Facial PainPhase 4NCT04249427
Erenumab for Idiosyncratic Facial Pain
A Phase 4 study testing Erenumab Prefilled Syringe in people with Facial Pain and Rhinosinusitis, run by David Jang, M.D. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Facial Pain, Rhinosinusitis
- What is being tested?
- Erenumab Prefilled Syringe
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2021to 11 Jul 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 29Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center and affiliated practices
Durham, North Carolina, 27710
About this study
Official title: A Randomized, Double-Blinded, Single Site Study to Evaluate the Efficacy of Erenumab for Treatment of Idiosyncratic Facial Pain Mimicking Rhinosinusitis
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.
Read the 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.
- Conditions
- Facial Pain, Rhinosinusitis
- Being tested
- Erenumab Prefilled Syringe, Placebo
- Medical subject headings
- Facial Pain, Rhinosinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erenumab Prefilled SyringeDrug
140mg Erenumab, pre-filled syringe given by subcutaneous injection
PlaceboOther
Placebo, pre-filled syringe given by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Erenumab | Active comparator | 140mg Erenumab administered by subcutaneous injection (in the abdomen, thigh, or upper arm), once monthly for six months. Receives: Drug: Erenumab Prefilled Syringe |
| Placebo | Placebo comparator | Placebo administered by subcutaneous injection (in the abdomen, thigh, or upper arm), once monthly for six months. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1,3, and 6 months
Secondary outcomes (10)
Change in SNOT-22 (Sino-nasal Outcome Test)
The SNOT-22 consists of 22 items, each rated from 0 (no problem at all) to 5 (worst possible symptom). SNOT-22 total scores range from 0 to 110, with higher SNOT-22 total scores indicating worse symptoms. Reported as the change from baseline to six months.
Measured: Baseline, 1, 3 and 6 months
Change in Physical Function as Measured by Migraine Functional Impact Questionnaire (MFIQ)
The MFIQ is a 26-item self-report questionnaire, developed to measure the subjective impact of migraine on physical functioning (everyday activities and physical impairment), as well as social and emotional functioning in the past seven days. The MFIQ Physical Function subscale is scored on a scale of 0-100, with higher scores indicating a greater impact. Reported as the change from baseline to six months.
Measured: Baseline, 1, 3 and 6 months
Change in Usual Activities as Measured by Migraine Functional Impact Questionnaire (MFIQ)
The MFIQ is a 26-item self-report questionnaire, developed to measure the subjective impact of migraine on physical functioning (everyday activities and physical impairment), as well as social and emotional functioning in the past seven days. The MFIQ usual activities subscale is scored on a scale of 0-100, with higher scores indicating a greater impact. Reported as the change from baseline to six months.
Measured: Baseline, 1, 3 and 6 months
Change in Social Function as Measured by Migraine Function Impact Questionnaire (MFIQ)
The MFIQ is a 26-item self-report questionnaire, developed to measure the subjective impact of migraine on physical functioning (everyday activities and physical impairment), as well as social and emotional functioning in the past seven days. The MFIQ Social Function subscale is scored on a scale of 0-100, with higher scores indicating a greater impact. Reported as the change from baseline to six months.
Measured: Baseline, 1, 3 and 6 months
Change in Emotional Function as Measured by Migraine Function Impact Questionnaire (MFIQ)
The MFIQ is a 26-item self-report questionnaire, developed to measure the subjective impact of migraine on physical functioning (everyday activities and physical impairment), as well as social and emotional functioning in the past seven days. The MFIQ Emotional Function subscale is scored on a scale of 0-100, with higher scores indicating a greater impact. Reported as the change from baseline to six months.
Measured: Baseline, 1, 3 and 6 months
Change in Overall Impact (Global) as Measured by Migraine Function Impact Questionnaire (MFIQ)
The MFIQ is a 26-item self-report questionnaire, developed to measure the subjective impact of migraine on physical functioning (everyday activities and physical impairment), as well as social and emotional functioning in the past seven days. The MFIQ Overall Impact is scored on a scale of 0-100, with higher scores indicating a greater impact. Reported as the change from baseline to six months.
Measured: Baseline, 1, 3 and 6 months
Change in Mean Number of Days Per Month With Significant Nasal Congestion
Measured by daily diary completion via mobile app. Reported as the change from baseline to six months.
