Erenumab for Idiosyncratic Facial Pain

  • STATUS
    Recruiting
  • End date
    Feb 16, 2023
  • participants needed
    66
  • sponsor
    David Jang, M.D.
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Updated on 16 July 2021
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edema

Summary

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.

Description

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.

Details
Condition Post-Surgical Pain, Oral Facial Pain, faces pain, face pain, Facial Pain, Rhinosinusitis, Pain, Pain (Pediatric)
Treatment Placebo, Erenumab Prefilled Syringe
Clinical Study IdentifierNCT04249427
SponsorDavid Jang, M.D.
Last Modified on16 July 2021

Eligibility

 Yes No Not Sure

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
On a preventative migraine medication (see below) during the 30 day lead-in period
Inability to differentiate facial pain from other headaches
Non-English speaking or unable to provide written informed consent
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)
Received botulinum toxin (Botox) to the head and neck for migraines in the last four months
Category 5: Serotonin-norepinephrine reuptake inhibitors (for example: venlafaxine, desvenlafaxine, duloxetine, milnacipran)
More than one major surgery of the nose or sinuses. Endoscopic sinus surgery, septoplasty, rhinoplasty, and turbinate surgery are not considered major surgery
Category 6: Flunarizine, verapamil
Category 7: Lisinopril, candesartan
Active seizure disorder or other significant neurological conditions other than migraine
History of liver failure
History of malignancy in the last five years except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ
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
History of uncontrolled or unstable blood pressure
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