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: 28 Jun 2018
At a glance
- Drugs Fremanezumab (Primary)
- Indications Cluster headache
- Focus Adverse reactions; Registrational
- Acronyms ENFORCE
- Sponsors Teva Branded Pharmaceutical Products R&D
- 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 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.
- 02 Nov 2017 Planned number of patients changed from 516 to 600.