A Randomized, Open-Label, Multi-Center Study of Vestibular Migraine Prevention: Rimegepant Versus Flunarizine Non-inferiority Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- MVSDs
研究概览
简要总结
Vestibular migraine is a common condition that causes repeated episodes of dizziness or vertigo, often with migraine headaches, sensitivity to light and sound, and nausea. It affects 1% to 2.7% of the general population and is one of the most frequent diagnoses in dizziness clinics. Despite its prevalence, there is very little high-quality evidence to guide preventive treatment.
This study compares two preventive treatments for vestibular migraine: rimegepant (a newer medication that blocks a protein called CGRP involved in migraine attacks) and flunarizine (a medication commonly used for vestibular migraine prevention in some countries). The study hypothesis is that rimegepant is not inferior to flunarizine in reducing the number of days with moderate-to-severe vestibular symptoms.
Approximately 400 adults aged 18 to 75 with definite vestibular migraine will be enrolled across multiple countries (China, Italy, Spain, and the United Kingdom). Participants will be randomly assigned in a 1:1 ratio to receive either rimegepant 75 mg once daily or flunarizine 10 mg once nightly for 12 weeks. The total study participation is 20 weeks, including a 4-week observation period, a 12-week treatment period, and a 4-week safety follow-up period. Participants will complete daily electronic diaries to record their symptoms throughout the study.
The primary outcome is the change in the number of moderate-to-severe vestibular symptom days from the observation period to weeks 13-16, comparing the two treatment groups. Secondary outcomes include treatment completion rates, changes in monthly migraine days, adverse events, and patient-reported outcomes including dizziness-related disability, anxiety, depression, and global impression of change.
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 subjects aged 18 to 75 years；
- •Diagnosis of definite vestibular migraine per Bárány society criteria： A. At least 5 episodes with vestibular symptoms of moderate or severe intensity, lasting 5 min to 72 hours； B. Current or previous history of migraine with or without aura according to the International Classification of Headache Disorders (ICHD)；
- •C. One or more migraine features with at least 50% of the vestibular episodes:
- •headache with at least two of the following characteristics:
- •one sided location
- •pulsating quality
- •moderate or severe pain intensity
- •aggravation by routine physical activity
- •photophobia and phonophobia；
- •visual aura; D. Not better accounted for by another vestibular or ICHD diagnosis.
- •Baseline (day 0 to 28) moderate or severe vestibular symptom days ≥ 4;
- •80% adherence or better to electronic diary(eDiary) during observational phase
- •VM-PATHI2(Vestibular Migraine Patient Assessment Tool and Handicap Inventory) score > 25 at screening and baseline visit;
- •Written informed consent must be obtained before patient enrolled;
- •Fluency in local main language;
- •Access to email, and cell phone.
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 use of any prophylactic medication targeting the calcitonin gene-related peptide (CGRP);
- •Prior or current treatment with flunarizine;
- •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;
- •Other conditions judged by the investigator as unsuitable for inclusion.
研究组 & 干预措施
Group A
Rimegepant ODT 75 mg once daily
干预措施: Rimegepant (Drug)
Group B
Flunarizine 10 mg once nightly
干预措施: Flunarizine (Drug)
结局指标
主要结局
MVSDs
时间窗: from baseline to weeks 13-16
Change from the observation phase in moderate-to-severe monthly vestibular symptom days (MVSDs) (as defined by Bárány Society) at weeks 13-16. MVSD = monthly vestibular symptom day, prorated to 28 days. Recommend not to specify that groups A and B are being compared in the description of the endpoint per se. (recommendation agreed)
次要结局
- Percentage of participants(from baseline to weeks 5-16)
- MVSDs 2(from baseline to weeks 5-8 and weeks 9-12)
- TEAEs(from baseline to weeks 5-16)
- MVSDs3(from baseline to weeks 13-16)
- MMDs(from baseline to weeks 5-8, weeks 9-12, and weeks 13-16)
- ≥50% reduction(from baseline to weeks 13-16)
- DHI(from baseline at week 16)
- GAD-7(from baseline at week 16)
- PHQ-9(from baseline at week 16)
- PGIC(from baseline at week 16)