A Study to Explore the Long-Term Safety of TEV-48125 (Fremanezumab) for the Prevention of Cluster Headache (ENFORCE)

A Study to Explore the Long-Term Safety and Efficacy of Fremanezumab (TEV-48125) for the Prevention of Cluster Headache (ENFORCE)

This is a 68-week study to evaluate the long-term safety of fremanezumab in patients with CH. Patients who complete the pivotal studies and enroll into the current study will visit the investigational center for IMP administration, safety and efficacy assessments, and blood and urine collections for pharmacokinetics, immunogenicity (ADAs), and biomarker analyses. Patients will return to the investigational center for a follow-up visit to evaluate ADAs, fremanezumab concentrations, biomarkers, and safety (adverse events and concomitant medications) approximately 7.5 months after the last dose of IMP.


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 275 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Double-Dummy Study to Explore the Long-Term Safety of TEV-48125 for the Prevention of Cluster Headache
Actual Study Start Date: April 27, 2017
Estimated Primary Completion Date:June 11, 2019
Estimated Study Completion Date:June 11, 2019

Arm:
- Experimental: Fremanezumab - A
- Experimental: Fremanezumab - B
- Experimental: Fremanezumab - C