A Study to Evaluate the Safety and Effectiveness of Fremanezumab in Adult Migraine Patients

Overview

About this study

The purpose of this study is to to assess the effectiveness of fremanezumab on decreasing migraine-related disability as measured by the MIDAS 12 and headache intensity by the HIT-6.44.

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:

  • Age 18 to 70 years old.
  • English speaking.
  • Diagnosis of CADASIL confirmed by presence of a pathogenic NOTCH3 gene mutation.
  • Diagnosis of migraine for at least 12 months and diagnosis of chronic migraine for at least 28 days according to the International Classification of Headache Disorders.
  • MIDAS score of >10 points.
  • Ability to provide written informed consent.

Exclusion Criteria:

  • History of ischemic stroke within 4 weeks of screening assessment.
  • Screening blood pressure >150 mm Hg.
  • Use of onabotulinum toxin A 4 months prior to trial or other injectable/stimulatory/magnetic method of headache control.
  • Use of opiates or barbiturates 4 days prior to trial.
  • Patients with competing intracerebral pathology (e.g. history of intracerebral hemorrhage, multiple sclerosis).

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 Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

James Meschia, M.D.

Open for enrollment

Contact information:

Vickie Melton

Melton.Vickie@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20461638

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