DYSPORT™ Clinical & Health Economics Outcomes Registry in Cervical Dystonia

Cervical Dystonia Clinical Trial

— ANCHOR-CD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01314365
• Other study ID #: A-TL-52120-156
• Status: Completed
• Start date: April 2011
• Est. completion date: March 2014

Study information

• Verified date: November 2020
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: March 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Dystonia
• Dystonia
• Dystonic Disorders
• Torticollis

Locations

Country	Name	City	State
United States	The Neuro Medical Center	Baton Rouge	Louisiana
United States	East Bay Physicians Medical Group	Berkeley	California
United States	Neurology Offices of South Florida	Boca Raton	Florida
United States	Parkinson's Disease and Movement Disorders Center of Boca Raton	Boca Raton	Florida
United States	Elks Rehab Hospital - Movement Disorders Center	Boise	Idaho
United States	Rush University Medical Center Department of Neurological Sciences	Chicago	Illinois
United States	Riverhills Neuroscience	Cincinnati	Ohio
United States	University Neurology, Inc.	Cincinnati	Ohio
United States	Cleveland Clinic Center for Neurological Restoration	Cleveland	Ohio
United States	Colorado Springs Neurological Associates	Colorado Springs	Colorado
United States	University of Colorado Denver	Denver	Colorado
United States	Rehabilitation Consultants, PA	Eagan	Minnesota
United States	Headache Center	Encinitas	California
United States	The Parkinson's & Movement Disorder Institute	Fountain Valley	California
United States	Neuro-Pain Medical Center	Fresno	California
United States	Capital Neurology Services & MS Institute	Gahanna	Ohio
United States	Infinity Clinical Research, LLC	Hollywood	Florida
United States	Columbia Pain Management, PC	Hood River	Oregon
United States	Methodist Rehabilitation Center	Jackson	Mississippi
United States	Evergreen Hospital Medical Center/Booth Gardner Parkinson's Care Center	Kirkland	Washington
United States	Gundersen Clinic, Ltd.	La Crosse	Wisconsin
United States	Coastal Neurological Medical Group, Inc.	La Jolla	California
United States	Empire Neurology PC, the MS Center of Northeastern New York	Latham	New York
United States	Baptist Neurology Center - Lexington	Lexington	Kentucky
United States	Valley Parkinson Clinic	Los Gatos	California
United States	University of Miami, Dept. of Movement Disorders Clinic	Miami	Florida
United States	Palm Beach Gardens Medical Center	North Palm Beach	Florida
United States	Kansas City Bone & Joint Clinic, PA Overland Park	Overland Park	Kansas
United States	Emerald Coast Center for Neurological Disorders	Pensacola	Florida
United States	Allegheny General Hospital_Department of Neurology	Pittsburgh	Pennsylvania
United States	Parkinson's Treatment Center of SW Florida	Port Charlotte	Florida
United States	Coastal Neurology, PA	Port Royal	South Carolina
United States	Raleigh Neurology Associates	Raleigh	North Carolina
United States	Harvinder S. Birk	Redding	California
United States	University of Nevada School of Medicine	Reno	Nevada
United States	Neurology Center of San Antonio	San Antonio	Texas
United States	Victorium Clinical Research	San Antonio	Texas
United States	Arizona Dystonia Institute	Scottsdale	Arizona
United States	The Parkinson's and Movement Disorders Center	Southfield	Michigan
United States	South Puget Sound Neurology	Tacoma	Washington
United States	USF HealthParkinson's Disease and Movement Disorders Center	Tampa	Florida
United States	Neurological Associates of Tulsa	Tulsa	Oklahoma
United States	Gershon Pain Specialists	Virginia Beach	Virginia
United States	Georgetown University Hospital	Washington	District of Columbia
United States	Cleveland Clinic Florida	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of treatment responders using the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) severity scale score		Cycle 1 - Baseline and week 4
Primary	Patient Global Impression of Change using the 7-point Likert scale		Cycle 1 - Baseline and week 4
Secondary	Clinical Global Impression of Change using the 7-point Likert scale		Cycle 1 - Week 4 and early termination visit
Secondary	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
Secondary	Time to Waning Effect of Dysport treatment/symptom re-emergence		Cycles 1 to 4 - Week 8 and at study termination visits
Secondary	Patient-self-administered questionnaire (Cervical Dystonia Impact Profile-58)		Cycles 1 & 3: Baseline
Secondary	Patient-reported assessment of pain using the Pain Numeric Rating Scale (NRS)		Cycles 1 to 4 - Baseline, week 4 and at study termination visits
Secondary	Treatment Satisfaction Questionnaire for Medication (TSQM)		Cycle 1 - Week 4; Cycles 2 to 4 - Baseline, week 4 and termination visit