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

Condition:   Cluster Headache
Intervention:   Drug: Fremanezumab
Sponsor:   Teva Branded Pharmaceutical Products, R&D Inc.
Enrolling by invitation – verified July 2017
Source: ClinicalTrials.gov Listing of Cluster Headache trials
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.