Erenumab for Idiosyncratic Facial Pain

Study Overview
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Brief Summary
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This is a phase IV randomized, double-blinded, placebo-controlled study to evaluate the efficacy of Erenumab in subjects with midfacial pain or pressure, without clinical or radiographic evidence of sinusitis.

Detailed Description
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Eligible participants are randomized to receive either Erenumab or placebo by subcutaneous injection once monthly for 6 months. Study duration is eight months which includes a 30 day screening/lead-in period and 6 monthly treatment visits followed by a follow-up visit one month following the last dose of study drug administration. Participants will be expected to score on a scale of 1 to 10 their symptoms of facial pain/pressure, nasal congestion, and rhinorrhea as well well as any rescue medicines taken for pain each day via a mobile app.

Official Title
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A Randomized, Double-Blinded, Single Site Study to Evaluate the Efficacy of Erenumab for Treatment of Idiosyncratic Facial Pain Mimicking Rhinosinusitis

Conditions
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Facial Pain, Rhinosinusitis

Intervention / Treatment
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* Drug: Erenumab Prefilled Syringe
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults 18 years of age and older presenting to Duke Head & Neck Surgery and Communications Sciences clinic for evaluation of rhinosinusitis and/or facial pain or pressure. Symptoms are present at least 10 days a month for the last 3 months as reported by subject. Symptoms must include midfacial pain or uncomfortable pressure (may be unilateral or bilateral), which is defined as pain in the regions overlying the maxillary, ethmoid, frontal sinuses either together or individually. Nasal endoscopy in the last three months shows no signs of inflammation (i.e. thick drainage, polyps, watery edema in the middle meatus or spheno-ethmoid recess (mild edema permitted). Sinus CT scan or MRI within 12 months of enrollment during a symptomatic period shows no more than scattered minimal mucosal edema or mucous retention cyst with patent infundibula bilaterally. For subjects with a CT scan more than 12 months old or just an MRI, a CT will be repeated for study purposes. For patients with CT scans less than 12 months old, a CT will be repeated for study purposes if the subject has changes in symptoms suggestive of sinusitis. Ability to read/write English. Has a smart phone, ipod or iPad touch for completion of the EMA on a daily basis. Exclusion Criteria: Hypersensitivity to erenumab or to any of the drug components (acetate, polysorbate, and sucrose). Previous exposure to erenumab or any other CGRP inhibitor in the six months prior to treatment. Allergy to latex. Inability to differentiate facial pain from other headaches. Non-English speaking or unable to provide written informed consent. On a preventative migraine medication (see below) during the 30 day lead-in period: Category 1: Divalproex sodium, sodium valproate Category 2: Topiramate Category 3: Beta blockers (for example: atenolol, bisoprolol, metoprolol, nadolol, ebivolol, pindolol, propranolol, timolol) Category 4: Tricyclic antidepressants (for example: amitriptyline, nortriptyline, protriptyline) Category 5: Serotonin-norepinephrine reuptake inhibitors (for example: venlafaxine, desvenlafaxine, duloxetine, milnacipran) Category 6: Flunarizine, verapamil Category 7: Lisinopril, candesartan Received botulinum toxin (Botox) to the head and neck for migraines in the last four months. More than one major open surgery of the nose or sinuses for sinonasal cancer. History of uncontrolled or unstable blood pressure. History of liver failure. History of metastatic malignancy in the last five years or actively undergoing treatment for cancer. Active seizure disorder or other significant neurological conditions other than migraine. Myocardial infarction (MI), stroke, transient ischemic attack (TIA), unstable angina, or coronary artery bypass surgery or other revascularization procedure within 12 months prior to screening. History or evidence of any other unstable or clinically significant medical condition that in the opinion of the sponsor-investigator/ Principal Investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion. Evidence of drug or alcohol abuse or dependence within 12 months prior to screening, based on medical records or patient self-report. Pregnant or breastfeeding, or expecting to conceive during the study, including through 16 weeks after the last dose of investigational product or placebo Female subject of childbearing potential who is unwilling to use an acceptable method of effective contraception during treatment with investigational product or placebo through 16 weeks after the last dose of investigational product. Female subjects not of childbearing potential are defined as any female who is post-menopausal by history, defined as: Age ≥ 55 years with cessation of menses for 12 or more months, OR Age < 55 years but no spontaneous menses for at least 2 years, OR Underwent bilateral oophorectomy, bilateral salpingectomy, or hysterectomy Unlikely to be able to complete all protocol required study visits or procedures. Currently receiving treatment in another investigational device or drug study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Erenumab<br>140mg Erenumab administered by subcutaneous injection (in the abdomen, thigh, or upper arm), once monthly for six months. | Drug: Erenumab Prefilled Syringe<br>* 140mg Erenumab, pre-filled syringe given by subcutaneous injection<br>|
| Placebo Comparator: Placebo<br>Placebo administered by subcutaneous injection (in the abdomen, thigh, or upper arm), once monthly for six months. | Other: Placebo<br>* Placebo, pre-filled syringe given by subcutaneous injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean number of days per month with significant mid-facial pain or pressure | change in number of days per month with significant mid-facial pain or pressure (defined as greater than 4/10 on scale of 1 - 10) measured by daily dairy completion | Baseline, 1,3, and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in SNOT-22 | Measured by SNOT-22 survey completion | Baseline, 1, 3 and 6 months | 
| Change in Physical Function | Measured by Migraine Function Impact Questionnaire (MFIQ) survey completion | Baseline, 1, 3 and 6 months | 
| Change in Usual Activities | Measured by Migraine Functional Impact Questionnaire (MFIQ) survey completion | Baseline, 1, 3 and 6 months | 
| Change in Social Function | Measured by Migraine Functional Impact Questionnaire (MFIQ) survey completion | Baseline, 1, 3 and 6 months | 
| Change in Emotional Function | Measured by Migraine Functional Impact Questionnaire (MFIQ) survey completion | Baseline, 1, 3 and 6 months | 
| Change in Overall Impact (global) | Measured by Migraine Functional Impact Questionnaire (MFIQ) survey completion | Baseline, 1, 3 and 6 months | 
| Change in average number of days per month with significant nasal congestion | Measured by daily diary completion via mobile app | Baseline, 1, 3 and 6 months | 
| Change in average number of days per month with significant rhinorrhea | Measured by daily diary completion via mobile app | Baseline, 1, 3 and 6 months | 
| Change in doses of rescue pain medications | Measured by daily diary completion via mobile app | Baseline, 1, 3 and 6 months | 
| Change from baseline in mean daily pain score | Measured by daily diary completion via mobile app | Baseline, 1, 3 and 6 months |