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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
29
140mg Erenumab, pre-filled syringe given by subcutaneous injection
Placebo, pre-filled syringe given by subcutaneous injection
Duke University Medical Center and affiliated practices
Durham, North Carolina, United States
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.
Time frame: Baseline, 1,3, and 6 months
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 1, 3 and 6 months
Change in Social Function as Measured by Migraine Function Impact Questionnaire (MFIQ)
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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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 1, 3 and 6 months