MénièrePhase 4NCT05582837
Treatment of Meniere's Disease With Migraine Medications
A Phase 4 study testing nortriptyline + topiramate in people with Ménière, run by University of California, Irvine at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 25 to 85 years
- Conditions the study is for
- Ménière
- What is being tested?
- nortriptyline + topiramate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 30 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with active or frequent Meniere's Disease.
- Male or female between the ages of 25 to 85 years.
- Subject must be compliant with the medication and attend study visits.
- Must be able to read and write in the English language to provide consenting.
Who cannot join
- 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.
- Subjects with history of surgery for Meniere's Disease.
- Subject with history of an adverse reaction to medication being prescribed.
- Subject suffers from a medical condition or has history that may be concerning to the investigator's clinical opinion.
- Subjects with psychosis.
- Subjects with neurological neoplasm.
- All contraindications for the medications which prevent subjects from randomization will be considered as exclusion criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, Irvine Medical Center ENT Clinic (Pavilion 2)
Orange, California, 92868
Hamid R Djalilian, MD, 800-263-9547, hdjalili@hs.uci.edu
Mehdi Abouzari, MD, PhD, 714-509-6096, mabouzar@hs.uci.edu
About this study
Official title: Treatment of Meniere's Disease With Nortriptyline-Topiramate Stepwise Regimen: A Randomized Double-Blinded Clinical Trial
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.
Read the 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
- Being tested
- nortriptyline + topiramate
- Keywords
- Meniere's Disease, medication, randomized, trial, migraine
- Medical subject headings
- Meniere Disease, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nortriptyline + topiramateDrug
Also called Pamelor, Topamax
nortriptyline (7.5mg) + topiramate (10mg) taken 1x per day and escalate weekly as needed for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| nortriptyline + topiramate | Experimental | Nortriptyline (starting dose 7.5 mg) plus Topiramate (starting dose 10 mg) with appropriate dosage increase as necessary Receives: Drug: nortriptyline + topiramate |
| hydrochlorothiazide + triamterene + placebo | Active comparator | hydrochlorothiazide (starting dose 25 mg) plus triamterene (starting dose 37.5 mg) with placebo being added in case of a dosage increase Receives: Drug: nortriptyline + topiramate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (7)
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start1 Aug 2022
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MénièreStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamid Djalilian, University of California, Irvine
- Investigators
- Hamid Djalilian, MD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05582837
- Sponsor's protocol ID
- 20216445
- Status last verified
- Jun 2026
- First submitted
- 7 Oct 2021
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Meniere's Disease With Nortriptyline-Topiramate Stepwise Regimen: A Randomized Double-Blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT05582837
- Acronym / sponsor ID
- 20216445
- Conditions
- Ménière
- Keywords
- Meniere's Disease, medication, randomized, trial, migraine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 17 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| nortriptyline + topiramate | Experimental | Drug: nortriptyline + topiramateNortriptyline (starting dose 7.5 mg) plus Topiramate (starting dose 10 mg) with appropriate dosage increase as necessary |
| hydrochlorothiazide + triamterene + placebo | Active comparator | Drug: nortriptyline + topiramatehydrochlorothiazide (starting dose 25 mg) plus triamterene (starting dose 37.5 mg) with placebo being added in case of a dosage increase |
Who may qualify
- Ages
- 25 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with active or frequent Meniere's Disease.
- Male or female between the ages of 25 to 85 years.
- Subject must be compliant with the medication and attend study visits.
- Must be able to read and write in the English language to provide consenting.
Key exclusion criteria (7 listed)
- 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.
- Subjects with history of surgery for Meniere's Disease.
- Subject with history of an adverse reaction to medication being prescribed.
- Subject suffers from a medical condition or has history that may be concerning to the investigator's clinical opinion.
- Subjects with psychosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nortriptyline + topiramateAlso: Pamelor, Topamaxnortriptyline (7.5mg) + topiramate (10mg) taken 1x per day and escalate weekly as needed for 8 weeks | Drug | hydrochlorothiazide + triamterene + placebo, nortriptyline + topiramate |
Primary outcome
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.
7 secondary outcomes
Visual analog scale (VAS)
Time frame: 8 weeks
Perceived Stress Scale (PSS)
Time frame: 8 weeks
Sleep Quality Index (SQI)
Time frame: 8 weeks
Dizziness handicap index (DHI)
Time frame: 8 weeks
Tinnitus Functional Index (TFI)
Time frame: 8 weeks
Meniere's Disease Outcomes Questionnaire (MDOQ)
Time frame: 8 weeks
Patient Health Questionnaire (PHQ)
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hamid Djalilian, MD principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing nortriptyline + topiramate in people with Ménière, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hamid R Djalilian ((800) 263-9547, hdjalili@hs.uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective improvement of Meniere's Disease (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.