DYSPORT™ Clinical & Health Economics Outcomes Registry in Cervical Dystonia

Completed

Conditions studied: Cervical Dystonia

In brief

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

Key facts

Study ID

NCT01314365

Run by

Ipsen

People needed

350

Starts

2011-04-01

Expected to finish

2014-03-01

Last updated by the study team

2020-11-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Arizona Dystonia Institute — Scottsdale, Arizona, United States
• East Bay Physicians Medical Group — Berkeley, California, 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
• Coastal Neurological Medical Group, Inc. — La Jolla, California, United States
• Valley Parkinson Clinic — Los Gatos, California, United States
• Harvinder S. Birk — Redding, California, United States
• Colorado Springs Neurological Associates — Colorado Springs, Colorado, United States
• University of Colorado Denver — Denver, Colorado, United States
• Georgetown University Hospital — Washington D.C., District of Columbia, 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
• Infinity Clinical Research, LLC — Hollywood, Florida, 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
• Emerald Coast Center for Neurological Disorders — Pensacola, Florida, United States
• Parkinson's Treatment Center of SW Florida — Port Charlotte, Florida, United States
• USF HealthParkinson's Disease and Movement Disorders Center — Tampa, Florida, United States
• Cleveland Clinic Florida — Weston, 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
• Kansas City Bone & Joint Clinic, PA Overland Park — Overland Park, Kansas, United States
• Baptist Neurology Center - Lexington — Lexington, Kentucky, United States
• The Neuro Medical Center — Baton Rouge, Louisiana, United States

Full record on ClinicalTrials.gov

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