States

Site Status

Cleveland Clinic Florida

Weston, Florida, United States

Site Status

Elks Rehab Hospital - Movement Disorders Center

Boise, Idaho, United States

Site Status

Rush University Medical Center Department of Neurological Sciences

Chicago, Illinois, United States

Site Status

Kansas City Bone & Joint Clinic, PA Overland Park

Overland Park, Kansas, United States

Site Status

Baptist Neurology Center - Lexington

Lexington, Kentucky, United States

Site Status

The Neuro Medical Center

Baton Rouge, Louisiana, United States

Site Status

The Parkinson's and Movement Disorders Center

Southfield, Michigan, United States

Site Status

Rehabilitation Consultants, PA

Eagan, Minnesota, United States

Site Status

Methodist Rehabilitation Center

Jackson, Mississippi, United States

Site Status

University of Nevada School of Medicine

Reno, Nevada, United States

Site Status

Empire Neurology PC, the MS Center of Northeastern New York

Latham, New York, United States

Site Status

Raleigh Neurology Associates

Raleigh, North Carolina, United States

Site Status

Riverhills Neuroscience

Cincinnati, Ohio, United States

Site Status

University Neurology, Inc.

Cincinnati, Ohio, United States

Site Status

Cleveland Clinic Center for Neurological Restoration

Cleveland, Ohio, United States

Site Status

Capital Neurology Services & MS Institute

Gahanna, Ohio, United States

Site Status

Neurological Associates of Tulsa

Tulsa, Oklahoma, United States

Site Status

Columbia Pain Management, PC

Hood River, Oregon, United States

Site Status

Allegheny General Hospital_Department of Neurology

Pittsburgh, Pennsylvania, United States

Site Status

Coastal Neurology, PA

Port Royal, South Carolina, United States

Site Status

Victorium Clinical Research

San Antonio, Texas, United States

Site Status

Neurology Center of San Antonio

San Antonio, Texas, United States

Site Status

Gershon Pain Specialists

Virginia Beach, Virginia, United States

Site Status

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

Kirkland, Washington, United States

Site Status

South Puget Sound Neurology

Tacoma, Washington, United States

Site Status

Gundersen Clinic, Ltd.

La Crosse, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34316644 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29530726 (View on PubMed)

Other Identifiers

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A-TL-52120-156

Identifier Type: -

Identifier Source: org_study_id