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A Multicenter, Double-Blind, Double-Dummy Study to Explore the Long-Term Safety and Efficacy of TEV-48125 for the Prevention of Cluster Headache

Trial Profile

A Multicenter, Double-Blind, Double-Dummy Study to Explore the Long-Term Safety and Efficacy of TEV-48125 for the Prevention of Cluster Headache

Recruiting
Phase of Trial: Phase III

Latest Information Update: 16 Jan 2019

At a glance

  • Drugs Fremanezumab (Primary)
  • Indications Cluster headache
  • Focus Adverse reactions; Registrational
  • Acronyms ENFORCE
  • Sponsors Teva Branded Pharmaceutical Products R&D
  • Most Recent Events

    • 07 Jan 2019 Planned End Date changed from 31 Aug 2020 to 9 Oct 2021.
    • 07 Jan 2019 Planned primary completion date changed from 1 Aug 2020 to 9 Oct 2021.
    • 15 Jun 2018 According to a Teva Pharmaceuticals media release, the company will discontinue this extension trial, along with the parent study (700278740). A pre-specified futility analysis of trial 700278740 revealed that the primary endpoint of mean change from baseline in the monthly average number of cluster headache attacks during the 12-week treatment period is unlikely to be met. No safety concerns were observed with fremanezumab treatment in the trial.
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