Clinical Trial: Phase IV-Cervical Dystonia-INTEREST IN CD2

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: An International Observational Prospective Study On Long-Term Response To Botulinum Toxin Type A (BoNT-A) Injections In Subjects Suffering From Idiopathic Cervical Dystonia

Brief Summary: The purpose of the study is to document long-term response in real-life practice after injection cycles with BoNT-A in subjects suffering from idiopathic cervical dystonia (Long-term clinical and pharmaco-economic data).

Detailed Summary:
Sponsor: Ipsen

Current Primary Outcome: Change in subject's satisfaction using a 5-point Likert scale. [ Time Frame: Baseline and at every 3 to 4 months, up to 3 years. ]

Identification of prognostic factors for subject's satisfaction regarding control of symptoms associated with idiopathic CD.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score and severity sub-scale. [ Time Frame: Baseline and at every 3 to 4 months, up to 3 years. ]
    Assessment of severity of CD.
  • Change in tremor associated with CD using Tsui score [ Time Frame: Baseline and at every 3 to 4 months, up to 3 years. ]
  • Change in pain relief assessed using the TWSTRS pain sub-scale. [ Time Frame: Baseline and at every 3 to 4 months, up to 3 years. ]
  • Change in disability will be measured with the TWSTRS disability sub-scale. [ Time Frame: Baseline and at every 3 to 4 months, up to 3 years. ]
  • Pharmaco-economic endpoints [ Time Frame: Baseline and at every 3 to 4 months, up to 3 years. ]
    • Time intervals between injections
    • Changes in concomitant treatments for CD and associated symptoms.
    • Changes in employment status


Original Secondary Outcome: Same as current

Information By: Ipsen

Dates:
Date Received: December 17, 2012
Date Started: December 2012
Date Completion: July 2017
Last Updated: April 7, 2017
Last Verified: April 2017