Back to resultsTreatment of Meniere's Disease With Migraine Medications
Primary Purpose
Ménière
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
nortriptyline + topiramate
Sponsored by
About this trial
This is an interventional treatment trial for Ménière focused on measuring Meniere's Disease, medication, randomized, trial, migraine
Eligibility Criteria
Inclusion Criteria:
- Patients with active or frequent Meniere's Disease.
- Male or female between the ages of 25 to 85 years.
- Subject must be compliant with the medication and attend study visits.
- Must be able to read and write in the English language to provide consenting.
Exclusion Criteria:
- Pregnancy will result in automatic exclusion from the study. A urine pregnancy test to rule out pregnancy for all women who are of childbearing potential.
- Subjects with history of surgery for Meniere's Disease.
- Subject with history of an adverse reaction to medication being prescribed.
- Subject suffers from a medical condition or has history that may be concerning to the investigator's clinical opinion.
- Subjects with psychosis.
- Subjects with neurological neoplasm.
- All contraindications for the medications which prevent subjects from randomization will be considered as exclusion criteria.
Sites / Locations
- University of California, Irvine Medical Center ENT Clinic (Pavilion 2)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
nortriptyline + topiramate
hydrochlorothiazide + triamterene + placebo
Arm Description
Nortriptyline (starting dose 7.5 mg) plus Topiramate (starting dose 10 mg) with appropriate dosage increase as necessary
hydrochlorothiazide (starting dose 25 mg) plus triamterene (starting dose 37.5 mg) with placebo being added in case of a dosage increase
Outcomes
Primary Outcome Measures
Subjective improvement of Meniere's Disease
The primary outcome variable is derived from the validated Meniere's Disease Outcome Questionnaire (MDOQ) with 18 multiple-choice questions to compare quality of life before and after treatment. The question multiple choices are rated on a scale from 0 to 4 where the higher score indicates the higher quality of life. For each patient, the sum of his/her answers is divided (and x100) by the maximum possible scores for the pre-treatment questions and the post-treatment questions, separately. The outcome measure is the absolute change from pre- to post-treatment scores. Two-sample t test will be used to compare the outcome variable between the two treatment groups.
Secondary Outcome Measures
Visual analog scale (VAS)
Subjective improvement in tinnitus loudness severity based on a visual analog scale (VAS). The VAS is scored from 0 to 10, with a higher score representing an increased severity of tinnitus.
Perceived Stress Scale (PSS)
Subjective improvement in stress based on perceived stress scale (PSS). The PSS is scored from 0 to 40, with higher scores indicating higher perceived stress.
Sleep Quality Index (SQI)
Subjective improvement in sleep quality based on sleep quality index (SQI). The SQI is scored from 0 to 21, with higher scores indicating worse quality of sleep.
Dizziness handicap index (DHI)
Subjective improvement in dizziness handicap index (DHI). There is a maximum score of 100 (28 points for physical, 36 points for emotional and 36 points for functional) and a minimum score of 0. The higher the score, the greater the perceived handicap due to dizziness.
Tinnitus Functional Index (TFI)
Subjective improvement from baseline in tinnitus symptoms as measured by Tinnitus Functional Index (TFI). The TFI is scored from 0% to 100%, with higher scores indicating a more negative impact of tinnitus.
Meniere's Disease Outcomes Questionnaire (MDOQ)
Subjective improvement in Meniere's Disease Outcomes Questionnaire (MDOQ). To measure the quality of life in patients with Ménière's disease and to assess quality-of-life outcomes.
Patient Health Questionnaire (PHQ)
Subjective improvement in depression symptoms based on patient health questionnaire (PHQ). The PHQ is scored from 0 to 27, with a higher score indicating increased depression severity.
Full Information
NCT ID
NCT05582837
First Posted
October 7, 2021
Last Updated
October 12, 2022
Sponsor
University of California, Irvine
1. Study Identification
Unique Protocol Identification Number
NCT05582837
Brief Title
Treatment of Meniere's Disease With Migraine Medications
Official Title
Treatment of Meniere's Disease With Nortriptyline-Topiramate Stepwise Regimen: A Randomized Double-Blinded Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
Meniere's disease (MD) is a chronic disease with a variety of fluctuating signs and symptoms, which include vertigo, hearing loss, tinnitus (ringing noise in the ear), aural pressure (feeling of ear fullness), and disequilibrium (lack of stability). Vertigo represents one of the most common and distressing problems in MD patients, and it causes various somatic and psychological disorders that interfere with the patient's quality of life. Despite the large economic and emotional impact of symptoms in MD patients, there is no FDA-approved medication to treat this debilitating condition. As such, our objective in this study is to evaluate the therapeutic potential of novel medications in treating MD that have previously shown astonishing promise in our clinical practice.
