DYSPORT™ Clinical & Health Economics Outcomes Registry in Cervical Dystonia
- Conditions
- Cervical Dystonia
- Registration Number
- NCT01314365
- Lead Sponsor
- Ipsen
- Brief Summary
The purpose of the protocol is to determine typical patient response to Dysport in the treatment of adult cervical dystonia (CD).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 350
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of treatment responders using the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) severity scale score Cycle 1 - Baseline and week 4 Patient Global Impression of Change using the 7-point Likert scale Cycle 1 - Baseline and week 4
- Secondary Outcome Measures
Name Time Method Clinical Global Impression of Change using the 7-point Likert scale Cycle 1 - Week 4 and early termination visit 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 Time to Waning Effect of Dysport treatment/symptom re-emergence Cycles 1 to 4 - Week 8 and at study termination visits Patient-self-administered questionnaire (Cervical Dystonia Impact Profile-58) Cycles 1 & 3: Baseline Patient-reported assessment of pain using the Pain Numeric Rating Scale (NRS) Cycles 1 to 4 - Baseline, week 4 and at study termination visits Treatment Satisfaction Questionnaire for Medication (TSQM) Cycle 1 - Week 4; Cycles 2 to 4 - Baseline, week 4 and termination visit
Related Research Topics
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Trial Locations
- Locations (45)
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
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