Treatment of Meniere's Disease With Migraine Medications

• ClinicalTrials.gov Identifier: NCT05582837
• Recruitment Status: Recruiting
• First Posted: October 17, 2022
• Last Update Posted: October 17, 2022
• Sponsor: University of California, Irvine
• Information provided by (Responsible Party): Hamid Djalilian, University of California, Irvine

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Ménière	Drug: nortriptyline + topiramate	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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).
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Masking Description: No masking: care provider
• Primary Purpose: Treatment
• Official Title: Treatment of Meniere's Disease With Nortriptyline-Topiramate Stepwise Regimen: A Randomized Double-Blinded Clinical Trial
• Actual Study Start Date: August 1, 2022
• Estimated Primary Completion Date: August 2024
• Estimated Study Completion Date: August 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: nortriptyline + topiramate; Nortriptyline (starting dose 7.5 mg) plus Topiramate (starting dose 10 mg) with appropriate dosage increase as necessary	Drug: nortriptyline + topiramate; nortriptyline (7.5mg) + topiramate (10mg) taken 1x per day and escalate weekly as needed for 8 weeks
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	Drug: nortriptyline + topiramate; nortriptyline (7.5mg) + topiramate (10mg) taken 1x per day and escalate weekly as needed for 8 weeks

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Visual analog scale (VAS) [ Time Frame: 8 weeks ]
   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.
2. Perceived Stress Scale (PSS) [ Time Frame: 8 weeks ]
   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.
3. Sleep Quality Index (SQI) [ Time Frame: 8 weeks ]
   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.
4. Dizziness handicap index (DHI) [ Time Frame: 8 weeks ]
   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.
5. Tinnitus Functional Index (TFI) [ Time Frame: 8 weeks ]
   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.
6. Meniere's Disease Outcomes Questionnaire (MDOQ) [ Time Frame: 8 weeks ]
   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.
7. Patient Health Questionnaire (PHQ) [ Time Frame: 8 weeks ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 25 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Hamid R Djalilian; (800) 263-9547; hdjalili@hs.uci.edu

Contact: Mehdi Abouzari; (714) 509-6096; mabouzar@hs.uci.edu

Locations

United States, California

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

Orange, California, United States, 92868

Contact: Hamid R Djalilian, MD 800-263-9547 hdjalili@hs.uci.edu

Contact: Mehdi Abouzari, MD, PhD 714-509-6096 mabouzar@hs.uci.edu

Principal Investigator: Hamid R Djalilian, MD

Sub-Investigator: Mehdi Abouzari, MD, PhD

Sponsors and Collaborators

University of California, Irvine

More Information

• Responsible Party: Hamid Djalilian, Professor, Neurotology and skull base surgery, University of California, Irvine
• ClinicalTrials.gov Identifier: NCT05582837
• Other Study ID Numbers: 2021-6445
• First Posted: October 17, 2022
• Last Update Posted: October 17, 2022
• Last Verified: October 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Hamid Djalilian, University of California, Irvine:

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

Additional relevant MeSH terms:

Meniere Disease; Endolymphatic Hydrops; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Topiramate; Nortriptyline; Anticonvulsants; Hypoglycemic Agents; Physiological Effects of Drugs; Antidepressive Agents, Tricyclic; Antidepressive Agents; Psychotropic Drugs; Adrenergic Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Adrenergic Agents; Neurotransmitter Agents