Treatment of Meniere's Disease With Migraine Medications

Ménière Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05582837
• Other study ID #: 2021-6445
• Status: Recruiting
• Phase: Phase 4
• Start date: August 1, 2022
• Est. completion date: August 2024

Study information

• Verified date: October 2022
• Source: University of California, Irvine
• Contact: Hamid R Djalilian
• Phone: (800) 263-9547
• Email: hdjalili[@]hs.uci.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ménière
• Meniere Disease

Intervention

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

Locations

Country	Name	City	State
United States	University of California, Irvine Medical Center ENT Clinic (Pavilion 2)	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Visual analog scale (VAS)	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.	8 weeks
Secondary	Perceived Stress Scale (PSS)	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.	8 weeks
Secondary	Sleep Quality Index (SQI)	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.	8 weeks
Secondary	Dizziness handicap index (DHI)	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.	8 weeks
Secondary	Tinnitus Functional Index (TFI)	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.	8 weeks
Secondary	Meniere's Disease Outcomes Questionnaire (MDOQ)	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.	8 weeks
Secondary	Patient Health Questionnaire (PHQ)	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.	8 weeks