Treatment of Meniere's Disease With Migraine Medications

Официальное название

Treatment of Meniere's Disease With Nortriptyline-Topiramate Stepwise Regimen: A Randomized Double-Blinded Clinical Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат nortriptyline + topiramate
  nortriptyline (7.5mg) + topiramate (10mg) taken 1x per day and escalate weekly as needed for 8 weeks

Первичные конечные точки

• Subjective improvement of Meniere's Disease [Срок оценки: 8 weeks]

Вторичные конечные точки (7)

• Visual analog scale (VAS) [Срок оценки: 8 weeks]
• Perceived Stress Scale (PSS) [Срок оценки: 8 weeks]
• Sleep Quality Index (SQI) [Срок оценки: 8 weeks]
• Dizziness handicap index (DHI) [Срок оценки: 8 weeks]
• Tinnitus Functional Index (TFI) [Срок оценки: 8 weeks]
• Meniere's Disease Outcomes Questionnaire (MDOQ) [Срок оценки: 8 weeks]
• Patient Health Questionnaire (PHQ) [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of California, Irvine Medical Center ENT Clinic (Pavilion 2) — Orange

Идентификаторы

NCT: NCT05582837 · 20216445

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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