Treatment of Meniere's Disease With Migraine Medications

NCT ID: NCT05582837

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2026-12-30

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.

Detailed Description

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.

Conditions

Ménière

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

nortriptyline + topiramate

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

Group Type: EXPERIMENTAL

nortriptyline + topiramate

Intervention Type: DRUG

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

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

Group Type: ACTIVE_COMPARATOR

nortriptyline + topiramate

Intervention Type: DRUG

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

Interventions

nortriptyline + topiramate

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

Intervention Type: DRUG

Other Intervention Names

Pamelor, Topamax

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Hamid Djalilian

Professor, Neurotology and skull base surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hamid Djalilian, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

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

Orange, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Hamid R Djalilian

Role: CONTACT

hdjalili@hs.uci.edu

(800) 263-9547

Mehdi Abouzari

Role: CONTACT

mabouzar@hs.uci.edu

(714) 509-6096

Facility Contacts

Hamid R Djalilian, MD

Role: primary

hdjalili@hs.uci.edu

800-263-9547

Mehdi Abouzari, MD, PhD

Role: backup

mabouzar@hs.uci.edu

714-509-6096

Other Identifiers

20216445

Identifier Type: -

Identifier Source: org_study_id