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Could a common antidepressant and seizure drug tame Meniere's vertigo?

NCT ID NCT05582837

Symptom relief Sponsor: University of California, Irvine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a combination of two existing drugs, nortriptyline and topiramate, can reduce vertigo and other symptoms in people with Meniere's disease. Forty adults with active Meniere's will take the drugs or a placebo for 8 weeks. The goal is to see if this approach improves quality of life and reduces tinnitus and stress.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nortriptyline and topiramate (drug combination)
What this could lead to
If it works, this could offer a new, non-surgical option to ease vertigo and other symptoms of Meniere's disease, improving quality of life.
What could go wrong
This is a small, early-phase trial with only 40 people. The drugs may not work better than a placebo, and side effects like drowsiness or dizziness are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2022

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

25 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients with active or frequent Meniere's Disease. 2. Male or female between the ages of 25 to 85 years. 3. Subject must be compliant with the medication and attend study visits. 4. Must be able to read and write in the English language to provide consenting. Exclusion Criteria: 1. Pregnancy will result in automatic exclusion from the study. A urine pregnancy test to rule out pregnancy for all women who are of childbearing potential. 2. Subjects with history of surgery for Meniere's Disease. 3. Subject with history of an adverse reaction to medication being prescribed. 4. Subject suffers from a medical condition or has history that may be concerning to the investigator's clinical opinion. 5. Subjects with psychosis. 6. Subjects with neurological neoplasm. 7. All contraindications for the medications which prevent subjects from randomization will be considered as exclusion criteria.

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Conditions

The condition(s) this trial relates to.

Meniere disease migraine disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ménière

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of California, Irvine Medical Center ENT Clinic (Pavilion 2)

    RECRUITING

    Orange, California, 92868, United States

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