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 RU) to placebo, and assessing the short and long term efficacy and safety of Dysport RU following repeated treatments of subjects with cervical dystonia (CD).

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 RU) to placebo, and assessing the short and long term efficacy and safety of Dysport RU following repeated treatments of subjects with cervical dystonia (CD).

Completed
Phase of Trial: Phase III

Latest Information Update: 31 May 2016

At a glance

  • Drugs Botulinum toxin A (Primary)
  • Indications Dystonia; Torticollis
  • Focus Registrational; Therapeutic Use
  • Sponsors Ipsen
  • Most Recent Events

    • 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.
    • 05 Feb 2014 Results published in an Ipsen Media Release.
    • 05 Feb 2014 Primary endpoint 'Toronto-Western-Spasmodic-Torticollis-Rating-Scale' has not been met, according to an Ipsen media release.
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