Measured: Baseline, 1, 3 and 6 months
Change in Mean Number of Days Per Month With Significant Rhinorrhea
Measured by daily diary completion via mobile app. Reported as the change from baseline to six months.
Measured: Baseline, 1, 3 and 6 months
Change in Mean Number of Days of Rescue Medication Used Per Month
Measured by daily diary completion via mobile app. Reported as the change from baseline to six months.
Measured: Baseline, 1, 3 and 6 months
Change From Baseline in Mean Daily Pain Score
Measured by daily diary completion via mobile app on a scale of 1-10, where 1=no pain and 10=intense pain. Reported as the change from baseline to six months.
Measured: Baseline, 1, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start10 Feb 2021
- Primary completion11 Jul 2023
- Study completion11 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Facial PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Jang, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Sponsor-investigator, David Jang, M.D., Duke University
- Investigators
- David Jang, MD, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04249427
- Sponsor's protocol ID
- Pro00104284
- Status last verified
- Aug 2024
- First submitted
- 29 Jan 2020
- Last updated
- 24 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blinded, Single Site Study to Evaluate the Efficacy of Erenumab for Treatment of Idiosyncratic Facial Pain Mimicking Rhinosinusitis
- ClinicalTrials.gov ID
- NCT04249427
- Acronym / sponsor ID
- Pro00104284
- Conditions
- Facial Pain, Rhinosinusitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- David Jang, M.D.University, hospital or other
- Collaborators
- Amgen
- Study start
- 10 Feb 2021 (actual)
- Primary completion
- 11 Jul 2023 (actual)
- Study completion
- 11 Jul 2023 (actual)
- First posted
- 31 Jan 2020 (actual)
- Results
- Posted 24 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erenumab | Active comparator | Drug: Erenumab Prefilled Syringe140mg Erenumab administered by subcutaneous injection (in the abdomen, thigh, or upper arm), once monthly for six months. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo administered by subcutaneous injection (in the abdomen, thigh, or upper arm), once monthly for six months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (29 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erenumab Prefilled Syringe140mg Erenumab, pre-filled syringe given by subcutaneous injection | Drug | Erenumab |
| PlaceboPlacebo, pre-filled syringe given by subcutaneous injection | Other | Placebo |
Primary outcome
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.
10 secondary outcomes
Change in SNOT-22 (Sino-nasal Outcome Test)
Time frame: Baseline, 1, 3 and 6 months
Change in Physical Function as Measured by Migraine Functional Impact Questionnaire (MFIQ)
Time frame: Baseline, 1, 3 and 6 months
Change in Usual Activities as Measured by Migraine Functional Impact Questionnaire (MFIQ)
Time frame: Baseline, 1, 3 and 6 months
Change in Social Function as Measured by Migraine Function Impact Questionnaire (MFIQ)
Time frame: Baseline, 1, 3 and 6 months
Change in Emotional Function as Measured by Migraine Function Impact Questionnaire (MFIQ)
Time frame: Baseline, 1, 3 and 6 months
Change in Overall Impact (Global) as Measured by Migraine Function Impact Questionnaire (MFIQ)
Time frame: Baseline, 1, 3 and 6 months
Change in Mean Number of Days Per Month With Significant Nasal Congestion
Time frame: Baseline, 1, 3 and 6 months
Change in Mean Number of Days Per Month With Significant Rhinorrhea
Time frame: Baseline, 1, 3 and 6 months
Change in Mean Number of Days of Rescue Medication Used Per Month
Time frame: Baseline, 1, 3 and 6 months
Change From Baseline in Mean Daily Pain Score
Time frame: Baseline, 1, 3 and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Facial Pain
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
RecruitingPhase 2
Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study
Cancer Pain, Orofacial Pain
Recruiting
An Innovative Cognitive-Behavioral Treatment For Chronic Orofacial Pain
Chronic Primary Orofacial Pain (CPOP), Persistent Idiopathic Facial Pain (PIFP)
RecruitingPhase 2
Phenotype-based Model for Managing Chronic Post-treatment Pain Among Head and Neck Cancer Survivors: a Pilot Study
Chronic Postsurgical Pain, Chronic Post Cancer Surgery Pain
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Jang, MD principal investigator
Duke Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Erenumab Prefilled Syringe in people with Facial Pain and Rhinosinusitis, run by David Jang, M.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mean Number of Days Per Month With Significant Mid-facial Pain or Pressure (time frame: Baseline, 1,3, and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2024.