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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 Epidosic 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 Epidosic Cluster Headache

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 10 Nov 2021

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At a glance

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

    • Most Recent Events

    • 13 Mar 2020 This trial has been completed in Netherland (Global End Date: 23 Apr 2019), according to European Clinical Trials Database record.
    • 23 Apr 2019 According to a Teva Pharmaceutical Industries Media Release, the company is discontinuing the ENFORCE Phase III clinical trial program, which also includes a long-term safety study. As pre-specified futility analysis in episodic cluster headache revealed that the study's primary endpoint of mean change from baseline in the weekly average number of cluster headache attacks during the 4-week treatment period is unlikely to be met.
    • 23 Apr 2019 According to a Teva Pharmaceutical Industries Media Release, Status changed from recruiting to discontinued.

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