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

• Status: Recruiting
• Trial end date: 2022-03-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of South Carolina
• Collaborators: American Hearing Research Foundation; Cures within Reach Foundation
• Treatments: Norepinephrine; Serotonin; Serotonin and Noradrenaline Reuptake Inhibitors; Venlafaxine Hydrochloride

Criteria

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.