Fremanezumab, Migraine and Sleep

Exclusion Criteria

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• •Currently on a regimen of 1 or more migraine preventative therapy
• •Other significant pain problem (e.g., cancer pain, fibromyalgia, other head or facial pain disorder) that may confound the study assessments
• •Known or suspected severe cardiac disease (e.g., symptomatic coronary artery disease, prior myocardial infarction, congestive heart failure)
• •Known or suspected cerebrovascular disease (e.g., prior stroke or transient ischemic attack, symptomatic carotid artery disease, prior carotid endarterectomy or other vascular neck surgery)
• •Abnormal baseline electrocardiogram (ECG) within the last year (e.g., second or third-degree heart block, prolonged QT interval, atrial fibrillation, atrial flutter, history of ventricular tachycardia or ventricular fibrillation, clinically significant premature ventricular contraction)
• •Uncontrolled high blood pressure (systolic \>160 mm HG, diastolic \>100 mm Hg) after 3 measurements within 24 hours
• •Known history or suspicion of secondary headache
• •Known history or suspicion of substance abuse or addiction (within the last 5 years)
• •Currently using marijuana (including medical marijuana) or has used marijuana (including medical marijuana) or cannabidiol oil within the last 1 year
• •Currently takes simple analgesics or NSAIDs \>15 days per month or triptans, ergots, or combined analgesics \>10 days per month for headaches or other body pain
• •Currently takes prescription opioids for headaches or body pain
• •Undergone nerve block (occipital or other) in the head or neck within the last 3 months
• •Received botulinum toxin or anti-CGRP-mAb injections within the last 6 months
• •Nursing, pregnant or thinking of becoming pregnant during the study period, or of childbearing years and unwilling to use an accepted form of birth control
• •Participating in any other therapeutic clinical investigation or has participated in a clinical trial in the preceding 30 days
• •Belongs to a vulnerable population or has any condition such that his or her ability to provide informed consent, comply with the follow-up requirements, or provide self-assessments is compromised.
• •A relative of or an employee of the Investigator or the clinical study site
• •Psychiatric or cognitive disorder and/or behavioral problems that, in the opinion of the clinician, may interfere with the study
• •History of claustrophobia
• •Diagnosis of obstructive sleep apnea or restless legs syndrome
• •BMI of 30 or greater
• •Daily use of sleep-promoting drugs. These include eszopiclone; zaleplon; zolpidem; benzodiazepines (estazolam, flurazepam, quazepam, temazepam, triazolam); barbiturates (amobarbital, amobarbital-secobarbital, chloral hydrate); doxepin; quetiapine; ramelteon; trazodone; suvorexant; lemborexant; OTC nighttime meds (doxyalamine; diphenydrame); and melatonin.