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