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 Versus Placebo for the Preventive Treatment of Chronic 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 Versus Placebo for the Preventive Treatment of Chronic Migraine

Completed
Phase of Trial: Phase III

Latest Information Update: 22 Mar 2018

At a glance

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

    • 02 Feb 2018 According to a Teva Pharmaceutical media release, the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for fremanezumab, an anti-calcitonin gene-related peptide (CGRP) antibody for the prevention of episodic and chronic migraine in adults, based on results from the HALO clinical trial program.
    • 18 Dec 2017 According to a Teva Pharmaceuticals media release, the U.S. FDA has accepted for review the company's Biologics License Application (BLA) for fremanezumab for the preventive treatment of migraine. Teva acquired a priority review voucher to expedite the review of fremanezumab and regulatory action is anticipated by mid-2018.
    • 30 Nov 2017 Results published in the New England Journal of Medicine
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