A Randomized, Double-Blinded, Single Site Study to Evaluate the Efficacy of Erenumab for Treatment of Idiosyncratic Facial Pain Mimicking Rhinosinusitis
Overview
- Phase
- Phase 4
- Intervention
- Erenumab Prefilled Syringe
- Conditions
- Facial Pain
- Sponsor
- David Jang, M.D.
- Enrollment
- 29
- Locations
- 1
- Primary Endpoint
- Change in Mean Number of Days Per Month With Significant Mid-facial Pain or Pressure
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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.
Detailed 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.
Investigators
David Jang, M.D.
Associate Professor of Head and Neck Surgery and Communication Sciences
Duke University
Eligibility Criteria
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)
Arms & Interventions
Erenumab
140mg Erenumab administered by subcutaneous injection (in the abdomen, thigh, or upper arm), once monthly for six months.
Intervention: Erenumab Prefilled Syringe
Placebo
Placebo administered by subcutaneous injection (in the abdomen, thigh, or upper arm), once monthly for six months.
Intervention: Placebo
Outcomes
Primary Outcomes
Change in Mean Number of Days Per Month With Significant Mid-facial Pain or Pressure
Time Frame: Baseline, 1,3, and 6 months
Significant mid-facial pain or pressure defined as greater than 4/10 on scale of 1 to 10, measured by daily diary completion. Reported as the change from baseline to six months.
Secondary Outcomes
- Change in Mean Number of Days Per Month With Significant Nasal Congestion(Baseline, 1, 3 and 6 months)
- Change in SNOT-22 (Sino-nasal Outcome Test)(Baseline, 1, 3 and 6 months)
- Change in Physical Function as Measured by Migraine Functional Impact Questionnaire (MFIQ)(Baseline, 1, 3 and 6 months)
- Change in Usual Activities as Measured by Migraine Functional Impact Questionnaire (MFIQ)(Baseline, 1, 3 and 6 months)
- Change in Social Function as Measured by Migraine Function Impact Questionnaire (MFIQ)(Baseline, 1, 3 and 6 months)
- Change in Emotional Function as Measured by Migraine Function Impact Questionnaire (MFIQ)(Baseline, 1, 3 and 6 months)
- Change in Overall Impact (Global) as Measured by Migraine Function Impact Questionnaire (MFIQ)(Baseline, 1, 3 and 6 months)
- Change in Mean Number of Days Per Month With Significant Rhinorrhea(Baseline, 1, 3 and 6 months)
- Change in Mean Number of Days of Rescue Medication Used Per Month(Baseline, 1, 3 and 6 months)
- Change From Baseline in Mean Daily Pain Score(Baseline, 1, 3 and 6 months)