Study Title: Repurposed Use of Allergic Rhinitis and Allergic Asthma Drug to Reduce Vertigo and Hearing Loss in Meniere’s disease

This is a double-blind, placebo-controlled randomized study aimed at proof of concept that montelukast, a previously FDA-approved medication that is known to help with allergy symptoms, may have efficacy in alleviating symptoms in patients with Meniere’s Disease.

For the duration of the study, subjects will be instructed to take one pill at night for 90 days. There will be three monthly follow-up visits to clinic to assess any new, worsening, or alleviated symptoms. Each subject will be given a drug diary to record when the drug was taken and any symptoms they may be experiencing, and will bring this diary and any unused pills to their next clinic visit before obtaining the next 30-day drug supply.

Inclusion Criteria
  • Adults 18 years of age or older
  • Must meet all AAO-HNS 2020 criteria for definite Meniere’s Disease
  • Must have a skin test positive for allergy. If subject does not have this previously documented, they will be asked to undergo allergy testing for skin test confirmation to at least one allergen.
  • Is already a candidate for treatment with montelukast for allergic rhinitis/failed first line over-the-counter allergy treatment
Exclusion Criteria
  • Had a previous surgical procedure for treatment of vertigo
  • Currently receiving any allergy immunotherapy or taking montelukast or a beta-blocker
  • Pregnant or recent pregnancy (< 8 weeks postpartum, or lactation)
  • Current hospitalization for any reason
  • Any active, acute, or chronic pulmonary disorder other than asthma
  • History of intubation for asthma

If interested, please contact Mahta Marefat, our Clinical Research Coordinator, at:

clinicaltrials@hifla.org

(213) 770-1808