Trial · NCT04218123
Assessing the Efficacy of a Serotonin and Norepinephrine Reuptake Inhibitor for Improving Meniere's Disease Outcomes
NCT04218123, Phase 2, Phase 3, Completed, Medical University of South Carolina; results first posted 2024-06-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Assessing the Efficacy of a Serotonin and Norepinephrine Reuptake Inhibitor for Improving Meniere's Disease Outcomes. Trials, record NCT04218123. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04218123
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Assessing the Efficacy of a Serotonin and Norepinephrine Reuptake Inhibitor for Improving Meniere's Disease Outcomes
- NCT number
- NCT04218123
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 40 participants, actual
- Lead sponsor
- Medical University of South Carolina
- Conditions
- Meniere Disease
- Interventions
- Venlafaxine, Placebo oral tablet
- First posted
- 2020-01-06
- Last updated
- 2024-07-23
- Results first posted
- 2024-06-24
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Vertigo Episodes | 6 months | Patients will be keeping a diary throughout the study period and beyond. |
| Primary | Severity of Vertigo | 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) |
| Secondary | Change in Score on The Medical Outcomes Study 20-item Short Form Health Survey | Baseline to end of treatment (6 months) | 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. |
| Secondary | Change in Score on The Meniere's Disease Patient-Oriented Symptom Index (MDPOSI) | Baseline to end of treatment (6 months) | 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. |
| Secondary | Change in Score on Penn State Worry Questionnaire (PSWQ) | Baseline to end of treatment (6 months) | 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 |
| Secondary | Change in Score on Patient Health Questionnaire (PHQ9) | Baseline to end of treatment (6 months) | 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. |
| Secondary | Change in Score on Cognitive Failure Questionnaire (CFQ) | Baseline to end of treatment (6 months) | 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 |
| Secondary | Change in Score on Neuropsychological Vertigo Inventory (NVI) | Baseline to end of treatment (6 months) | 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. |
| Secondary | Change in Score on Dizziness Handicap Inventory (DHI) | Baseline to end of treatment (6 months) | 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). |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Vertigo Episodes | 6 months | number of episodes | MEAN | |
| PRIMARY | Severity of Vertigo | 6 months | Percentage of members in arm | NUMBER | |
| SECONDARY | Change in Score on The Medical Outcomes Study 20-item Short Form Health Survey | Baseline to end of treatment (6 months) | score on a scale | MEAN | |
| SECONDARY | Change in Score on The Meniere's Disease Patient-Oriented Symptom Index (MDPOSI) | Baseline to end of treatment (6 months) | score on a scale | MEAN | |
| SECONDARY | Change in Score on Penn State Worry Questionnaire (PSWQ) | Baseline to end of treatment (6 months) | score on a scale | MEAN | |
| SECONDARY | Change in Score on Patient Health Questionnaire (PHQ9) | Baseline to end of treatment (6 months) | score on a scale | MEAN | |
| SECONDARY | Change in Score on Cognitive Failure Questionnaire (CFQ) | Baseline to end of treatment (6 months) | score on a scale | MEAN | |
| SECONDARY | Change in Score on Neuropsychological Vertigo Inventory (NVI) | Baseline to end of treatment (6 months) | score on a scale | MEAN | |
| SECONDARY | Change in Score on Dizziness Handicap Inventory (DHI) | Baseline to end of treatment (6 months) | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group49
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Vertigo Episodes | Venlafaxine Arm | 5.41 | Standard Deviation 4.44 | number of episodes | |
| Number of Vertigo Episodes | Placebo Arm | 5.03 | Standard Deviation 4.57 | number of episodes | |
| Number of Vertigo Episodes | Baseline Score | 13.78 | Standard Deviation 10.05 | number of episodes | |
| Severity of Vertigo | Venlafaxine Arm | Class A Control | 16 | Percentage of members in arm | |
| Severity of Vertigo | Placebo | Class A Control | 24 | Percentage of members in arm | |
| Severity of Vertigo | Venlafaxine Arm | Class B Control | 38 | Percentage of members in arm | |
| Severity of Vertigo | Placebo | Class B Control | 32 | Percentage of members in arm | |
| Severity of Vertigo | Venlafaxine Arm | Class C Control | 30 | Percentage of members in arm | |
| Severity of Vertigo | Placebo | Class C Control | 32 | Percentage of members in arm | |
| Severity of Vertigo | Venlafaxine Arm | Class D Control | 5 | Percentage of members in arm |
1 to 10 of 49Source ClinicalTrials.gov
See all 49 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Venlafaxine, Then Placebo | 20 | |
| Overall Study | STARTED | Placebo, Then Venlafaxine | 20 | |
| Overall Study | COMPLETED | Venlafaxine, Then Placebo | 18 | |
| Overall Study | COMPLETED | Placebo, Then Venlafaxine | 20 | |
| Overall Study | NOT COMPLETED | Venlafaxine, Then Placebo | 2 | |
| Overall Study | NOT COMPLETED | Placebo, Then Venlafaxine | 0 |
Source ClinicalTrials.gov
Adverse events18
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dry mouth | General disorders | Venlafaxine Arm | 1 | 40 | |
| other | Dry mouth | General disorders | Placebo | 1 | 40 | |
| other | Nausea/vomiting | Gastrointestinal disorders | Venlafaxine Arm | 4 | 40 | |
| other | Nausea/vomiting | Gastrointestinal disorders | Placebo | 0 | 40 | |
| other | Decreased Appetite | General disorders | Venlafaxine Arm | 1 | 40 | |
| other | Decreased Appetite | General disorders | Placebo | 1 | 40 | |
| other | Insomnia | General disorders | Venlafaxine Arm | 0 | 40 | |
| other | Insomnia | General disorders | Placebo | 1 | 40 | |
| other | Decreased Energy | General disorders | Venlafaxine Arm | 0 | 40 | |
| other | Decreased Energy | General disorders | Placebo | 1 | 40 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Venlafaxine Arm | 0 | 40 |
| Total, all-cause mortality | Placebo | 0 | 40 |
| Total, other adverse events | Venlafaxine Arm | 6 | 40 |
| Total, other adverse events | Placebo | 3 | 40 |
| Total, serious adverse events | Venlafaxine Arm | 0 | 40 |
| Total, serious adverse events | Placebo | 0 | 40 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39235772 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Venlafaxine Arm vs Placebo: deaths from any cause | Trial comparisons |
| Venlafaxine Arm vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04218123
GET https://conductscience.org/api/trials/v1/NCT04218123/results?page=2