Assessing the Efficacy of a Serotonin and Norepinephrine Reuptake Inhibitor for Improving Meniere's Disease Outcomes
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04218123|
Recruitment Status : Recruiting
First Posted : January 6, 2020
Last Update Posted : January 11, 2021
|Condition or disease||Intervention/treatment||Phase|
|Meniere Disease||Drug: Venlafaxine Drug: Placebo oral tablet||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Assessing the Efficacy of a Serotonin and Norepinephrine Reuptake Inhibitor for Improving Meniere's Disease Outcomes|
|Actual Study Start Date :||February 5, 2020|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||March 31, 2022|
|Experimental: Venlafaxine Arm||
Daily oral intake 37.5 mg
|Placebo Comparator: Placebo||
Drug: Placebo oral tablet
Daily oral intake
- Change in Score on Dizziness Handicap Inventory (DHI) [ Time Frame: 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).
- Change in Score on Neuropsychological Vertigo Inventory (NVI) [ Time Frame: 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.
- Change in Score on Cognitive Failure Questionnaire (CFQ) [ Time Frame: 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
- Change in Score on Patient Health Questionnaire (PHQ9) [ Time Frame: 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.
- Change in Score on Penn State Worry Questionnaire (PSWQ) [ Time Frame: 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
- Change in Score on The Meniere's Disease Patient-Oriented Symptom Index (MDPOSI) [ Time Frame: 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.
- Change in Score on The Medical Outcomes Study 20-item Short Form Health Survey [ Time Frame: 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. Scores range between 0 and 100, with 100 indicating best possible function and 0 the worst possible function
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04218123
|Contact: Habib Rizk, MDemail@example.com|
|Contact: Yuan Liu, MDfirstname.lastname@example.org|
|United States, South Carolina|
|Medical Univeristy of South Carolina||Recruiting|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||Habib Rizk, MD||Medical University of South Carolina|