A Prospective, Open-Label Study Examining the Use of Rimegepant ODT 75 mg or Zavegepant Nasal Spray 10 mg for Acute Treatment of Migraine in the Emergency Department Setting
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Percentage of participants with pain relief at 2 hours without rescue medication
研究概览
简要总结
This study evaluates the effectiveness of rimegepant 75 mg orally disintegrating tablet (ODT) single-dose or zavegepant 10 mg nasal spray single-dose as acute migraine treatments during Emergency Department (ED) encounters. Although these two calcitonin gene-related peptide receptors (CGRP) receptor antagonists are FDA-approved for the indication of acute migraine treatment, past studies have been limited to the outpatient setting. If these medications are effective in the Emergency Department, their delivery methods alone may have advantages over intravenous medications commonly used for acute migraine in EDs, including quicker time to treatment delivery, faster pain relief, and reduced ED length of stay. This investigation is a pilot study to examine rimegepant and zavegepant in an ED, to gain insight on effectiveness in this setting.
This study will administer rimegepant 75 mg ODT single-dose or zavegepant 10 mg nasal spray single-dose as acute migraine treatments to 100 patients in the Emergency Department. It is a single center, open-label, non-controlled 2-group clinical trial (allocated 1:1 to rimegepant or zavegepant via pseudo-random assignment). The study will enroll adults in the ED meeting ICHD-3 criteria for migraine or probable migraine, with or without aura.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •At least 18 years of age
- •Capacity to provide informed consent (without a Legally Authorized Representative)
- •Prior migraine diagnosis (clinical or self-reported)
- •Emergency Department presentation for a headache fulfilling International Classification of Headache Disorders (ICHD-3) criteria for migraine with typical aura or without aura, or criteria for probable migraine with typical aura or without aura. Duration of migraines should be ≥ 1 year. It is acceptable if current headache duration is >72 hours. Must have been headache free for >48 hours prior to current attack.
- •Willingness to participate in post-discharge telephone or electronic follow-up assessments
排除标准
- •Suspected secondary headache due to another cause, or primary headache disorder other than migraine or probable migraine
- •Prior healthcare encounter for headache within 7 days
- •Use of analgesics or abortive headache medications within 2 hours of consent
- •Use of intranasal decongestant within 12 hours of consent
- •Use of the following drug/food categories with potential for drug interactions within 7 days or 5 half-lives, whichever is longer: 1) CYP3A strong or moderate inducers, 2) CYP3A4 strong inhibitors, 3) P-glycoprotein (P-gp) inhibitors, 4) OATP1B3 transporter potent inhibitors/inducers, 5) NTCP transporter potent inhibitors/inducers
- •History of cardiovascular disease, hypertension, or diabetes, recently diagnosed or currently uncontrolled or unstable
- •History of stroke, peripheral vascular disease, or medically-diagnosed Raynaud's Phenomenon
- •History of severe hepatic impairment, as assessed by the investigator or qualified delegate
- •History of kidney disease stage 4 (creatinine clearance <30 mL/min or eGFR <35 mL/min/1.73 m2)
- •History of nasal condition that may affect zavegepant administration, as assessed by the investigator or qualified delegate
- •History of hypersensitivity reaction to rimegepant, zavegepant, or to any included inactive ingredients
- •Lifetime use of CGRP-targeting acute or preventive migraine medications
- •In custody of law enforcement
- •Current pregnancy or lactation
研究组 & 干预措施
Rimegepant
Participants in this arm will receive a single dose of rimegepant 75 mg orally disintegrating tablet (ODT) for acute migraine treatment during an Emergency Department (ED) encounter.
干预措施: Rimegepant (Drug)
Zavegepant
Participants in this arm will receive a single dose of zavegepant 10 mg nasal spray for acute migraine treatment during an Emergency Department (ED) encounter.
干预措施: Zavegepant (Drug)
结局指标
主要结局
Percentage of participants with pain relief at 2 hours without rescue medication
时间窗: 120 minutes (2 hours)
Percentage of participants reporting pain as 'mild' or 'none' at 2 hours post-study drug administration, without rescue medication. Pain is categorized as none, mild, moderate, or severe.
次要结局
- Percentage of participants with pain relief at 2 hours post treatment(120 minutes (2 hours) post treatment)
- Percentage of participants with pain relief at 60 minutes post treatment(60 minutes post treatment)
研究者
Jonathan Schimmel
Associate Professor
Icahn School of Medicine at Mount Sinai