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Treatment of Meniere's Disease With Migraine Medications

NCT05582837 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-04-13

No results posted yet for this study

Summary

Meniere's disease (MD) is a chronic disease with a variety of fluctuating signs and symptoms, which include vertigo, hearing loss, tinnitus (ringing noise in the ear), aural pressure (feeling of ear fullness), and disequilibrium (lack of stability). Vertigo represents one of the most common and distressing problems in MD patients, and it causes various somatic and psychological disorders that interfere with the patient's quality of life. Despite the large economic and emotional impact of symptoms in MD patients, there is no FDA-approved medication to treat this debilitating condition. As such, our objective in this study is to evaluate the therapeutic potential of novel medications in treating MD that have previously shown astonishing promise in our clinical practice.

Conditions

  • Ménière

Interventions

DRUG

nortriptyline + topiramate

nortriptyline (7.5mg) + topiramate (10mg) taken 1x per day and escalate weekly as needed for 8 weeks

Sponsors & Collaborators

  • University of California, Irvine

    lead OTHER

Principal Investigators

  • Hamid Djalilian, MD · University of California, Irvine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2027-12-30
Completion
2027-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05582837 on ClinicalTrials.gov