Assessing the Efficacy of a Serotonin and Norepinephrine Reuptake Inhibitor for Improving Meniere's Disease Outcomes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of Vertigo Episodes
研究概览
简要总结
As of yet, the cause of Meniere's disease is uncertain and there is no cure. Given the lack of high level evidence for treatments, we seek to perform a randomized, placebo-controlled, double-blind, crossover, pilot trial of venlafaxine for treating Meniere's disease. Venlafaxine is a safe and well-tolerated medication. It has never been trialed in Meniere's disease, but there is evidence that it could be effective in helping with vertigo attacks and other aspects of the disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Venlafaxine Arm
干预措施: Venlafaxine (Drug)
Placebo
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
Number of Vertigo Episodes
时间窗: 6 months
Patients will be keeping a diary throughout the study period and beyond.
Severity of Vertigo
时间窗: 6 months
The study team will use a modified version of vertigo control classification because the treatment phases are 2 months long and the study team will not be able to wait 18-24 months after treatment to assess efficacy per academy guidelines. Previous studies have defined four categories of response to treatment: 1) very good response if more than 75% reduction in vertigo spells frequency and/or intensity, 2) good response if 50-75% reduction, 3) fair response if 25-50% reduction, and 4) poor response if less than 25% reduction. The vertigo classes will be defined as follows; Class A: 0 (complete control of vertigo) Class B: 0-40 or \>60% reduction in mean vertigo episode severity (good control of vertigo) Class C: 41-80 or 20-60% reduction in severity (fair control of vertigo) Class D: 81-120 or -20-20% reduction in severity (no change in vertigo) Class E: \>120 or \>20% worsening in severity (worse vertigo)
次要结局
- Change in Score on The Medical Outcomes Study 20-item Short Form Health Survey(Baseline to end of treatment (6 months))
- Change in Score on Cognitive Failure Questionnaire (CFQ)(Baseline to end of treatment (6 months))
- Change in Score on The Meniere's Disease Patient-Oriented Symptom Index (MDPOSI)(Baseline to end of treatment (6 months))
- Change in Score on Penn State Worry Questionnaire (PSWQ)(Baseline to end of treatment (6 months))
- Change in Score on Patient Health Questionnaire (PHQ9)(Baseline to end of treatment (6 months))
- Change in Score on Dizziness Handicap Inventory (DHI)(Baseline to end of treatment (6 months))
- Change in Score on Neuropsychological Vertigo Inventory (NVI)(Baseline to end of treatment (6 months))
研究者
Habib Rizk,MD
Associate Professor
Medical University of South Carolina