A Placebo Controlled, National, Multi-center, Randomized Clinical Trial of Rimegepant for Vestibular Migraine Evaluation: The REVIVAL Study
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Moderate/Severe vestibular symptom days
研究概览
简要总结
Vestibular migraine (VM) is one of the most common vestibular disorders, affecting 1.0% to 2.7% of the general population1, 7% of patients with definite migranous vertigo in dizziness clinics2, as well as 10.3% of VM patients in headache clinics3; 65% to 85% of VM patients are female1. Despite the relative prevalence of vestibular migraine, evidence-based medicine remains scarce. Two Cochrane reviews published in 2023 found that there is almost no evidence to support the use of medications for the acute treatment or preventive treatment of VM4,5.
Calcitonin gene-related peptide (CGRP) has been established as an excellent target for the treatment of migraine. Animal studies suggest a link between CGRP and vestibular disorders. A prospective observational cohort study found that monoclonal antibodies targeting CGRP receptors and ligands were very effective for vestibular migraine (VM), with 90% of participants experiencing at least a 50% reduction in vertigo attacks6. A small-scale prospective randomized controlled trial showed that a monoclonal antibody targeting a CGRP ligand significantly reduced the number of dizziness days per month in VM patients compared to placebo7. The efficacy of CGRP small molecule antagonists for the preventive and acute treatment of migraines has been widely recognized8,9. Therefore, we speculate that Rimegepant is effective for the preventive and acute treatment of vestibular migraine.
By focusing on a large sample RCT, our study can offer new evidence-based treatment options for patients with vestibular migraine. This is crucial, as many patients with vestibular migraine may not respond well to conventional migraine treatments. Our findings could guide clinicians in choosing more effective therapeutic strategies.
Specifically in acute treatment of vestibular migraine, triptans have failed to show superiority when compared to placebo in treatment vestibular migraine symptoms10. Prochlorperazine, a vestibular sedative, is widely used for acute treatment of vestibular migraine but is known to chronify symptoms11. Should rimegepant demonstrate superiority to placebo in this study, rimegepant could potentially become the first-line treatment for vestibular migraine across the world.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18 to 75 years
- •Documentation of a VM diagnosis according to the Barany Society/ ICHD-31
- •More than 4 definite dizzy days per month in the 3 months prior to screen
- •≥1 prior preventive treatment failure
- •E-diary compliance ≥ 80% during observational phase
排除标准
- •Vestibular hypofunction (unilateral or bilateral)
- •History of ear surgery (other than ear tubes)
- •Other vestibular diagnoses (excluding treated benign paroxysmal positional vertigo (BPPV)), including Meniere's disease, superior semicircular canal dehiscence syndrome, vestibular neuritis, persistent postural-perceptual dizziness, unilateral or bilateral vestibular hypofunction, cerebellar or brainstem disorders, multiple sclerosis, or motion sickness.
- •Prior or current treatment with a CGRP medication
- •Individuals are allergic to rimegepant sulfate oral disintegrating tablets or any excipients of rimegepant sulfate oral disintegrating tablets.
- •Pregnant women, breastfeeding women, or those unwilling to use approved contraceptive methods during the study participation
- •History of serious medical or psychiatric disease, at the discretion of the treating physician (including significant coronary artery disease, peripheral vascular disease, cerebrovascular disease, kidney disease, liver disease, and uncontrolled psychiatric disease or past psychiatric hospitalization)
- •A history of severe medical or psychiatric conditions (including significant coronary artery disease, peripheral vascular disease, cerebrovascular disease, renal disease, liver disease, Raynaud's disease, uncontrolled psychiatric disorders, or previous psychiatric hospitalizations) as determined by the treating physician
- •A history of mania, psychosis, or suicidal ideation
- •A history of drug or alcohol abuse within the 12 months prior to screening, based on the subject's medical records or self-report
- •Individuals who have received head, face, or neck botulinum toxin injections (such as Dysport®, Botox®, Xeomin®, Myobloc®, and JeuveauTM) within 4 months before screening or are scheduled for such injections during the study period
- •Unwilling to use approved form of birth control during the study
- •Ok if on up to 2 migraine prophylactic medications (prescribed for that purpose), dose must be stable for 2 months prior to study start
- •Other conditions judged by the investigator as unsuitable for inclusion
研究组 & 干预措施
Group A1:Rimegepant ODT 75mg, EOD
干预措施: Rimegepant (Drug)
Group A2: Placebo, QD
干预措施: Placebo (Drug)
结局指标
主要结局
Moderate/Severe vestibular symptom days
时间窗: from baseline to weeks 12-16
Change in number of Moderate/Severe vestibular symptom days as defined by Barany Society1 for participants measured daily from the observational phase compared to weeks 12-16.
次要结局
- PHQ-9(from baseline to week 16)
- MMD(every 4 weeks compared to baseline over the 12-week treatment period)
- VADL(from baseline to week 16)
- GAD-7(from baseline to week 16)
- PGIC(from baseline to week 16)
- MSQ(from baseline to week 16)
- Moderate/Severe vestibular symptom days(every 4 weeks during the 12-week treatment period compared to baseline)
- the number of vestibular symptom attacks(every 4 weeks compared to baseline over the 12-week treatment period)
- MIDAS(from baseline to week 16)
- percentage reduction in moderate/severe vestibular symptom days(from baseline to weeks 12-16)
- DHI(from baseline to week 16)