A Study to Evaluate the Safety of Fremanezumab in Patients with Migraine in Routine Clinical Practice
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 20-013218
About this study
The purpose of this study is to evaluate the long-term safety of Fremanezumab in all patients with migraine through evaluation of incidence of all adverse events.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Patient is 18 years of age or older.
- Patient has a diagnosis of migraine.
- Patient has been newly prescribed fremanezumab, non-fremanezumab CGRP-pathway targeting preventive migraine medications, or non-CGRP-pathway targeting preventive migraine medications.
- Patient has had a blood pressure and heart rate measurement recorded by a healthcare provider within 1 week prior to or on the day of informed consent.
Exclusion Criteria:
- Patient has been previously treated with CGRP-pathway targeting preventive migraine medications.
- Per prior authorization criteria, patients will not receive approval for treatment with CGRP-pathway preventative migraine medications without prior treatment with non-CGRP medications.
Eligibility last updated 12/10/21. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Carrie Robertson, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available