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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-05

Study Completion Date

2023-09-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Repurposed Use of Allergic Rhinitis and Allergic Asthma Drug to Reduce Vertigo and Hearing Loss in Meniere's Disease

NCT04815187

Meniere Disease Allergic Rhinitis Vertigo

ACTIVE_NOT_RECRUITING PHASE4

OTO-104 for the Treatment of Meniere's Disease

NCT01412177

Meniere's Disease

COMPLETED PHASE2

Safety of APSLXR in Patients Presenting Vertigo of Vestibular Origin or Meniere's Disease

NCT04674735

Meniere Disease Vertigo Vertigo Vestibular

WITHDRAWN PHASE1

Transcutaneous Auricular Vagus Nerve Stimulation for Meniere Disease

NCT06544590

Meniere Disease

COMPLETED

Open Label Study of OTO-104 in Subjects With Meniere's Disease

NCT02740387

Meniere's Disease

TERMINATED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Meniere Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Venlafaxine Arm

Group Type EXPERIMENTAL

Venlafaxine

Intervention Type DRUG

Daily oral intake 37.5 mg

Placebo

Group Type PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type DRUG

Daily oral intake

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Venlafaxine

Daily oral intake 37.5 mg

Intervention Type DRUG

Placebo oral tablet

Daily oral intake

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No