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A Phase III, Randomised, Double-blind and Open Label Phase, Active and Placebo Controlled Study Comparing the Short-term Efficacy of Two Formulations of Clostridium Botulinum Type A Toxin (Dysport and Dysport NG) to Placebo, and Assessing the Short and Long Term Efficacy and Safety of Dysport NG Following Repeated Treatments of Subjects With Cervical Dystonia

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Trial Profile

A Phase III, Randomised, Double-blind and Open Label Phase, Active and Placebo Controlled Study Comparing the Short-term Efficacy of Two Formulations of Clostridium Botulinum Type A Toxin (Dysport and Dysport NG) to Placebo, and Assessing the Short and Long Term Efficacy and Safety of Dysport NG Following Repeated Treatments of Subjects With Cervical Dystonia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 29 Oct 2021

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At a glance

  • Drugs Botulinum-Toxin-A (Primary)
  • Indications Torticollis
  • Focus Registrational; Therapeutic Use
  • Sponsors Ipsen

    • Most Recent Events

    • 22 Sep 2021 Results assessing meta-analysis of patient-level data from four randomized, placebo-controlled studies (Truong et al 2005 & 2010, NCT01261611, NCT01753310) of AboBoNT-A 500U and three associated open-label extension studies were presented at the 25th International Congress of Parkinson's Disease and Movement Disorders.
    • 22 Apr 2021 Results of meta analyses of patient level data from four randomized, placebo controlled studies (Truong et al 2005 & 2010, NCT01261611, NCT01753310) of AboBoNT-A 500U and three associated open-label extension studies presented at the 73rd Annual Meeting of the American Academy of Neurology
    • 14 Nov 2014 Results were presented at the Annual Assembly of the Academy of Physical Medicine and Rehabilitation (AAPM&R) according to an Ipsen media release reporting the results.
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