Trial | NCT04218123  Report issue

Official Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    Venlafaxine ...

  • Study Participants

    40
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 Started
Feb 05
2020
Primary Completion
Sep 13
2023
Study Completion
Sep 14
2023
Last Update
Sep 28
2023

Drug Venlafaxine

Daily oral intake 37.5 mg

Drug Placebo oral tablet

Daily oral intake

Venlafaxine Arm Experimental

Placebo Placebo Comparator

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.
No Results Posted