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Erenumab for Idiosyncratic Facial Pain

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ClinicalTrials.gov Identifier: NCT04249427
Recruitment Status : Recruiting
First Posted : January 31, 2020
Last Update Posted : July 7, 2021
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
David Jang, M.D., Duke University

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.

Condition or disease Intervention/treatment Phase
Facial Pain Rhinosinusitis Drug: Erenumab Prefilled Syringe Other: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blinded, Single Site Study to Evaluate the Efficacy of Erenumab for Treatment of Idiosyncratic Facial Pain Mimicking Rhinosinusitis
Actual Study Start Date : February 10, 2021
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : February 2023

Arm Intervention/treatment
Active Comparator: Erenumab
140mg Erenumab administered by subcutaneous injection (in the abdomen, thigh, or upper arm), once monthly for six months.
Drug: Erenumab Prefilled Syringe
140mg Erenumab, pre-filled syringe given by subcutaneous injection

Placebo Comparator: Placebo
Placebo administered by subcutaneous injection (in the abdomen, thigh, or upper arm), once monthly for six months.
Other: Placebo
Placebo, pre-filled syringe given by subcutaneous injection




Primary Outcome Measures :
  1. Change in mean number of days per month with significant mid-facial pain or pressure [ Time Frame: Baseline, 1,3, and 6 months ]
    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


Secondary Outcome Measures :
  1. Change in SNOT-22 [ Time Frame: Baseline, 1, 3 and 6 months ]
    Measured by SNOT-22 survey completion

  2. Change in Physical Function [ Time Frame: Baseline, 1, 3 and 6 months ]
    Measured by Migraine Function Impact Questionnaire (MFIQ) survey completion

  3. Change in Usual Activities [ Time Frame: Baseline, 1, 3 and 6 months ]
    Measured by Migraine Functional Impact Questionnaire (MFIQ) survey completion

  4. Change in Social Function [ Time Frame: Baseline, 1, 3 and 6 months ]
    Measured by Migraine Functional Impact Questionnaire (MFIQ) survey completion

  5. Change in Emotional Function [ Time Frame: Baseline, 1, 3 and 6 months ]
    Measured by Migraine Functional Impact Questionnaire (MFIQ) survey completion

  6. Change in Overall Impact (global) [ Time Frame: Baseline, 1, 3 and 6 months ]
    Measured by Migraine Functional Impact Questionnaire (MFIQ) survey completion

  7. Change in average number of days per month with significant nasal congestion [ Time Frame: Baseline, 1, 3 and 6 months ]
    Measured by daily diary completion via mobile app

  8. Change in average number of days per month with significant rhinorrhea [ Time Frame: Baseline, 1, 3 and 6 months ]
    Measured by daily diary completion via mobile app

  9. Change in doses of rescue pain medications [ Time Frame: Baseline, 1, 3 and 6 months ]
    Measured by daily diary completion via mobile app

  10. Change from baseline in mean daily pain score [ Time Frame: Baseline, 1, 3 and 6 months ]
    Measured by daily diary completion via mobile app



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Symptoms are present at least 10 days a month for the last 3 months as reported by subject.
  3. 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.
  4. 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).
  5. 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.
  6. Ability to read/write English.
  7. Has a smart phone, ipod or iPad touch for completion of the EMA on a daily basis.

Exclusion Criteria:

  1. Hypersensitivity to erenumab or to any of the drug components (acetate, polysorbate, and sucrose).
  2. Previous exposure to erenumab or any other CGRP inhibitor in the six months prior to treatment.
  3. Allergy to latex.
  4. Inability to differentiate facial pain from other headaches.
  5. Non-English speaking or unable to provide written informed consent.
  6. 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
  7. Received botulinum toxin (Botox) to the head and neck for migraines in the last four months.
  8. More than one major surgery of the nose or sinuses. Endoscopic sinus surgery, septoplasty, rhinoplasty, and turbinate surgery are not considered major surgery.
  9. History of uncontrolled or unstable blood pressure.
  10. History of liver failure.
  11. History of malignancy in the last five years except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ.
  12. Active seizure disorder or other significant neurological conditions other than migraine.
  13. 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.
  14. 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.
  15. Evidence of drug or alcohol abuse or dependence within 12 months prior to screening, based on medical records or patient self-report.
  16. Pregnant or breastfeeding, or expecting to conceive during the study, including through 16 weeks after the last dose of investigational product or placebo
  17. 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
  18. Unlikely to be able to complete all protocol required study visits or procedures.
  19. Currently receiving treatment in another investigational device or drug study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04249427


Contacts
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Contact: Victoria Johnson 919-681-4595 vaj5@duke.edu
Contact: Amy Walker 919-684-1732 amy.walker1@duke.edu

Locations
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United States, North Carolina
Duke University Medical Center and affiliated practices Recruiting
Durham, North Carolina, United States, 27710
Contact: David Jang, MD    919-681-7798    david.jang@duke.edu   
Sponsors and Collaborators
David Jang, M.D.
Amgen
Investigators
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Principal Investigator: David Jang, MD Duke Health
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Responsible Party: David Jang, M.D., Associate Professor of Head and Neck Surgery and Communication Sciences, Duke University
ClinicalTrials.gov Identifier: NCT04249427    
Other Study ID Numbers: Pro00104284
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: July 7, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Facies
Facial Pain
Disease Attributes
Pathologic Processes
Pain
Neurologic Manifestations
Erenumab
Calcitonin Gene-Related Peptide Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs