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| Name | Class |
|---|---|
| Amgen | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erenumab | Active Comparator | 140mg Erenumab administered by subcutaneous injection (in the abdomen, thigh, or upper arm), once monthly for six months. |
|
| Placebo | Placebo Comparator | Placebo administered by subcutaneous injection (in the abdomen, thigh, or upper arm), once monthly for six months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erenumab Prefilled Syringe | Drug | 140mg Erenumab, pre-filled syringe given by subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 1, 3 and 6 months |
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Inclusion Criteria:
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:
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:
Unlikely to be able to complete all protocol required study visits or procedures.
Currently receiving treatment in another investigational device or drug study.
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| Name | Affiliation | Role |
|---|---|---|
| David Jang, MD | Duke Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center and affiliated practices | Durham | North Carolina | 27710 | United States |
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Four participants withdrew prior to administration of injection.
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| ID | Title | Description |
|---|---|---|
| FG000 | Erenumab | 140mg Erenumab administered by subcutaneous injection (in the abdomen, thigh, or upper arm), once monthly for six months. Erenumab Prefilled Syringe: 140mg Erenumab, pre-filled syringe given by subcutaneous injection |
| FG001 | Placebo | Placebo administered by subcutaneous injection (in the abdomen, thigh, or upper arm), once monthly for six months. Placebo: Placebo, pre-filled syringe given by subcutaneous injection |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Erenumab | 140mg Erenumab administered by subcutaneous injection (in the abdomen, thigh, or upper arm), once monthly for six months. Erenumab Prefilled Syringe: 140mg Erenumab, pre-filled syringe given by subcutaneous injection |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | days per month | Baseline, 1,3, and 6 months |
|
6 months
AEs and SAEs were systematically investigated at each study visit and self-reported and recorded using REDCap. Study team was notified via REDCap if subjects self-reported hypertension.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Erenumab | 140mg Erenumab administered by subcutaneous injection (in the abdomen, thigh, or upper arm), once monthly for six months. Erenumab Prefilled Syringe: 140mg Erenumab, pre-filled syringe given by subcutaneous injection |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Jang, MD | Duke University | 919-613-6407 | david.jang@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 14, 2022 | Jun 20, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005157 | Facial Pain |
| D000096825 | Rhinosinusitis |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo | Other | Placebo, pre-filled syringe given by subcutaneous injection |
|
| 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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline, 1, 3 and 6 months |
| Withdrawal by Subject |
|
Placebo administered by subcutaneous injection (in the abdomen, thigh, or upper arm), once monthly for six months. Placebo: Placebo, pre-filled syringe given by subcutaneous injection |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
|
| Secondary | 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. | Participants with data collected at both timepoints. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 1, 3 and 6 months |
|
|
|
|
| Secondary | 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. | Participants with data collected at both timepoints. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 1, 3 and 6 months |
|
|
|
|
| Secondary | 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. | Participants with data collected at both timepoints. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 1, 3 and 6 months |
|
|
|
|
| Secondary | 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. | Participants with data collected at both timepoints. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 1, 3 and 6 months |
|
|
|
|
| Secondary | 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. | Participants with data collected at both timepoints. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 1, 3 and 6 months |
|
|
|
|
| Secondary | 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. | Participants with data collected at both timepoints. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 1, 3 and 6 months |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | days per month | Baseline, 1, 3 and 6 months |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | days per month | Baseline, 1, 3 and 6 months |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | days per month | Baseline, 1, 3 and 6 months |
|
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|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 1, 3 and 6 months |
|
|
|
|
| 0 |
| 13 |
| 2 |
| 13 |
| 7 |
| 13 |
| EG001 | Placebo | Placebo administered by subcutaneous injection (in the abdomen, thigh, or upper arm), once monthly for six months. Placebo: Placebo, pre-filled syringe given by subcutaneous injection | 0 | 12 | 0 | 12 | 6 | 12 |
| Urinary tract infection | Renal and urinary disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Septoplasty | General disorders | Systematic Assessment |
|
| Arm soreness/pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| D012220 | Rhinitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D012852 | Sinusitis |
| D010254 | Paranasal Sinus Diseases |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |