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A Randomized, Multicenter, Dose-Blinded, Phase 2 Extension Study of ABP-450 (prabotulinumtoxinA) Purified Neurotoxin Complex for the Prevention of Migraine Headache

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Trial Profile

A Randomized, Multicenter, Dose-Blinded, Phase 2 Extension Study of ABP-450 (prabotulinumtoxinA) Purified Neurotoxin Complex for the Prevention of Migraine Headache

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 05 Jun 2024

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At a glance

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

    • 29 May 2024 According to AEON Biopharma media release, patients will be monitored for safety purposes through the 12-week period following their last treatment.
    • 12 Dec 2023 According to AEON Biopharma media release, the company is exploring this change in hope that some of the patients who would have otherwise been enrolled in the OLE study will be available to participate in the planned Phase 3 migraine study.
    • 12 Dec 2023 According to AEON Biopharma media release, the company has been in discussions with the FDA regarding adjusting the open label extension (OLE) study period from 48 weeks to 24 weeks to cover 2 treatment cycles instead of the current 4 treatment cycles. To date, there have been 421 patients enrolled in the OLE study across the episodic and chronic migraine Phase 2 cohorts.
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