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