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A Phase 2, Multicenter, Randomized, Proof-of-Concept, Double-Blind, Placebo-Controlled, Parallel-Group Study, Including an Open-Label Period, Evaluating the Efficacy and Safety of 1 Subcutaneous Dose Regimen of Fremanezumab for the Treatment of Posttraumatic Headache (PTH)

Trial Profile

A Phase 2, Multicenter, Randomized, Proof-of-Concept, Double-Blind, Placebo-Controlled, Parallel-Group Study, Including an Open-Label Period, Evaluating the Efficacy and Safety of 1 Subcutaneous Dose Regimen of Fremanezumab for the Treatment of Posttraumatic Headache (PTH)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 10 Nov 2021

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At a glance

  • Drugs Fremanezumab (Primary)
  • Indications Post-traumatic headache
  • Focus Proof of concept; Therapeutic Use
  • Sponsors Teva Branded Pharmaceutical Products R&D
  • Most Recent Events

    • 06 Jun 2021 Results assessing efficacy and safety of a distinct dose of fremanezumab for the potential treatment of posttraumatic headache, presented at the 63rd Annual Scientific Meeting of the American Headache Society.
    • 06 Jun 2021 Results of HV Study NCT02673567 ( n = 64) and the Phase 2 PTH Study NCT03347188 ( n = 87), assessing evaluation of the correlations between pretreatment plasma CGRP levels, disease characteristics and fremanezumab treatment response in patients with posttraumatic headache, presented at the 63rd Annual Scientific Meeting of the American Headache Society.
    • 22 Apr 2021 Primary endpoint has not been met. (DB Period: Mean Change From Baseline in Monthly Average Number of Headache Days of at Least Moderate Severity During the 12-Week Treatment Period After the First Dose of Fremanezumab), as per Results presented at the 73rd Annual Meeting of the American Academy of Neurology
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