Clinical trial NCT01314365: DYSPORT™ Clinical & Health Economics Outcomes Registry in Cervical Dystonia
Official title: DYSPORT™ for Injection AbobotulinumtoxinA Neurotoxin Clinical & Health Economics Outcomes Registry in Cervical Dystonia (ANCHOR-CD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Dystonia
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2011-03-14
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with Cervical Dystonia treated with Dysport

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


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of treatment responders using the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) severity scale score
timeFrame: Cycle 1 - Baseline and week 4
measure: Patient Global Impression of Change using the 7-point Likert scale
timeFrame: Cycle 1 - Baseline and week 4
Secondary outcomes:
measure: Clinical Global Impression of Change using the 7-point Likert scale
timeFrame: Cycle 1 - Week 4 and early termination visit
measure: Patient Global Impression of Change using the 7-point Likert scale
timeFrame: Cycle 1 - Week 4; Cycles 2 to 4 - Baseline, week 4 and termination visits
measure: Time to Waning Effect of Dysport treatment/symptom re-emergence
timeFrame: Cycles 1 to 4 - Week 8 and at study termination visits
measure: Patient-self-administered questionnaire (Cervical Dystonia Impact Profile-58)
timeFrame: Cycles 1 & 3: Baseline
measure: Patient-reported assessment of pain using the Pain Numeric Rating Scale (NRS)
timeFrame: Cycles 1 to 4 - Baseline, week 4 and at study termination visits
measure: Treatment Satisfaction Questionnaire for Medication (TSQM)
timeFrame: Cycle 1 - Week 4; Cycles 2 to 4 - Baseline, week 4 and termination visit
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Arizona Dystonia Institute
state: Arizona
city: Berkeley
country: United States
facility: East Bay Physicians Medical Group
state: California
city: Encinitas
country: United States
facility: Headache Center
state: California
city: Fountain Valley
country: United States
facility: The Parkinson's & Movement Disorder Institute
state: California
city: Fresno
country: United States
facility: Neuro-Pain Medical Center
state: California
city: La Jolla
country: United States
facility: Coastal Neurological Medical Group, Inc.
state: California
city: Los Gatos
country: United States
facility: Valley Parkinson Clinic
state: California
city: Redding
country: United States
facility: Harvinder S. Birk
state: California
city: Colorado Springs
country: United States
facility: Colorado Springs Neurological Associates
state: Colorado
city: Denver
country: United States
facility: University of Colorado Denver
state: Colorado
city: Washington
country: United States
facility: Georgetown University Hospital
state: District of Columbia
city: Boca Raton
country: United States
facility: Neurology Offices of South Florida
state: Florida
city: Boca Raton
country: United States
facility: Parkinson's Disease and Movement Disorders Center of Boca Raton
state: Florida
city: Hollywood
country: United States
facility: Infinity Clinical Research, LLC
state: Florida
city: Miami
country: United States
facility: University of Miami, Dept. of Movement Disorders Clinic
state: Florida
city: North Palm Beach
country: United States
facility: Palm Beach Gardens Medical Center
state: Florida
city: Pensacola
country: United States
facility: Emerald Coast Center for Neurological Disorders
state: Florida
city: Port Charlotte
country: United States
facility: Parkinson's Treatment Center of SW Florida
state: Florida
city: Tampa
country: United States
facility: USF HealthParkinson's Disease and Movement Disorders Center
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Boise
country: United States
facility: Elks Rehab Hospital - Movement Disorders Center
state: Idaho
city: Chicago
country: United States
facility: Rush University Medical Center Department of Neurological Sciences
state: Illinois
city: Overland Park
country: United States
facility: Kansas City Bone & Joint Clinic, PA Overland Park
state: Kansas
city: Lexington
country: United States
facility: Baptist Neurology Center - Lexington
state: Kentucky
city: Baton Rouge
country: United States
facility: The Neuro Medical Center
state: Louisiana
city: Southfield
country: United States
facility: The Parkinson's and Movement Disorders Center
state: Michigan
city: Eagan
country: United States
facility: Rehabilitation Consultants, PA
state: Minnesota
city: Jackson
country: United States
facility: Methodist Rehabilitation Center
state: Mississippi
city: Reno
country: United States
facility: University of Nevada School of Medicine
state: Nevada
city: Latham
country: United States
facility: Empire Neurology PC, the MS Center of Northeastern New York
state: New York
city: Raleigh
country: United States
facility: Raleigh Neurology Associates
state: North Carolina
city: Cincinnati
country: United States
facility: Riverhills Neuroscience
state: Ohio
city: Cincinnati
country: United States
facility: University Neurology, Inc.
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Center for Neurological Restoration
state: Ohio
city: Gahanna
country: United States
facility: Capital Neurology Services & MS Institute
state: Ohio
city: Tulsa
country: United States
facility: Neurological Associates of Tulsa
state: Oklahoma
city: Hood River
country: United States
facility: Columbia Pain Management, PC
state: Oregon
city: Pittsburgh
country: United States
facility: Allegheny General Hospital_Department of Neurology
state: Pennsylvania
city: Port Royal
country: United States
facility: Coastal Neurology, PA
state: South Carolina
city: San Antonio
country: United States
facility: Victorium Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Neurology Center of San Antonio
state: Texas
city: Virginia Beach
country: United States
facility: Gershon Pain Specialists
state: Virginia
city: Kirkland
country: United States
facility: Evergreen Hospital Medical Center/Booth Gardner Parkinson's Care Center
state: Washington
city: Tacoma
country: United States
facility: South Puget Sound Neurology
state: Washington
city: La Crosse
country: United States
facility: Gundersen Clinic, Ltd.
state: Wisconsin
Study officials:
affiliation: Ipsen
name: Ipsen Study Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.