Treatment of Meniere's Disease With Nortriptyline-Topiramate Stepwise Regimen: A Randomized Double-Blinded Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Subjective improvement of Meniere's Disease
研究概览
简要总结
Meniere's disease (MD) is a chronic disease with a variety of fluctuating signs and symptoms, which include vertigo, hearing loss, tinnitus (ringing noise in the ear), aural pressure (feeling of ear fullness), and disequilibrium (lack of stability). Vertigo represents one of the most common and distressing problems in MD patients, and it causes various somatic and psychological disorders that interfere with the patient's quality of life. Despite the large economic and emotional impact of symptoms in MD patients, there is no FDA-approved medication to treat this debilitating condition. As such, our objective in this study is to evaluate the therapeutic potential of novel medications in treating MD that have previously shown astonishing promise in our clinical practice.
详细描述
This study is 8 weeks in duration. There are two arms in the experiment: the first is nortriptyline (7.5 mg) plus topiramate (10 mg), the second is hydrochlorothiazide (25 mg) plus triamterene (37.5 mg) with placebo being added in case of a dosage increase. This is a double-blinded trial. Participants will be randomized to one arm for the duration of the trial using simple randomization with a computer-generated number. Both groups may receive dosage increases weekly if symptoms do not improve. Symptomatic survey scores from each arm will be obtained before and after treatment and weekly. An unblinded clinical researcher will also become involved with patients' treatments as they start to report changes in symptoms in order to monitor their safety and provide advice on change in dosage if patients have questions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
No masking: care provider
入排标准
- 年龄范围
- 25 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with active or frequent Meniere's Disease.
- •Male or female between the ages of 25 to 85 years.
- •Subject must be compliant with the medication and attend study visits.
- •Must be able to read and write in the English language to provide consenting.
排除标准
- •Pregnancy will result in automatic exclusion from the study. A urine pregnancy test to rule out pregnancy for all women who are of childbearing potential.
- •Subjects with history of surgery for Meniere's Disease.
- •Subject with history of an adverse reaction to medication being prescribed.
- •Subject suffers from a medical condition or has history that may be concerning to the investigator's clinical opinion.
- •Subjects with psychosis.
- •Subjects with neurological neoplasm.
- •All contraindications for the medications which prevent subjects from randomization will be considered as exclusion criteria.
研究组 & 干预措施
nortriptyline + topiramate
Nortriptyline (starting dose 7.5 mg) plus Topiramate (starting dose 10 mg) with appropriate dosage increase as necessary
干预措施: nortriptyline + topiramate (Drug)
hydrochlorothiazide + triamterene + placebo
hydrochlorothiazide (starting dose 25 mg) plus triamterene (starting dose 37.5 mg) with placebo being added in case of a dosage increase
干预措施: nortriptyline + topiramate (Drug)
结局指标
主要结局
Subjective improvement of Meniere's Disease
时间窗: 8 weeks
The primary outcome variable is derived from the validated Meniere's Disease Outcome Questionnaire (MDOQ) with 18 multiple-choice questions to compare quality of life before and after treatment. The question multiple choices are rated on a scale from 0 to 4 where the higher score indicates the higher quality of life. For each patient, the sum of his/her answers is divided (and x100) by the maximum possible scores for the pre-treatment questions and the post-treatment questions, separately. The outcome measure is the absolute change from pre- to post-treatment scores. Two-sample t test will be used to compare the outcome variable between the two treatment groups.
次要结局
- Visual analog scale (VAS)(8 weeks)
- Sleep Quality Index (SQI)(8 weeks)
- Perceived Stress Scale (PSS)(8 weeks)
- Tinnitus Functional Index (TFI)(8 weeks)
- Patient Health Questionnaire (PHQ)(8 weeks)
- Meniere's Disease Outcomes Questionnaire (MDOQ)(8 weeks)
- Dizziness handicap index (DHI)(8 weeks)
研究者
Hamid Djalilian
Professor, Neurotology and skull base surgery
University of California, Irvine