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

• ClinicalTrials.gov Identifier: NCT04218123
• Recruitment Status: Completed
• First Posted: January 6, 2020
• Last Update Posted: September 28, 2023
• Sponsor: Medical University of South Carolina
• Collaborators: American Hearing Research Foundation; Cures within Reach Foundation
• Information provided by (Responsible Party): Habib Rizk,MD, Medical University of South Carolina

Tracking Information

• First Submitted Date: December 30, 2019
• First Posted Date: January 6, 2020
• Last Update Posted Date: September 28, 2023
• Actual Study Start Date: February 5, 2020
• Actual Primary Completion Date: September 13, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 2, 2020)

• 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)

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Assessing the Efficacy of a Serotonin and Norepinephrine Reuptake Inhibitor for Improving Meniere's Disease Outcomes
• Official Title: Assessing the Efficacy of a Serotonin and Norepinephrine Reuptake Inhibitor for Improving Meniere's Disease Outcomes
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Meniere Disease

Intervention

• Drug: Venlafaxine
  Daily oral intake 37.5 mg
• Drug: Placebo oral tablet
  Daily oral intake

Study Arms

• Experimental: Venlafaxine Arm
  Intervention: Drug: Venlafaxine
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo oral tablet

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 2, 2020): 40
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: September 14, 2023
• Actual Primary Completion Date: September 13, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04218123
• Other Study ID Numbers: 00091200
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Habib Rizk,MD, Medical University of South Carolina
• Original Responsible Party: Habib Rizk,MD, Medical University of South Carolina, Assistant Professor
• Current Study Sponsor: Medical University of South Carolina
• Original Study Sponsor: Same as current

Collaborators

• American Hearing Research Foundation
• Cures within Reach Foundation

Investigators

• Principal Investigator: Habib Rizk, MD; Medical University of South Carolina

• PRS Account: Medical University of South Carolina
• Verification Date: September 2023