drugset / Trial / NCT04218123

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

NCT04218123 ↗

RandomizedCrossoverQuadruple-blindTreatment

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.

Timeline

Start
2020-02-05
Primary completion
2023-09-13
Completion
2023-09-14

Outcome

Missed primary endpoint

registry analysis (equivalence test); Venlafaxine Arm vs Placebo Arm; p >0.05; ANOVA NCT04218123 ↗

paper This randomized clinical trial failed to identify a difference between venlafaxine and placebo in number of episodes PMID 39235772 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Venlafaxine Small molecule 37.5 mg Oral

Indications