Recruiting

Migraine Medications

Sponsor:

UCLA

Code:

NCT05582837

Conditions

Ménière

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Not accepted

Interventions

nortriptyline + topiramate

Study Details

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

Study ID

NCT05582837

Start date

Aug 1, 2022

Status verified date

Jun, 2026

Completion date

Dec 30, 2027

Anticipated

Primary completion date

Dec 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: nortriptyline + topiramate

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

active comparator: hydrochlorothiazide + triamterene + placebo

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

Interventions

nortriptyline + topiramate

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

Primary outcome measure

  • Subjective improvement of Meniere's Disease [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Hamid R Djalilian

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

Mehdi Abouzari

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

Locations

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

Recruiting

Orange, California, United States, 92868

Contacts

Hamid R Djalilian, MD

800-263-9547hdjalili@hs.uci.edu

Mehdi Abouzari, MD, PhD

714-509-6096mabouzar@hs.uci.edu

Principal Investigator:

Hamid R Djalilian, MD

More Information

Sponsor

University of California, Irvine

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Irvine on 2026-06-22.