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| Name | Class |
|---|---|
| American Hearing Research Foundation | OTHER |
| Cures Within Reach | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venlafaxine Arm | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venlafaxine | Drug | Daily oral intake 37.5 mg |
| |
| Placebo oral tablet |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Vertigo Episodes | Patients will be keeping a diary throughout the study period and beyond. | 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) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Habib Rizk, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Univeristy of South Carolina | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39235772 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Venlafaxine, Then Placebo | Venlafaxine 37.5mg tablet by mouth once daily in first 8 week period and placebo tablet by mouth once daily in the second 8 week period. |
| FG001 | Placebo, Then Venlafaxine | Placebo tablet by mouth once daily in first 8 week period and venlafaxine 37.5mg tablet by mouth once daily in the second 8 week period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Venlafaxine, Then Placebo | Venlafaxine 37.5mg tablet by mouth once daily in first 8 week period and placebo tablet by mouth once daily in the second 8 week period. |
| BG001 | Placebo, Then Venlafaxine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Vertigo Episodes | Patients will be keeping a diary throughout the study period and beyond. | Posted | Mean | Standard Deviation | number of episodes | 6 months |
|
22 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Venlafaxine Arm | Venlafaxine: Daily oral intake 37.5 mg | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry mouth | General disorders | Non-systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Habib Rizk, MD, MSc | Department of Otolaryngology - Head and Neck Surgery, Medical University of South Carolina | 8438760112 | rizkh@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 12, 2019 | Apr 24, 2024 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D008575 | Meniere Disease |
| ID | Term |
|---|---|
| D018159 | Endolymphatic Hydrops |
| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D000069470 | Venlafaxine Hydrochloride |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 |
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| Drug |
Daily oral intake |
|
| 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. | 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 | 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. | 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 | 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. | 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). | Baseline to end of treatment (6 months) |
Placebo tablet by mouth once daily in first 8 week period and venlafaxine 37.5mg tablet by mouth once daily in the second 8 week period.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | 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) | Posted | Number | Percentage of members in arm | 6 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline to end of treatment (6 months) |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline to end of treatment (6 months) |
|
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | score on a scale | Baseline to end of treatment (6 months) |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline to end of treatment (6 months) |
|
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | score on a scale | Baseline to end of treatment (6 months) |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline to end of treatment (6 months) |
|
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | Baseline to end of treatment (6 months) |
|
|
|
|
| 40 |
| 0 |
| 40 |
| 6 |
| 40 |
| EG001 | Placebo | Placebo oral tablet: Daily oral intake | 0 | 40 | 0 | 40 | 3 | 40 |
| Nausea/vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Decreased Appetite | General disorders | Non-systematic Assessment |
|
| Insomnia | General disorders | Non-systematic Assessment |
|
| Decreased Energy | General disorders | Non-systematic Assessment |
|
| Sweating | General disorders | Non-systematic Assessment |
|
| Weight Change | General disorders | Non-systematic Assessment |
|
| Tinnitus | Nervous system disorders | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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| Organic Chemicals |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D008055 | Lipids |
| Class C Control |
|
| Class D Control |
|
| Class E Control |
|
|
| Mental Health |
|
| Social Functioning |
|
| Health Perceptions |
|
| Pain |
|
| ANOVA |
| 0.633 |
| Equivalence |
p value of <0.05 required for result to be considered nonequivalent |
| SF20 Mental Health | ANOVA | 0.424 | Equivalence | p value of <0.05 required for result to be considered nonequivalent |
| SF20 Social Functioning | ANOVA | 0.057 | Equivalence | p value of <0.05 required for result to be considered nonequivalent |
| SF20 Health Perceptions | ANOVA | 0.296 | Equivalence | p value of <0.05 required for result to be considered nonequivalent |
| SF20 Pain | ANOVA | 0.872 | Equivalence | p value of <0.05 required for result to be considered nonequivalent |