Assessing the Efficacy of a Serotonin and Norepinephrine Reuptake Inhibitor for Improving Meniere's Disease Outcomes

Medical University of South Carolina40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Meniere Disease

Interventions

VenlafaxineDRUG

Daily oral intake 37.5 mg

Placebo oral tabletDRUG

Daily oral intake

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Study subjects will be prospectively recruited from the population of patients presenting with dizziness to our tertiary, multidisciplinary, vestibular-focused, neurotology clinic. Subjects must meet the following inclusion criteria: * be 18 years of age or older; * have definite MD as defined by the Barany Society 2015 international consensus statement; * have active MD with at least 2 vertigo episodes in the month prior to enrollment; and score at least 36 on the Dizziness Handicap Inventory (DHI), representing at least moderate handicap. Patients with the following will be excluded: * other concurrent vestibular or balance disorder (especially those with vestibular migraine-related vertigo episodes despite not meeting diagnostic criteria for vestibular migraine); * currently taking venlafaxine, SSRIs, or SNRIs; * history of medical (e.g. gentamicin) or surgical (e.g. labyrinthectomy) vestibular ablative treatment; * history of otologic, lateral skull base, or brain surgery; * history of radiation to the head or neck; * known neurologic disorder affecting cognition; * currently taking another serotonin modulating medication; * seizures; * stroke; * myocardial infarction; * hepatic or renal impairment; * hyperlipidemia; * coagulopathy; * psychiatric disorder other than anxiety or depression; * glaucoma; * uncontrolled hypertension; * pregnancy or intention of pregnancy.

Locations (1)

Medical Univeristy of South Carolina

Charleston, South Carolina, United States

Outcomes

Primary Outcomes

Number of Vertigo Episodes

Patients will be keeping a diary throughout the study period and beyond.

Time frame: 6 months

Severity of Vertigo

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)

Time frame: 6 months

Secondary Outcomes

Change in Score on The Medical Outcomes Study 20-item Short Form Health Survey

The Medical Outcomes Study 20-item Short Form Health Survey is a 20-item general health questionnaire to assess quality of life in chronic diseases. It assesses 6 areas of health: physical functioning, role functioning, social functioning, mental health, health perceptions, and pain. Each score ranges between 0 and 100, with 100 indicating best possible function and 0 the worst possible function.

Time frame: Baseline to end of treatment (6 months)

Change in Score on The Meniere's Disease Patient-Oriented Symptom Index (MDPOSI)

The Meniere's Disease Patient-Oriented Symptom Index is a 23-item survey developed as a MD-specific tool to assess the impact of MD symptoms on patients' lives. The score ranges from 0 to 100 with the higher score indicating an active disease with significant impact on function and quality of life.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.