Meniere DiseasePhase 2/3NCT04218123

Assessing the Efficacy of a Serotonin and Norepinephrine Reuptake Inhibitor for Improving Meniere's Disease Outcomes

A Phase 2/3 study testing Venlafaxine in people with Meniere Disease, run by Medical University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Meniere Disease
What is being tested?: Venlafaxine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteUnited States
Study dates: 5 Feb 2020to 14 Sep 2023
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study subjects will be prospectively recruited from the population of patients presenting with dizziness to our tertiary, multidisciplinary, vestibular-focused, neurotology clinic. Subjects must meet the following inclusion criteria:

be 18 years of age or older;
have definite MD as defined by the Barany Society 2015 international consensus statement;
have active MD with at least 2 vertigo episodes in the month prior to enrollment; and score at least 36 on the Dizziness Handicap Inventory (DHI), representing at least moderate handicap.

Patients with the following will be excluded:

other concurrent vestibular or balance disorder (especially those with vestibular migraine-related vertigo episodes despite not meeting diagnostic criteria for vestibular migraine);
currently taking venlafaxine, SSRIs, or SNRIs;
history of medical (e.g. gentamicin) or surgical (e.g. labyrinthectomy) vestibular ablative treatment;
history of otologic, lateral skull base, or brain surgery;
history of radiation to the head or neck;
known neurologic disorder affecting cognition;
currently taking another serotonin modulating medication;
seizures;
stroke;
myocardial infarction;
hepatic or renal impairment;
hyperlipidemia;
coagulopathy;
psychiatric disorder other than anxiety or depression;
glaucoma;
uncontrolled hypertension;
pregnancy or intention of pregnancy.

Trial locations and contacts

1 site in 1 country.

United States1 site

Medical Univeristy of South Carolina
Charleston, South Carolina, 29425

Other trials in United States

About this study

As of yet, the cause of Meniere's disease is uncertain and there is no cure. Given the lack of high level evidence for treatments, we seek to perform a randomized, placebo-controlled, double-blind, crossover, pilot trial of venlafaxine for treating Meniere's disease. Venlafaxine is a safe and well-tolerated medication. It has never been trialed in Meniere's disease, but there is evidence that it could be effective in helping with vertigo attacks and other aspects of the disorder.

Conditions: Meniere Disease
Being tested: Venlafaxine, Placebo oral tablet
Medical subject headings: Meniere Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VenlafaxineDrug
Daily oral intake 37.5 mg
Placebo oral tabletDrug
Daily oral intake

Study groups in NCT04218123
Study group	Role	What they receive
Venlafaxine Arm	Experimental	Not described Receives: Drug: Venlafaxine
Placebo	Placebo comparator	Not described Receives: Drug: Placebo oral tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Vertigo Episodes
Patients will be keeping a diary throughout the study period and beyond.
Measured: 6 months
Severity of Vertigo
The study team will use a modified version of vertigo control classification because the treatment phases are 2 months long and the study team will not be able to wait 18-24 months after treatment to assess efficacy per academy guidelines. Previous studies have defined four categories of response to treatment: 1) very good response if more than 75% reduction in vertigo spells frequency and/or intensity, 2) good response if 50-75% reduction, 3) fair response if 25-50% reduction, and 4) poor response if less than 25% reduction.
The vertigo classes will be defined as follows; Class A: 0 (complete control of vertigo) Class B: 0-40 or >60% reduction in mean vertigo episode severity (good control of vertigo) Class C: 41-80 or 20-60% reduction in severity (fair control of vertigo) Class D: 81-120 or -20-20% reduction in severity (no change in vertigo) Class E: >120 or >20% worsening in severity (worse vertigo)
Measured: 6 months

Secondary outcomes (7)

