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

Medical University of South Carolina (MUSC)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Meniere Disease

Treatments: Drug: Venlafaxine; Drug: Placebo oral tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT04218123

00091200

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Venlafaxine Arm

Experimental group

Treatment:

Drug: Venlafaxine

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo oral tablet