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Phase 3 Study of ABP-450 (Prabotulinumtoxin A) for the preventive treatment of Episodic and chronic migraine

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Trial Profile

Phase 3 Study of ABP-450 (Prabotulinumtoxin A) for the preventive treatment of Episodic and chronic migraine

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 14 May 2024

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At a glance

  • Drugs Botulinum-Toxin-A (Primary)
  • Indications Migraine
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors AEON Biopharma

Most Recent Events

  • 09 May 2024 Results published in the Media Release.
  • 29 Mar 2024 According to an AEON Biopharma media release, the company announced end-of-Phase 2 (EOP2) meeting resulted in a preliminary alignment on the design and endpoints for the proposed pivotal Phase 3 trials for the preventive treatment of both episodic and chronic migraine.
  • 19 Mar 2024 According to an AEON Biopharma media release, the company announced the end of Phase 2 (EOP2) meeting, the FDA confirmed the primary endpoint to evaluate the change in mean monthly migraine days (MMD) across the entire second injection cycle (weeks 13-24) relative to the 4-week baseline period, as compared to placebo. The EOP2 meeting also confirmed the use of this same primary endpoint for the final analysis of the Phase 2 chronic migraine cohort, as well as for the planned Phase 3 study.

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