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A Phase 3, Open-Label, Multi-Center Trial to Evaluate the Long-Term Safety and Efficacy of Repeat Treatments of DaxibotulinumtoxinA for Injection in Adults With Isolated Cervical Dystonia (ASPEN-OLS)

Trial Profile

A Phase 3, Open-Label, Multi-Center Trial to Evaluate the Long-Term Safety and Efficacy of Repeat Treatments of DaxibotulinumtoxinA for Injection in Adults With Isolated Cervical Dystonia (ASPEN-OLS)

Recruiting
Phase of Trial: Phase III

Latest Information Update: 27 Sep 2018

At a glance

  • Drugs Botulinum-Toxin-A (Primary)
  • Indications Torticollis
  • Focus Adverse reactions; Registrational
  • Acronyms ASPEN-OLS
  • Sponsors Revance Therapeutics
  • Most Recent Events

    • 31 Jul 2018 Planned initiation date changed from 1 Apr 2018 to 30 Jul 2018.
    • 21 Jun 2018 According to a Revance Therapeutics media release, this ASPEN Phase 3 clinical program consist of two studies (Randomized Trial (297124) and Open-Label Trial (290916) ) and expects to enrol 300 patients in this program.
    • 21 Jun 2018 Status changed from planning to recruiting, according to a Revance Therapeutics media release.
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