A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy and Safety of 2 Dose Regimens of Subcutaneous Administration of TEV-48125 vs Placebo for the Preventive Treatment of Episodic Migraine

Trial Profile

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy and Safety of 2 Dose Regimens of Subcutaneous Administration of TEV-48125 vs Placebo for the Preventive Treatment of Episodic Migraine

Completed
Phase of Trial: Phase III

Latest Information Update: 14 Jun 2018

At a glance

  • Drugs Fremanezumab (Primary)
  • Indications Migraine
  • Focus Registrational; Therapeutic Use
  • Acronyms HALO-EM
  • Sponsors Teva Branded Pharmaceutical Products R&D
  • Most Recent Events

    • 23 May 2018 According to a Teva Pharmaceutical Industries media release, the U.S. Food and Drug Administration (FDA) has extended the goal date of the Biologics License Application (BLA) for fremanezumab.The Prescription Drug User Fee Act (PDUFA) action date for fremanezumab is set for September 16, 2018.
    • 15 May 2018 Results presented in a Teva Pharmaceutical Industries media release.
    • 15 May 2018 According to a Teva Pharmaceutical Industries media release, data from this study has been published in the Journal of the American Medical Association.
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