Change in Score on The Medical Outcomes Study 20-item Short Form Health Survey
The Medical Outcomes Study 20-item Short Form Health Survey is a 20-item general health questionnaire to assess quality of life in chronic diseases. It assesses 6 areas of health: physical functioning, role functioning, social functioning, mental health, health perceptions, and pain. Each score ranges between 0 and 100, with 100 indicating best possible function and 0 the worst possible function.
Measured: Baseline to end of treatment (6 months)
Change in Score on The Meniere's Disease Patient-Oriented Symptom Index (MDPOSI)
The Meniere's Disease Patient-Oriented Symptom Index is a 23-item survey developed as a MD-specific tool to assess the impact of MD symptoms on patients' lives. The score ranges from 0 to 100 with the higher score indicating an active disease with significant impact on function and quality of life.
Measured: Baseline to end of treatment (6 months)
Change in Score on Penn State Worry Questionnaire (PSWQ)
The PSWQ is a 16-item survey for assessment of anxiety which has been used to identify generalized anxiety disorder. Scores range from 16 (Low worry) to 80 (high worry). A score higher than 60 is indicative of significant anxiety and risk for an anxiety disorder
Measured: Baseline to end of treatment (6 months)
Change in Score on Patient Health Questionnaire (PHQ9)
The Patient Health Questionnaire is a 9-item survey which assesses the severity of depression. A low score is indicative of little to no depressive symptoms, and a high score is indicative of Moderately severe to severe depressive symptoms. Scores range from 0 to 27 with scores higher than 20 indicative of significant risk for depression and scores below 10 indicative at most of a mild depression.
Measured: Baseline to end of treatment (6 months)
Change in Score on Cognitive Failure Questionnaire (CFQ)
The Cognitive Failure Questionnaire is a 25-item survey which assesses cognitive and executive function not tied to any specific disease state. It aims to assess perception, memory, and motor function in everyday tasks.The score ranges from 0 to 100 The higher score on the CFQ, the more frequent the cognitive failures experienced by the subject
Measured: Baseline to end of treatment (6 months)
Change in Score on Neuropsychological Vertigo Inventory (NVI)
The English version of the Neuropsychological Vertigo Inventory consists of 28-items with a 5-point Likert scale for each question. It is a cognitive assessment specific to patients with dizziness. The NVI assesses 7 domains of cognition: space perception, attention, time perception, memory, emotional, visual/ocular and motor. The score ranges from 0 to 140. The higher the score on the NVI the worse the cognitive function of the subject.
Measured: Baseline to end of treatment (6 months)
Change in Score on Dizziness Handicap Inventory (DHI)
The Dizziness Handicap Inventory is a 25-item questionnaire of self-perceived handicap from dizziness.There are 7 questions in the physical domain, 9 in the emotional domain, and 8 in the functional domain. It is scored from 0 (no perceived disability) to 100 (maximum perceived disability).
Measured: Baseline to end of treatment (6 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Feb 202014 Sep 2023

First posted6 Jan 2020
Study start5 Feb 2020
Primary completion13 Sep 2023
Study completion14 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Meniere DiseaseStudies of the same condition, open and under way.
More trials run by Medical University of South CarolinaThe 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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04218123
Sponsor's protocol ID: 00091200
Status last verified: Jun 2024
First submitted: 30 Dec 2019
Last updated: 23 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Rizk H, Monaghan NP, Shah S, Liu Y, Keith BA, Jeong S, Nguyen SA. Efficacy of a Serotonin-Norepinephrine Reuptake Inhibitor as a Treatment for Meniere Disease: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2024 Nov 1;150(11):935-942. doi: 10.1001/jamaoto.2024.2241.
PubMed 39235772

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
CI Following VS Removal or Labyrinthectomy
Vestibular Schwannoma, Meniere Disease
Active, not recruitingPhase 3
SPI-1005 for the Treatment of Meniere's Disease (Open Label)
Meniere's Disease, Ménière's Disease
RecruitingObservational study
Deep Phenotyping of Hearing Instability Disorders: Cohort Establishment, Biomarker Identification, Development of Novel Phenotyping Measures, and Discovery of Therapeutic Targets
Meniere's Disease, Enlarged Vestibular Aqueduct Syndrome
RecruitingPhase 4
Treatment of Meniere's Disease With Migraine Medications
Ménière
RecruitingPhase 2
Effects of Anakinra in Subjects With Corticosteroid-resistant/Intolerant Meniere's Disease and Autoimmune Inner Ear Disease
Autoimmune Inner Ear Disease, Meniere's Disease

All Meniere Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessing the Efficacy of a Serotonin and Norepinephrine Reuptake Inhibitor for Improving Meniere's Disease Outcomes
ClinicalTrials.gov ID: NCT04218123
Acronym / sponsor ID: 00091200
Conditions: Meniere Disease
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Medical University of South CarolinaUniversity, hospital or other
Collaborators: American Hearing Research Foundation, Cures Within Reach
Study start: 5 Feb 2020 (actual)
Primary completion: 13 Sep 2023 (actual)
Study completion: 14 Sep 2023 (actual)
First posted: 6 Jan 2020 (actual)
Results: Posted 24 Jun 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Venlafaxine Arm	Experimental	Drug: Venlafaxine
Placebo	Placebo comparator	Drug: Placebo oral tablet

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

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
VenlafaxineDaily oral intake 37.5 mg	Drug	Venlafaxine Arm
Placebo oral tabletDaily oral intake	Drug	Placebo

