Erenumab for Idiosyncratic Facial Pain

NCT04249427 | Completed Phase 4 Results FDA Drug

• 1 other identifier: Pro00104284
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Facial Pain; Rhinosinusitis

Outcome Measures

Primary Outcomes (1)

• Change in Mean Number of Days Per Month With Significant Mid-facial Pain or Pressure

  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.

  Baseline, 1,3, and 6 months

Secondary Outcomes (10)

• 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

Study Arms (2)

Erenumab

ACTIVE COMPARATOR

140mg Erenumab administered by subcutaneous injection (in the abdomen, thigh, or upper arm), once monthly for six months.

Drug: Erenumab Prefilled Syringe

Placebo

PLACEBO COMPARATOR

Placebo administered by subcutaneous injection (in the abdomen, thigh, or upper arm), once monthly for six months.

Other: Placebo

Interventions

Erenumab Prefilled Syringe DRUG

140mg Erenumab, pre-filled syringe given by subcutaneous injection

Erenumab

Placebo OTHER

Placebo, pre-filled syringe given by subcutaneous injection

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• David Jang, M.D.: lead
• Amgen: collaborator

Study Sites (1)

Duke University Medical Center and affiliated practices

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Facial Pain; Rhinosinusitis

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Rhinitis; Respiratory Tract Infections; Infections; Sinusitis; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: David Jang, MD
• Organization: Duke University

david.jang@duke.edu

919-613-6407

Study Officials

• David Jang, MD

  Duke Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Head and Neck Surgery and Communication Sciences

Study Record Dates

• First Submitted: January 29, 2020
• First Posted: January 31, 2020
• Study Start: February 10, 2021
• Primary Completion: July 11, 2023
• Study Completion: July 11, 2023
• Last Updated: September 24, 2024
• Results First Posted: September 24, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)