Treatment of Meniere's Disease With Migraine Medications

NCT05582837 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 20216445
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Meniere's Disease, medication, randomized, trial, migraine

Outcome Measures

Primary Outcomes (1)

• Subjective improvement of Meniere's Disease

  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.

  8 weeks

Secondary Outcomes (7)

• Visual analog scale (VAS)

  8 weeks

• Perceived Stress Scale (PSS)

  8 weeks

• Sleep Quality Index (SQI)

  8 weeks

• Dizziness handicap index (DHI)

  8 weeks

• Tinnitus Functional Index (TFI)

  8 weeks

Study Arms (2)

nortriptyline + topiramate

EXPERIMENTAL

Nortriptyline (starting dose 7.5 mg) plus Topiramate (starting dose 10 mg) with appropriate dosage increase as necessary

Drug: nortriptyline + topiramate

hydrochlorothiazide + triamterene + placebo

ACTIVE COMPARATOR

hydrochlorothiazide (starting dose 25 mg) plus triamterene (starting dose 37.5 mg) with placebo being added in case of a dosage increase

Drug: nortriptyline + topiramate

Interventions

nortriptyline + topiramate DRUG

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

Also known as: Pamelor, Topamax

hydrochlorothiazide + triamterene + placebo; nortriptyline + topiramate

Eligibility Criteria

• Age: 25 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

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

Orange, California, 92868, United States

RECRUITING

MeSH Terms

Conditions

Meniere Disease; Migraine Disorders

Interventions

Nortriptyline; Topiramate

Condition Hierarchy (Ancestors)

Endolymphatic Hydrops; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Officials

• Hamid Djalilian, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hamid R Djalilian

CONTACT

(800) 263-9547; hdjalili@hs.uci.edu

Mehdi Abouzari

CONTACT

(714) 509-6096; mabouzar@hs.uci.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: No masking: care provider
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Neurotology and skull base surgery

Model Details: Participants will be assigned to a study group by chance (like a coin flip) rather than by a medical decision made by the researchers. There are two arms in the study (treatment group which consists of nortriptyline + topiramate, control group which consist of hydrochlorothiazide plus triamterene with placebo), and participants enrolling in the trial will be randomly assigned in a 1:1 fashion to one of the arms. The participant will remain in the same arm for the duration of the study (8 weeks). There may be multiple participants in each arm who are undergoing the study at the same time (parallel model).

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: October 17, 2022
• Study Start: August 1, 2022
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

US (1)