A Phase II Trial on Rizatriptan for Vestibular Migraine

描述（由申请人提供）：前庭性偏头痛（VM），也称为偏头痛性眩晕和偏头痛相关性眩晕，影响约1%的一般人群和10%的头晕门诊患者，但对其临床过程或治疗方法知之甚少。 造成的功能障碍。没有经过验证的治疗方法。临床上已使用各种药物治疗VM，但没有严格的研究数据支持这些做法。曲坦类药物是一种非常有效的治疗偏头痛的药物。病例报告表明曲坦类药物也可能有效治疗VM患者的眩晕发作。一 尝试了对照研究，并提示了益处，但入组的受试者太少，无法达到统计学显著性。我们提出了一个双中心，随机，安慰剂对照，平行组试验利扎曲普坦，以评估其疗效和耐受性治疗前庭发作的VM患者。我们的主要具体目的是检验以下假设：（1）在降低VM患者前庭发作的严重程度和持续时间方面，（2）在减少VM相关的其他症状方面，（3）在改善VM患者的治疗满意度和健康相关生活质量（HRQOL）方面，（4）VM患者对利扎曲普坦的耐受性良好。我们的第二个具体目标是收集VM的临床过程及其常见的合并症的数据，以计划未来的利扎曲普坦和其他药物治疗VM的III期临床试验。本研究将开始，观察期长达6个月，在此期间将测量前庭发作的严重程度和频率。将评估可能混淆利扎曲普坦治疗的共存疾病并使其稳定。在观察期内有两次中度严重前庭发作的患者将立即被随机分组，以2：1的比例用利扎曲普坦或安慰剂治疗随后的三次发作。每次治疗发作后，将测量药物反应和不良反应。将定期收集其他数据，以评价相关症状的严重程度以及治疗满意度和HRQOL的变化。如果成功，这项研究将为VM的循证治疗提供第一批数据，并为更大的III期试验奠定基础。

DESCRIPTION (provided by applicant): Vestibular migraine (VM), also known as migrainous vertigo and migraine-associated vertigo, affects about 1% of the general population and 10% of patients seen in dizziness clinics, yet relatively little is known about its clinical course or the functional impairment that it causes. There is no proven therapy. Various medications have been used clinically to treat VM, but no rigorous research data support these practices. Triptans are a class of medications that are very effective for aborting migraine headaches. Case reports suggest that triptans might also be effective for treating vertigo attacks in patients with VM. One controlled study was attempted and suggested benefit, but too few subjects were enrolled to reach statistical significance. We propose a two-center, randomized, placebo-controlled, parallel group trial of rizatriptan to assess its efficacy and tolerability for treating vestibular attacks n patients with VM. Our primary Specific Aim is to test the hypotheses that rizatriptan will be superior to placebo (1) for reducing the severity and duration of vestibular attacks in patients with VM, (2) for reducing other symptoms associated with VM, (3) for improving treatment satisfaction and health-related quality of life (HRQOL) in patients with VM, and (4) that rizatriptan will be well tolerated by patients with VM. Our secondary Specific Aim is to collect data on the clinical course of VM and its common comorbid conditions to plan future Phase III trials of rizatriptan and other medications for treating VM. This study will begin with an observation period lasting up to 6 months during which the severity and frequency of vestibular attacks will be measured. Co-existing conditions that might confound rizatriptan therapy will be assessed and stabilized. Patients who have two moderately severe vestibular attacks during the observation period will immediately be randomized to treat three subsequent attacks with either rizatriptan or placebo in a ratio of 2:1. Medication response and adverse effects will be measured after each treated attack. Additional data will be collected at regular intervals to evaluate the severity of associated symptoms and changes in treatment satisfaction and HRQOL. If successful, this study will provide the first data for an evidence-based treatment of VM and set the stage for larger Phase III trials.