Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Migraine
Type
Interventional
Phase
Phase 4
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: All consented and qualifying subjects will receive erenumab treatment. Questionnaires, cognitive testing, and brain MRIs will be completed pre- and post-treatment.Masking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

Description

The study will include 50 participants with migraine aged 18-65 years who have 10-25 migraine days per month at baseline. Following a 4-week headache diary run-in phase, participants will receive two treatments with once monthly subcutaneous injections of erenumab 140 mg. Questionnaires, structured ...

The study will include 50 participants with migraine aged 18-65 years who have 10-25 migraine days per month at baseline. Following a 4-week headache diary run-in phase, participants will receive two treatments with once monthly subcutaneous injections of erenumab 140 mg. Questionnaires, structured interviews, cognitive tests, quantitative sensory testing and brain imaging will be performed prior to and following erenumab treatment. These data will be collected at early time points after the first treatment as well as at eight weeks following the first treatment to allow for identification of early and late effects of erenumab on clinical, physiologic, and imaging outcomes and to determine if early physiologic and imaging outcomes predict clinical outcomes at eight weeks. Physiologic and imaging data will be compared to already collected data from healthy controls so as to interpret changes that are seen following treatment with erenumab.

Tracking Information

NCT #
NCT03773562
Collaborators
Not Provided
Investigators
Principal Investigator: Todd J Schwedt Mayo Clinic
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