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DYSPORT™ Clinical & Health Economics Outcomes Registry in Cervical Dystonia

Completed
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
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Proportion of treatment responders using the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) severity scale scoreCycle 1 - Baseline and week 4
Patient Global Impression of Change using the 7-point Likert scaleCycle 1 - Baseline and week 4
Secondary Outcome Measures
NameTimeMethod
Clinical Global Impression of Change using the 7-point Likert scaleCycle 1 - Week 4 and early termination visit
Patient Global Impression of Change using the 7-point Likert scaleCycle 1 - Week 4; Cycles 2 to 4 - Baseline, week 4 and termination visits
Time to Waning Effect of Dysport treatment/symptom re-emergenceCycles 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

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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Arizona Dystonia Institute
🇺🇸Scottsdale, Arizona, United States

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