A Phase 2/3 interventional study of Venlafaxine and Placebo oral tablet in Meniere Disease, sponsored by Medical University of South Carolina. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-23.
Sponsored by Medical University of South Carolina · Phase 2/3, Interventional, and Treatment
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.
73 studies on the registry are indexed under Meniere Disease; 14 are open to participants now.
This study's enrollment of 40 is below the median of 49 across 62 interventional studies indexed under Meniere Disease.
Browse Meniere Disease studies →Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.
Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
Patients with the following will be excluded:
Drug: Venlafaxine
Drug: Placebo oral tablet
Daily oral intake 37.5 mg
Daily oral intake
Number of Vertigo Episodes
Patients will be keeping a diary throughout the study period and beyond.
Time frame: 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)
Time frame: 6 months
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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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).
Time frame: Baseline to end of treatment (6 months)
| Milestone | Venlafaxine, Then Placebo | Placebo, Then Venlafaxine |
|---|---|---|
| Started | 20 | 20 |
| Completed | 18 | 20 |
| Not completed | 2 | 0 |
Patients will be keeping a diary throughout the study period and beyond.
| number of episodes | Venlafaxine Arm | Placebo Arm | Baseline Score |
|---|---|---|---|
| Number of Vertigo Episodes | 5.41 ± 4.44 | 5.03 ± 4.57 | 13.78 ± 10.05 |
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)
| Percentage of members in arm | Venlafaxine Arm | Placebo |
|---|---|---|
| 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 |
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.
| score on a scale | Venlafaxine Arm | Placebo Arm | Baseline Score |
|---|---|---|---|
| Physical Functioning | 14.92 ± 3.34 | 14.54 ± 3.42 | 13.81 ± 3.6 |
| Role Functioning | 4.62 ± 1.62 | 4.6 ± 1.61 | 4.38 ± 1.52 |
| Mental Health | 22.24 ± 6.79 | 22 ± 5.95 | 20.95 ± 6.06 |
| Social Functioning | 4.38 ± 1.67 | 4.54 ± 1.44 | 3.84 ± 1.44 |
| Health Perceptions | 16.95 ± 4.91 | 16.17 ± 5.46 | 15.07 ± 5.1 |
| Pain | 2.6 ± 1.44 | 2.74 ± 1.42 | 2.76 ± 1.52 |
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.
| score on a scale | Venlafaxine Arm | Placebo Arm | Baseline Score |
|---|---|---|---|
| Change in Score on The Meniere's Disease Patient-Oriented Symptom Index (MDPOSI) | 46.81 ± 15.59 | 46.31 ± 16.32 | 50.68 ± 13.66 |
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
| score on a scale | Venlafaxine Arm | Placebo Arm | Baseline Score |
|---|---|---|---|
| Change in Score on Penn State Worry Questionnaire (PSWQ) | 44.35 ± 14.36 | 45.63 ± 13.48 | 47.16 ± 14.11 |
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.
| score on a scale | Venlafaxine Arm | Placebo Arm | Baseline Score |
|---|---|---|---|
| Change in Score on Patient Health Questionnaire (PHQ9) | 5.49 ± 5.27 | 7.17 ± 5.73 | 7.43 ± 5.32 |
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
| score on a scale | Venlafaxine Arm | Placebo Arm | Baseline Score |
|---|---|---|---|
| Change in Score on Cognitive Failure Questionnaire (CFQ) | 33.92 ± 16.35 | 36.4 ± 17.63 | 36.14 ± 18.18 |
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.
| score on a scale | Venlafaxine Arm | Placebo Arm | Baseline Score |
|---|---|---|---|
| Change in Score on Neuropsychological Vertigo Inventory (NVI) | 59.41 ± 18.67 | 63.31 ± 17.78 | 65.11 ± 20.01 |
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).
| score on a scale | Venlafaxine Arm | Placebo Arm | Baseline Score |
|---|---|---|---|
| Change in Score on Dizziness Handicap Inventory (DHI) | 45.46 ± 24.2 | 45.2 ± 20.77 | 55.62 ± 16.73 |
Collected over 22 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Venlafaxine Arm | 0/40 (0%) | 0/40 (0%) | 6/40 (15%) |
| Placebo | 0/40 (0%) | 0/40 (0%) | 3/40 (7.5%) |
| Event | Venlafaxine Arm | Placebo |
|---|---|---|
| Nausea/vomitingGastrointestinal disorders | 4/40 | 0/40 |
| Dry mouthGeneral disorders | 1/40 | 1/40 |
| Decreased AppetiteGeneral disorders | 1/40 | 1/40 |
| InsomniaGeneral disorders | 0/40 | 1/40 |
| Decreased EnergyGeneral disorders | 0/40 | 1/40 |
| SweatingGeneral disorders | 1/40 | 1/40 |
| Weight ChangeGeneral disorders | 0/40 | 1/40 |
| TinnitusNervous system disorders | 0/40 | 1/40 |
| AlopeciaSkin and subcutaneous tissue disorders | 1/40 | 0/40 |
| Age, Continuous(years) | Venlafaxine, Then Placebo | Placebo, Then Venlafaxine | Total |
|---|---|---|---|
| Mean | 54.9 ± 17.2 | 58.3 ± 11 | 56.6 ± 14.3 |
| Sex: Female, Male(Participants) | Venlafaxine, Then Placebo | Placebo, Then Venlafaxine | Total |
|---|---|---|---|
| Female | 9 | 9 | 18 |
| Male | 11 | 11 | 22 |
| Race (NIH/OMB)(Participants) | Venlafaxine, Then Placebo | Placebo, Then Venlafaxine | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 5 | 7 |
| White | 17 | 15 | 32 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Venlafaxine, Then Placebo | Placebo, Then Venlafaxine | Total |
|---|---|---|---|
| United States | 20 | 20 | 40 |
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Medical University of South Carolina