Primary outcome

Number of Vertigo Episodes
Time frame: 6 months
Patients will be keeping a diary throughout the study period and beyond.
Severity of Vertigo
Time frame: 6 months
The study team will use a modified version of vertigo control classification because the treatment phases are 2 months long and the study team will not be able to wait 18-24 months after treatment to assess efficacy per academy guidelines. Previous studies have defined four categories of response to treatment: 1) very good response if more than 75% reduction in vertigo spells frequency and/or intensity, 2) good response if 50-75% reduction, 3) fair response if 25-50% reduction, and 4) poor response if less than 25% reduction. The vertigo classes will be defined as follows; Class A: 0 (complete control of vertigo) Class B: 0-40 or >60% reduction in mean vertigo episode severity (good control of vertigo) Class C: 41-80 or 20-60% reduction in severity (fair control of vertigo) Class D: 81-120 or -20-20% reduction in severity (no change in vertigo) Class E: >120 or >20% worsening in severity (worse vertigo)

7 secondary outcomes

Change in Score on The Medical Outcomes Study 20-item Short Form Health Survey
Time frame: Baseline to end of treatment (6 months)
Change in Score on The Meniere's Disease Patient-Oriented Symptom Index (MDPOSI)
Time frame: Baseline to end of treatment (6 months)
Change in Score on Penn State Worry Questionnaire (PSWQ)
Time frame: Baseline to end of treatment (6 months)
Change in Score on Patient Health Questionnaire (PHQ9)
Time frame: Baseline to end of treatment (6 months)
Change in Score on Cognitive Failure Questionnaire (CFQ)
Time frame: Baseline to end of treatment (6 months)
Change in Score on Neuropsychological Vertigo Inventory (NVI)
Time frame: Baseline to end of treatment (6 months)
Change in Score on Dizziness Handicap Inventory (DHI)
Time frame: Baseline to end of treatment (6 months)

Results and safety

Results posted to the registry on 24 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Venlafaxine, Then Placebo	20	18
Placebo, Then Venlafaxine	20	20

Primary outcome: Number of Vertigo Episodes

Time frame: 6 months. Mean (Standard Deviation). Unit: number of episodes

Measure	Venlafaxine Arm n = 40	Placebo Arm n = 40	Baseline Score n = 40
Value	5.41 (4.44)	5.03 (4.57)	13.78 (10.05)

Venlafaxine Arm vs Placebo Arm vs Baseline Score: p <0.001, ANOVA
Venlafaxine Arm vs Baseline Score: p <0.05, ANOVA
Placebo Arm vs Baseline Score: p <0.05, ANOVA

Primary outcome: Severity of Vertigo

Time frame: 6 months. Number. Unit: Percentage of members in arm

Measure	Venlafaxine Arm n = 40	Placebo n = 40
Class A Control	16	24
Class B Control	38	32
Class C Control	30	32
Class D Control	5	3
Class E Control	11	9

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 22 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Venlafaxine Arm	0 of 40 (0%)	6 of 40 (15%)	0 of 40
Placebo	0 of 40 (0%)	3 of 40 (7.5%)	0 of 40

Limitations and caveats (from the sponsor): This study was designed in 2019 with a power analysis that estimated a 20% placebo response in Meniere's Disease. This was a gross underestimation in hindsight. A systematic review with meta-analysis published in 2023 has illustrated that this effect is much stronger, closer to 50% in patients with Meniere's Disease, which may affect the ability to detect symptomatic differences between venlafaxine and placebo treatment periods, respectively.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39235772Rizk H, Monaghan NP, Shah S, Liu Y, Keith BA, Jeong S, Nguyen SA. Efficacy of a Serotonin-Norepinephrine Reuptake Inhibitor as a Treatment for Meniere Disease: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2024 Nov 1;150(11):935-942. doi: 10.1001/jamaoto.2024.2241.
Individual participant dataSharing planned: No

Related trials for Meniere Disease

Active, not recruiting
CI Following VS Removal or Labyrinthectomy
Vestibular Schwannoma, Meniere Disease
Active, not recruitingPhase 3
SPI-1005 for the Treatment of Meniere's Disease (Open Label)
Meniere's Disease, Ménière's Disease
RecruitingObservational study
Deep Phenotyping of Hearing Instability Disorders: Cohort Establishment, Biomarker Identification, Development of Novel Phenotyping Measures, and Discovery of Therapeutic Targets
Meniere's Disease, Enlarged Vestibular Aqueduct Syndrome
RecruitingPhase 4
Treatment of Meniere's Disease With Migraine Medications
Ménière
RecruitingPhase 2
Effects of Anakinra in Subjects With Corticosteroid-resistant/Intolerant Meniere's Disease and Autoimmune Inner Ear Disease
Autoimmune Inner Ear Disease, Meniere's Disease

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. This study is not recruiting at the moment.

Habib Rizk, MD principal investigator

Medical University of South Carolina

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Venlafaxine in people with Meniere Disease, run by Medical University of South Carolina 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?

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: finished, as of the sponsor's last update on 23 Jul 2024. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Vertigo Episodes (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04218123, which also lists 1 linked publication.

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 23 Jul 2024.