Cervical Dystonia Clinical Trial
— ANCHOR-CDOfficial title:
DYSPORT™ for Injection AbobotulinumtoxinA Neurotoxin Clinical & Health Economics Outcomes Registry in Cervical Dystonia (ANCHOR-CD)
| NCT number | NCT01314365 |
| Other study ID # | A-TL-52120-156 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 2011 |
| Est. completion date | March 2014 |
| Verified date | November 2020 |
| Source | Ipsen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The purpose of the protocol is to determine typical patient response to Dysport in the treatment of adult cervical dystonia (CD).
| 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 |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Ipsen |
United States,
| 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03617367 -
Long-Term Safety and Efficacy of Repeat Treatments of DaxibotulinumtoxinA for Injection in Adults With Isolated Cervical Dystonia (ASPEN-OLS)
|
Phase 3 | |
| Not yet recruiting |
NCT04057911 -
A Trial of Non-invasive Stimulation in Cervical Dystonia
|
N/A | |
| Withdrawn |
NCT02180139 -
tDCS in Cervical Dystonia
|
N/A | |
| Completed |
NCT00541905 -
Daily Dystonia Practice - A Trial to Investigate NT 201, the Duration of Treatment Effect After One Injection Session and in Long-term Treatment in Cervical Dystonia
|
Phase 4 | |
| Unknown status |
NCT00418925 -
Efficacy of Dronabinol for the Treatment of Cervical Dystonia
|
Phase 2 | |
| Not yet recruiting |
NCT05715138 -
Comparison of Pallidal With Subthalamic Deep Brain Stimulation for Cervical Dystonia
|
N/A | |
| Completed |
NCT02131467 -
Safety and Tolerability of Perampanel in Cervical Dystonia
|
Phase 1/Phase 2 | |
| Completed |
NCT02959645 -
Assessment of Brain Activities in Cervical Dystonia
|
||
| Completed |
NCT03805152 -
Abobotulinum Toxin and Neubotulinum Toxin Injection in Cerivical Dystonia
|
Phase 3 | |
| Completed |
NCT04949594 -
Relief of Pain in Patients With Cervical Dystonia Through the Use of Transcutaneous Electric Nerve Stimulation (TENS)
|
||
| Recruiting |
NCT01664013 -
The Impact of Botulinum Toxin Treatment in Quality of Life of Cervical Dystonia Patients
|
Phase 4 | |
| Completed |
NCT00447772 -
Study to Assess the Efficacy and Safety of Dysport® in Cervical Dystonia
|
Phase 3 | |
| Completed |
NCT00210431 -
Post Marketing Surveillance Study of Dysport
|
||
| Completed |
NCT05157100 -
Clinical Study of Ingrezza (Valbenazine) for the Treatment of Cervical Dystonia
|
Phase 4 | |
| Completed |
NCT00257660 -
Randomized, Placebo-Controlled Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia
|
Phase 3 | |
| Completed |
NCT05103202 -
Efficacy and Safety of 10-Week or Shorter vs 12-Week or Longer Injection Intervals of Botulinum Toxin
|
||
| Terminated |
NCT00760318 -
Keppra for Cervical Dystonia
|
Phase 2 | |
| Completed |
NCT00323765 -
Plasticity in Cervical Dystonia
|
N/A | |
| Completed |
NCT04171258 -
Clinical Trial to Compare the Safety and Efficacy of Botulax® Versus Botox® in Patients With Cervical Dystonia
|
Phase 1 | |
| Completed |
NCT04849988 -
A Phase 2 Study to Evaluate the Safety and Efficacy of ABP-450 in the Treatment of Cervical Dystonia
|
Phase 2 |