NCT04249427已完成4 期
A Randomized, Double-Blinded, Single Site Study to Evaluate the Efficacy of Erenumab for Treatment of Idiosyncratic Facial Pain Mimicking Rhinosinusitis
David Jang, M.D.1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2021年2月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Change in Mean Number of Days Per Month With Significant Mid-facial Pain or Pressure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •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.
研究组 & 干预措施
Erenumab
Active Comparator
140mg Erenumab administered by subcutaneous injection (in the abdomen, thigh, or upper arm), once monthly for six months.
干预措施: Erenumab Prefilled Syringe (Drug)
Placebo
Placebo Comparator
Placebo administered by subcutaneous injection (in the abdomen, thigh, or upper arm), once monthly for six months.
干预措施: Placebo (Other)
结局指标
主要结局
Change in Mean Number of Days Per Month With Significant Mid-facial Pain or Pressure
时间窗: 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.
次要结局
- Change in Mean Number of Days Per Month With Significant Nasal Congestion(Baseline, 1, 3 and 6 months)
- 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)
- Change in Overall Impact (Global) as Measured by Migraine Function Impact Questionnaire (MFIQ)(Baseline, 1, 3 and 6 months)
- Change in Mean Number of Days Per Month With Significant Rhinorrhea(Baseline, 1, 3 and 6 months)
- Change in Mean Number of Days of Rescue Medication Used Per Month(Baseline, 1, 3 and 6 months)
- Change From Baseline in Mean Daily Pain Score(Baseline, 1, 3 and 6 months)
研究者
David Jang, M.D.
Associate Professor of Head and Neck Surgery and Communication Sciences
Duke University
研究点 (1)
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