Clinical trial NCT05582837: Treatment of Meniere's Disease With Migraine Medications
Official title: Treatment of Meniere's Disease With Nortriptyline-Topiramate Stepwise Regimen: A Randomized Double-Blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Ménière
Keywords: Meniere's Disease, medication, randomized, trial, migraine
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2022-10-17
Enrollment: 100
Sex: ALL
Minimum age (years): 25
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

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.

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.
7. All contraindications for the medications which prevent subjects from randomization will be considered as exclusion criteria.

Primary outcomes:
measure: Subjective improvement of Meniere's Disease
timeFrame: 8 weeks
Secondary outcomes:
measure: Visual analog scale (VAS)
timeFrame: 8 weeks
measure: Perceived Stress Scale (PSS)
timeFrame: 8 weeks
measure: Sleep Quality Index (SQI)
timeFrame: 8 weeks
measure: Dizziness handicap index (DHI)
timeFrame: 8 weeks
measure: Tinnitus Functional Index (TFI)
timeFrame: 8 weeks
measure: Meniere's Disease Outcomes Questionnaire (MDOQ)
timeFrame: 8 weeks
measure: Patient Health Questionnaire (PHQ)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California, Irvine Medical Center ENT Clinic (Pavilion 2)
state: California
Study officials:
affiliation: University of California, Irvine
name: Hamid Djalilian, MD
role: PRINCIPAL_INVESTIGATOR
References: