Clinical trial NCT04218123: Assessing the Efficacy of a Serotonin and Norepinephrine Reuptake Inhibitor for Improving Meniere's Disease Outcomes
Official title: Assessing the Efficacy of a Serotonin and Norepinephrine Reuptake Inhibitor for Improving Meniere's Disease Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Meniere Disease
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: American Hearing Research Foundation
name: Cures Within Reach
First posted: 2020-01-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Number of Vertigo Episodes
timeFrame: 6 months
measure: Severity of Vertigo
timeFrame: 6 months
Secondary outcomes:
measure: Change in Score on The Medical Outcomes Study 20-item Short Form Health Survey
timeFrame: Baseline to end of treatment (6 months)
measure: Change in Score on The Meniere's Disease Patient-Oriented Symptom Index (MDPOSI)
timeFrame: Baseline to end of treatment (6 months)
measure: Change in Score on Penn State Worry Questionnaire (PSWQ)
timeFrame: Baseline to end of treatment (6 months)
measure: Change in Score on Patient Health Questionnaire (PHQ9)
timeFrame: Baseline to end of treatment (6 months)
measure: Change in Score on Cognitive Failure Questionnaire (CFQ)
timeFrame: Baseline to end of treatment (6 months)
measure: Change in Score on Neuropsychological Vertigo Inventory (NVI)
timeFrame: Baseline to end of treatment (6 months)
measure: Change in Score on Dizziness Handicap Inventory (DHI)
timeFrame: Baseline to end of treatment (6 months)
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical Univeristy of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Habib Rizk, MD
role: PRINCIPAL_INVESTIGATOR
References: