A Study to Explore the Long-Term Safety and Efficacy of Fremanezumab (TEV-48125) for the Prevention of Cluster Headache
Status:
Terminated
Trial end date:
2019-06-11
Target enrollment:
Participant gender:
Summary
This is a 68-week study to evaluate the long-term safety and efficacy of fremanezumab in
participants with cluster headache (CH). Participants who complete the pivotal studies
TV48125-CNS-30056 (NCT02945046) and TV48125-CNS-30057 (NCT02964338) and enroll into the
current study will visit the investigational center for investigational medicinal product
(IMP) administration, safety and efficacy assessments, and blood and urine collections for
pharmacokinetics, immunogenicity (anti-drug antibodies [ADAs]), and biomarker analyses.
Participants 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.
Phase:
Phase 3
Details
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc. Teva Branded Pharmaceutical Products, R&D Inc.