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A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy and Safety of 2 Dose Regimens (Intravenous/Subcutaneous and Subcutaneous) of TEV-48125 Versus Placebo for the Prevention of Chronic Cluster Headache

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Trial Profile

A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy and Safety of 2 Dose Regimens (Intravenous/Subcutaneous and Subcutaneous) of TEV-48125 Versus Placebo for the Prevention of Chronic Cluster Headache

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 10 Mar 2022

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At a glance

  • Drugs Fremanezumab (Primary) ; Fremanezumab (Primary)
  • Indications Cluster headache
  • Focus Therapeutic Use
  • Acronyms ENFORCE
  • Sponsors Teva Branded Pharmaceutical Products R&D

    • Most Recent Events

    • 15 Jun 2018 Status changed from recruiting to discontinued, as reported in the Teva Pharmaceuticals media release.
    • 15 Jun 2018 According to a Teva Pharmaceuticals media release, the company announced that a pre-specified futility analysis 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. As a result, the company will discontinue the trial, along with the long term extension study following this trial.
    • 02 Nov 2017 Planned End Date changed from 30 Oct 2018 to 6 Nov 2018.

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