Imaging the Migraine Brain Pre- and Post-Erenumab
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Erenumab
Intervention description: Erenumab will be used per label instructions.
Intervention MeSH terms: Erenumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Migraine; Magnetic Resonance Imaging; Brain Structure; Brain Function

Summary:

      Researchers are trying to determine if there is a difference between brain images of subjects
      that do respond to treatment with erenumab and subjects who do not respond to treatment with
      erenumab using Magnetic Resonance Imaging (MRI).
    

Eligibility criteria:

        Inclusion Criteria

          -  18-65 years of age

          -  Episodic migraine (with or without aura) or chronic migraine according to the
             diagnostic criteria included within the International Classification of Headache
             Disorders 3 (ICHD-3)

          -  6-25 migraine days per month on average over the 3 months prior to screening,
             confirmed by run-in phase prospective data collection

          -  Duration since migraine onset of at least 12 months prior to screening based on
             medical records and/or patient self-report

        Exclusion Criteria

          -  Older than 50 years of age at migraine onset

          -  History of cluster headache or hemiplegic migraine

          -  Continuous headache pain (i.e. no pain-free periods of any duration during the one
             month before screening)

          -  Opioid- or butalbital-containing analgesics on 6 or more days per month during the 2
             months prior to the start of the baseline phase

          -  History of major psychiatric disorder such as schizophrenia and bipolar disorder

          -  History or evidence of any unstable or clinically significant medical condition, that
             in the opinion of the investigator, would pose a risk to subject safety or interfere
             with the study evaluation, procedures, or completion

          -  No therapeutic response in migraine prevention after an adequate therapeutic trial of
             4 or more of the following medication categories: Category 1- divalproex sodium,
             sodium valproate; Category 2- topiramate; Category 3- beta-blockers; Category 4-
             tricyclic antidepressants; Category 5- venlafaxine or desvenlafaxine, duloxetine or
             milnacipran; Category 6- flunarizine, verapamil; Category 7- lisinopril, candesartan;
             Category 8- botulinum toxin. No therapeutic response is defined as no reduction in
             headache frequency, duration, or severity after administration of the medication for
             at least 6 weeks at the generally accepted therapeutic dose(s) based on the
             investigator's assessment. Lack of sustained response to a medication and failure to
             tolerate a therapeutic dose are not considered to be "no therapeutic response".

          -  Concomitant use of 3 or more of the following medications for migraine prevention
             within 2 months before the start of the baseline phase or throughout the study:
             divalproex sodium, sodium valproate, topiramate, carbamazepine, gabapentin,
             beta-blockers, tricyclic antidepressants, venlafaxine, desvenlafaxine, duloxetine,
             milnacipran, flunarizine, verapamil, lomerizine, lisinopril, candesartan, clonidine,
             guanfacine, cyproheptadine, methysergide, pizotifen, butterbur, feverfew, magnesium
             (at least 600 mg per day), riboflavin (at least 100 mg per day). Use of up to two
             medications is permitted as long as the dose has been stable for at least 2 months
             before the start of the run-in phase and during the study.

          -  Botulinum toxin (in the head and/or neck region) within 4 months before the start of
             the baseline phase and throughout the study

          -  Ergotamine derivatives, steroids, and triptans used for migraine prophylaxis within 2
             months before the start of the baseline phase and throughout the study

          -  Procedures (e.g. nerve blocks) used for migraine prophylaxis within 2 months before
             the start of the baseline phase and throughout the study

          -  History of myocardial infarction, stroke, transient ischemic attack, unstable angina,
             coronary artery bypass surgery, or other revascularization procedures within 12 months
             prior to screening.

          -  Contraindications to MRI including, but not limited to: Metal implants, aneurysm
             clips, severe claustrophobia, implanted electronic devices, insulin or infusion pump,
             cochlear/otologic/ear implant, non-removable prosthesis, implanted shunts/catheters,
             certain intrauterine devices, tattooed makeup, body piercings that cannot be removed,
             metal fragments, wire sutures or metal staples.

          -  Factors that Reduce MR Image Quality and Interpretability: dental braces or other
             non-removable devices (e.g. retainers); prior brain surgery; known brain MRI
             abnormality that in the investigator's opinion will significantly impact MRI data

          -  Sensory disorders that in the investigator's opinion might affect perception of
             cutaneous thermal stimuli (e.g. peripheral neuropathy)

          -  Pregnancy

          -  Lactation

          -  Not willing to use a reliable form of contraception (for women of childbearing
             potential) through 16 weeks after the last dose of erenumab. Acceptable methods of
             birth control include not having intercourse, hormonal birth control methods,
             intrauterine devices, surgical contraceptive methods, or two barrier methods (each
             partner must use a barrier method) with spermicide. A reliable form of contraception
             must be started prior to or at the time of starting the run-in phase. Not being of
             childbearing potential is defined as any woman who: 1) is post-menopausal by history,
             defined as: a) At least 55 years of age with cessation of menses for 12 or more
             months, OR b) Younger than 55 years of age but no spontaneous menses for at least 2
             years, OR c)Younger than 55 years of age and spontaneous menses within the past 1
             year, but currently amenorrheic (e.g. spontaneous or secondary to hysterectomy), AND
             with postmenopausal gonadotropin levels (luteinizing hormone and follicle-stimulating
             hormone levels at least 40 IU/L) or postmenopausal estradiol level (less than 5 ng/dL)
             or according to the definition of "postmenopausal range" for the laboratory involved,
             OR d) Underwent bilateral oophorectomy, OR e) Underwent hysterectomy, OR f) Underwent
             bilateral salpingectomy

          -  Currently receiving treatment in another drug study or an investigational device
             study, or less than 90 days prior to screening since ending treatment on another
             investigational device or drug study(-ies)

          -  Has received calcitonin gene-related peptide (CGRP) monoclonal antibody within 4
             months of the start of the run-in phase

          -  Active chronic pain condition that in the investigator's opinion is unrelated to
             migraine (e.g. chronic pelvic pain)

          -  Acute pain condition that in the investigator's opinion is unrelated to migraine (e.g.
             post-surgical pain)

          -  Unable to provide informed consent

          -  Less than 80% compliance with providing headache diary data during the run-in phase
             (i.e. provides data on less than 80% of days)