Trial Outcomes & Findings for Assessing the Efficacy of a Serotonin and Norepinephrine Reuptake Inhibitor for Improving Meniere's Disease Outcomes (NCT NCT04218123)

NCT ID: NCT04218123

Last Updated: 2024-07-23

Results Overview

Patients will be keeping a diary throughout the study period and beyond.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 40 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2024-07-23

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	20	20
Overall Study COMPLETED	18	20
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Venlafaxine, Then Placebo n=20 Participants 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.	Placebo, Then Venlafaxine n=20 Participants 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.	Total n=40 Participants Total of all reporting groups
Age, Continuous	54.9 years STANDARD_DEVIATION 17.2 • n=5 Participants	58.3 years STANDARD_DEVIATION 11 • n=7 Participants	56.6 years STANDARD_DEVIATION 14.3 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants	15 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Patients will be keeping a diary throughout the study period and beyond.

Outcome measures

Measure	Venlafaxine Arm n=40 Participants Venlafaxine 37.5 mg tablet by mouth once daily	Placebo Arm n=40 Participants Placebo tablet by mouth once daily	Baseline Score n=40 Participants Baseline score upon enrollment in the study
Number of Vertigo Episodes	5.41 number of episodes Standard Deviation 4.44	5.03 number of episodes Standard Deviation 4.57	13.78 number of episodes Standard Deviation 10.05

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Venlafaxine Arm n=40 Participants Venlafaxine 37.5 mg tablet by mouth once daily	Placebo Arm n=40 Participants Placebo tablet by mouth once daily	Baseline Score Baseline score upon enrollment in the study
Severity of Vertigo Class A Control	16 Percentage of members in arm	24 Percentage of members in arm	—
Severity of Vertigo Class B Control	38 Percentage of members in arm	32 Percentage of members in arm	—
Severity of Vertigo Class C Control	30 Percentage of members in arm	32 Percentage of members in arm	—
Severity of Vertigo Class D Control	5 Percentage of members in arm	3 Percentage of members in arm	—
Severity of Vertigo Class E Control	11 Percentage of members in arm	9 Percentage of members in arm	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Venlafaxine Arm n=40 Participants Venlafaxine 37.5 mg tablet by mouth once daily	Placebo Arm n=40 Participants Placebo tablet by mouth once daily	Baseline Score n=40 Participants Baseline score upon enrollment in the study
Change in Score on The Medical Outcomes Study 20-item Short Form Health Survey Physical Functioning	14.92 score on a scale Standard Deviation 3.34	14.54 score on a scale Standard Deviation 3.42	13.81 score on a scale Standard Deviation 3.6
Change in Score on The Medical Outcomes Study 20-item Short Form Health Survey Role Functioning	4.62 score on a scale Standard Deviation 1.62	4.6 score on a scale Standard Deviation 1.61	4.38 score on a scale Standard Deviation 1.52
Change in Score on The Medical Outcomes Study 20-item Short Form Health Survey Mental Health	22.24 score on a scale Standard Deviation 6.79	22 score on a scale Standard Deviation 5.95	20.95 score on a scale Standard Deviation 6.06
Change in Score on The Medical Outcomes Study 20-item Short Form Health Survey Social Functioning	4.38 score on a scale Standard Deviation 1.67	4.54 score on a scale Standard Deviation 1.44	3.84 score on a scale Standard Deviation 1.44
Change in Score on The Medical Outcomes Study 20-item Short Form Health Survey Health Perceptions	16.95 score on a scale Standard Deviation 4.91	16.17 score on a scale Standard Deviation 5.46	15.07 score on a scale Standard Deviation 5.1
Change in Score on The Medical Outcomes Study 20-item Short Form Health Survey Pain	2.6 score on a scale Standard Deviation 1.44	2.74 score on a scale Standard Deviation 1.42	2.76 score on a scale Standard Deviation 1.52

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Venlafaxine Arm n=40 Participants Venlafaxine 37.5 mg tablet by mouth once daily	Placebo Arm n=40 Participants Placebo tablet by mouth once daily	Baseline Score n=40 Participants Baseline score upon enrollment in the study
Change in Score on The Meniere's Disease Patient-Oriented Symptom Index (MDPOSI)	46.81 score on a scale Standard Deviation 15.59	46.31 score on a scale Standard Deviation 16.32	50.68 score on a scale Standard Deviation 13.66

