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NCT Number: NCT05582837

Treatment of Meniere's Disease With Migraine Medications

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.

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Key information

Conditions

Ménière Brain Diseases Central Nervous System Diseases Ear Diseases Endolymphatic Hydrops Headache Disorders Headache Disorders, Primary Labyrinth Diseases Meniere Disease Migraine Disorders Nervous System Diseases Otorhinolaryngologic Diseases

Age range

25 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Orange, California, 92868, United States

Location status: Recruiting

Location contact

Hamid R Djalilian, MD

CONTACT

[email protected]

800-263-9547

Hamid R Djalilian, MD

PRINCIPAL_INVESTIGATOR

Mehdi Abouzari, MD, PhD

CONTACT

[email protected]

714-509-6096

Mehdi Abouzari, MD, PhD

SUB_INVESTIGATOR

About this study

This study is 8 weeks in duration. There are two arms in the experiment: the first is nortriptyline (7.5 mg) plus topiramate (10 mg), the second is hydrochlorothiazide (25 mg) plus triamterene (37.5 mg) with placebo being added in case of a dosage increase. This is a double-blinded trial. Participants will be randomized to one arm for the duration of the trial using simple randomization with a computer-generated number. Both groups may receive dosage increases weekly if symptoms do not improve. Symptomatic survey scores from each arm will be obtained before and after treatment and weekly. An unblinded clinical researcher will also become involved with patients' treatments as they start to report changes in symptoms in order to monitor their safety and provide advice on change in dosage if patients have questions.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with active or frequent Meniere's Disease.
  • Male or female between the ages of 25 to 85 years.
  • Subject must be compliant with the medication and attend study visits.
  • Must be able to read and write in the English language to provide consenting.

Exclusion criteria

  • 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.
  • Subjects with history of surgery for Meniere's Disease.
  • Subject with history of an adverse reaction to medication being prescribed.
  • Subject suffers from a medical condition or has history that may be concerning to the investigator's clinical opinion.
  • Subjects with psychosis.
  • Subjects with neurological neoplasm.
  • All contraindications for the medications which prevent subjects from randomization will be considered as exclusion criteria.

Treatment and study plan

Nortriptyline + Topiramate

Drug

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

Other names: Pamelor, Topamax

Primary outcomes

  1. Subjective improvement of Meniere's Disease

    Time frame: 8 weeks

    The primary outcome variable is derived from the validated Meniere's Disease Outcome Questionnaire (MDOQ) with 18 multiple-choice questions to compare quality of life before and after treatment. The question multiple choices are rated on a scale from 0 to 4 where the higher score indicates the higher quality of life. For each patient, the sum of his/her answers is divided (and x100) by the maximum possible scores for the pre-treatment questions and the post-treatment questions, separately. The outcome measure is the absolute change from pre- to post-treatment scores. Two-sample t test will be used to compare the outcome variable between the two treatment groups.

Secondary outcomes

  1. Visual analog scale (VAS)

    Time frame: 8 weeks

    Subjective improvement in tinnitus loudness severity based on a visual analog scale (VAS). The VAS is scored from 0 to 10, with a higher score representing an increased severity of tinnitus.

  2. Perceived Stress Scale (PSS)

    Time frame: 8 weeks

    Subjective improvement in stress based on perceived stress scale (PSS). The PSS is scored from 0 to 40, with higher scores indicating higher perceived stress.

  3. Sleep Quality Index (SQI)

    Time frame: 8 weeks

    Subjective improvement in sleep quality based on sleep quality index (SQI). The SQI is scored from 0 to 21, with higher scores indicating worse quality of sleep.

  4. Dizziness handicap index (DHI)

    Time frame: 8 weeks

    Subjective improvement in dizziness handicap index (DHI). There is a maximum score of 100 (28 points for physical, 36 points for emotional and 36 points for functional) and a minimum score of 0. The higher the score, the greater the perceived handicap due to dizziness.

  5. Tinnitus Functional Index (TFI)

    Time frame: 8 weeks

    Subjective improvement from baseline in tinnitus symptoms as measured by Tinnitus Functional Index (TFI). The TFI is scored from 0% to 100%, with higher scores indicating a more negative impact of tinnitus.

  6. Meniere's Disease Outcomes Questionnaire (MDOQ)

    Time frame: 8 weeks

    Subjective improvement in Meniere's Disease Outcomes Questionnaire (MDOQ). To measure the quality of life in patients with Ménière's disease and to assess quality-of-life outcomes.

  7. Patient Health Questionnaire (PHQ)

    Time frame: 8 weeks

    Subjective improvement in depression symptoms based on patient health questionnaire (PHQ). The PHQ is scored from 0 to 27, with a higher score indicating increased depression severity.

Study contacts

Contact information is provided by the study sponsor or research team.

Hamid R Djalilian

CONTACT

[email protected]

(800) 263-9547

Mehdi Abouzari

CONTACT

[email protected]

(714) 509-6096

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Official study title

Treatment of Meniere's Disease With Nortriptyline-Topiramate Stepwise Regimen: A Randomized Double-Blinded Clinical Trial

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Oct 17, 2022
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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