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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)

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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)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 16 Apr 2024

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At a glance

  • Drugs Daxibotulinumtoxin A (Primary)
  • Indications Torticollis
  • Focus Adverse reactions; Registrational
  • Acronyms ASPEN-OLS
  • Sponsors Revance Therapeutics

    • Most Recent Events

    • 12 Apr 2024 According to a Revance Therapeutics media release, data assessing patient-desired retreatment intervals and examining the influence of the formulation of DAXXIFY on clinical performance, will be presented at the annual meeting of American Academy of Neurology (AAN), taking place April 13-18, 2024, in Denver, Colorado.
    • 14 Aug 2023 According to a Revance Therapeutics media release, United States (U.S.) Food and Drug Administration (FDA) has approved the first therapeutic indication for DAXXIFY (DaxibotulinumtoxinA-lanm) for injection for the treatment of cervical dystonia in adults.
    • 27 Apr 2023 Results of pooled analysis of two studies (ASPEN-1 & ASPEN-OLS) assessing efficacy, safety, and immunogenicity over multiple treatments of DaxibotulinumtoxinA for Injection in subjects with cervical dystonia, presented at the 75th Annual Meeting of the American Academy of Neurology 2023.
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