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Venlafaxine Arm n=40 Participants Venlafaxine 37.5 mg tablet by mouth once daily	Placebo Arm n=40 Participants Placebo tablet by mouth once daily	Baseline Score n=40 Participants Baseline score upon enrollment in the study
Change in Score on Penn State Worry Questionnaire (PSWQ)	44.35 score on a scale Standard Deviation 14.36	45.63 score on a scale Standard Deviation 13.48	47.16 score on a scale Standard Deviation 14.11

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Venlafaxine Arm n=40 Participants Venlafaxine 37.5 mg tablet by mouth once daily	Placebo Arm n=40 Participants Placebo tablet by mouth once daily	Baseline Score n=40 Participants Baseline score upon enrollment in the study
Change in Score on Patient Health Questionnaire (PHQ9)	5.49 score on a scale Standard Deviation 5.27	7.17 score on a scale Standard Deviation 5.73	7.43 score on a scale Standard Deviation 5.32

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Venlafaxine Arm n=40 Participants Venlafaxine 37.5 mg tablet by mouth once daily	Placebo Arm n=40 Participants Placebo tablet by mouth once daily	Baseline Score n=40 Participants Baseline score upon enrollment in the study
Change in Score on Cognitive Failure Questionnaire (CFQ)	33.92 score on a scale Standard Deviation 16.35	36.4 score on a scale Standard Deviation 17.63	36.14 score on a scale Standard Deviation 18.18

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Venlafaxine Arm n=40 Participants Venlafaxine 37.5 mg tablet by mouth once daily	Placebo Arm n=40 Participants Placebo tablet by mouth once daily	Baseline Score n=40 Participants Baseline score upon enrollment in the study
Change in Score on Neuropsychological Vertigo Inventory (NVI)	59.41 score on a scale Standard Deviation 18.67	63.31 score on a scale Standard Deviation 17.78	65.11 score on a scale Standard Deviation 20.01

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Venlafaxine Arm n=40 Participants Venlafaxine 37.5 mg tablet by mouth once daily	Placebo Arm n=40 Participants Placebo tablet by mouth once daily	Baseline Score n=40 Participants Baseline score upon enrollment in the study
Change in Score on Dizziness Handicap Inventory (DHI)	45.46 score on a scale Standard Deviation 24.2	45.2 score on a scale Standard Deviation 20.77	55.62 score on a scale Standard Deviation 16.73

Adverse Events

Venlafaxine Arm

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Venlafaxine Arm n=40 participants at risk Venlafaxine: Daily oral intake 37.5 mg	Placebo n=40 participants at risk Placebo oral tablet: Daily oral intake
General disorders Dry mouth	2.5% 1/40 • 22 weeks	2.5% 1/40 • 22 weeks
Gastrointestinal disorders Nausea/vomiting	10.0% 4/40 • 22 weeks	0.00% 0/40 • 22 weeks
General disorders Decreased Appetite	2.5% 1/40 • 22 weeks	2.5% 1/40 • 22 weeks
General disorders Insomnia	0.00% 0/40 • 22 weeks	2.5% 1/40 • 22 weeks
General disorders Decreased Energy	0.00% 0/40 • 22 weeks	2.5% 1/40 • 22 weeks
General disorders Sweating	2.5% 1/40 • 22 weeks	2.5% 1/40 • 22 weeks
General disorders Weight Change	0.00% 0/40 • 22 weeks	2.5% 1/40 • 22 weeks
Nervous system disorders Tinnitus	0.00% 0/40 • 22 weeks	2.5% 1/40 • 22 weeks
Skin and subcutaneous tissue disorders Alopecia	2.5% 1/40 • 22 weeks	0.00% 0/40 • 22 weeks

Additional Information

Habib Rizk, MD, MSc

Department of Otolaryngology - Head and Neck Surgery, Medical University of South Carolina

Phone: 8438760112

Email: rizkh@musc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place