Fremanezumab, Migraine and Sleep

• Status: Not yet recruiting
• Trial end date: 2022-12-30
• Target enrollment: 0
• Participant gender: All

Summary

The main goal of this study is to determine whether there is a relationship between fremanezumab's ability to prevent migraine and improved sleep quality in migraine patients (fremanezumab is a FDA-approved humanized CGRP monoclonal antibody for the treatment of migraine).

This is a within-person study design that examines treatment effects (changes) using high-resolution assessments. To complete the study, each participant will be observed using daily assessments of migraine and sleep outcomes before treatment (baseline: 0 to 30 days), and at 1, 2, and 3 months after treatment (injection 1: days 31-60, injection 2: days 61-90, injection 3: days 91-120). In essence, this creates an interrupted time-series design where repeated interventions are introduced at fixed intervals.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beth Israel Deaconess Medical Center
• Collaborator: Teva Pharmaceuticals USA

Criteria

Inclusion Criteria:

• Between the ages of 18 and 65 years

• Been previously diagnosed with migraine (with or without aura), in accordance with the ICHD-3 criteria

• Experiences between 10 to 25 headaches days per month (during the last 3 months), with at least 8 of them being migraine days during which the migraines lasted more than 4 hours if untreated

• Onset of migraine at age 50 years or younger

• Agrees to refrain from initiating or changing the type, dosage, or frequency of any prophylactic medications for indications other than migraine that may interfere with the study objectives (e.g., antidepressants, anticonvulsants, beta-adrenergic blockers, etc.)

• Able to provide written informed consent

• Scoring 10 or higher on the Insomnia Severity Index (8-14 = subthreshold insomnia, 15-21 = clinical insomnia of moderate severity, 22-28 = clinical insomnia of severe severity)

Exclusion Criteria:

• -

• 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.