Clinical Trial: DYSPORT™ Clinical & Health Economics Outcomes Registry in Cervical Dystonia
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: DYSPORT™ for Injection AbobotulinumtoxinA Neurotoxin Clinical & Health Economics Outcomes Registry in Cervical Dystonia (ANCHOR-CD)
Brief Summary: The purpose of the protocol is to determine typical patient response to Dysport in the treatment of adult cervical dystonia (CD).
Detailed Summary:
Sponsor: Ipsen
Current Primary Outcome:
- Proportion of treatment responders using the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) severity scale score [ Time Frame: Cycle 1 - Baseline and week 4 ]
- Patient Global Impression of Change using the 7-point Likert scale [ Time Frame: Cycle 1 - Baseline and week 4 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Clinical Global Impression of Change using the 7-point Likert scale [ Time Frame: Cycle 1 - Week 4 and early termination visit ]
- Patient Global Impression of Change using the 7-point Likert scale [ Time Frame: Cycle 1 - Week 4; Cycles 2 to 4 - Baseline, week 4 and termination visits ]
- Time to Waning Effect of Dysport treatment/symptom re-emergence [ Time Frame: Cycles 1 to 4 - Week 8 and at study termination visits ]
- Patient-self-administered questionnaire (Cervical Dystonia Impact Profile-58) [ Time Frame: Cycles 1 & 3: Baseline ]
- Patient-reported assessment of pain using the Pain Numeric Rating Scale (NRS) [ Time Frame: Cycles 1 to 4 - Baseline, week 4 and at study termination visits ]
- Treatment Satisfaction Questionnaire for Medication (TSQM) [ Time Frame: Cycle 1 - Week 4; Cycles 2 to 4 - Baseline, week 4 and termination visit ]
Original Secondary Outcome: Same as current
Information By: Ipsen
Dates:
Date Received: March 10, 2011
Date Started: April 2011
Date Completion:
Last Updated: April 29, 2014
Last Verified: April 2014