Detailed Description
This study is 8 weeks in duration. There are two arms in the experiment: the first is nortriptyline (7.5 mg) plus topiramate (10 mg), the second is hydrochlorothiazide (25 mg) plus triamterene (37.5 mg) with placebo being added in case of a dosage increase. This is a double-blinded trial. Participants will be randomized to one arm for the duration of the trial using simple randomization with a computer-generated number. Both groups may receive dosage increases weekly if symptoms do not improve. Symptomatic survey scores from each arm will be obtained before and after treatment and weekly. An unblinded clinical researcher will also become involved with patients' treatments as they start to report changes in symptoms in order to monitor their safety and provide advice on change in dosage if patients have questions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ménière
Keywords
Meniere's Disease, medication, randomized, trial, migraine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Participants will be assigned to a study group by chance (like a coin flip) rather than by a medical decision made by the researchers. There are two arms in the study (treatment group which consists of nortriptyline + topiramate, control group which consist of hydrochlorothiazide plus triamterene with placebo), and participants enrolling in the trial will be randomly assigned in a 1:1 fashion to one of the arms. The participant will remain in the same arm for the duration of the study (8 weeks). There may be multiple participants in each arm who are undergoing the study at the same time (parallel model).
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
No masking: care provider
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
nortriptyline + topiramate
Arm Type
Experimental
Arm Description
Nortriptyline (starting dose 7.5 mg) plus Topiramate (starting dose 10 mg) with appropriate dosage increase as necessary
Arm Title
hydrochlorothiazide + triamterene + placebo
Arm Type
Active Comparator
Arm Description
hydrochlorothiazide (starting dose 25 mg) plus triamterene (starting dose 37.5 mg) with placebo being added in case of a dosage increase
Intervention Type
Drug
Intervention Name(s)
nortriptyline + topiramate
Intervention Description
nortriptyline (7.5mg) + topiramate (10mg) taken 1x per day and escalate weekly as needed for 8 weeks
Primary Outcome Measure Information:
Title
Subjective improvement of Meniere's Disease
Description
The primary outcome variable is derived from the validated Meniere's Disease Outcome Questionnaire (MDOQ) with 18 multiple-choice questions to compare quality of life before and after treatment. The question multiple choices are rated on a scale from 0 to 4 where the higher score indicates the higher quality of life. For each patient, the sum of his/her answers is divided (and x100) by the maximum possible scores for the pre-treatment questions and the post-treatment questions, separately. The outcome measure is the absolute change from pre- to post-treatment scores. Two-sample t test will be used to compare the outcome variable between the two treatment groups.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Visual analog scale (VAS)
Description
Subjective improvement in tinnitus loudness severity based on a visual analog scale (VAS). The VAS is scored from 0 to 10, with a higher score representing an increased severity of tinnitus.
Time Frame
8 weeks
Title
Perceived Stress Scale (PSS)
Description
Subjective improvement in stress based on perceived stress scale (PSS). The PSS is scored from 0 to 40, with higher scores indicating higher perceived stress.
Time Frame
8 weeks
Title
Sleep Quality Index (SQI)
Description
Subjective improvement in sleep quality based on sleep quality index (SQI). The SQI is scored from 0 to 21, with higher scores indicating worse quality of sleep.
Time Frame
8 weeks
Title
Dizziness handicap index (DHI)
Description
Subjective improvement in dizziness handicap index (DHI). There is a maximum score of 100 (28 points for physical, 36 points for emotional and 36 points for functional) and a minimum score of 0. The higher the score, the greater the perceived handicap due to dizziness.
Time Frame
8 weeks
Title
Tinnitus Functional Index (TFI)
Description
Subjective improvement from baseline in tinnitus symptoms as measured by Tinnitus Functional Index (TFI). The TFI is scored from 0% to 100%, with higher scores indicating a more negative impact of tinnitus.
Time Frame
8 weeks
Title
Meniere's Disease Outcomes Questionnaire (MDOQ)
Description
Subjective improvement in Meniere's Disease Outcomes Questionnaire (MDOQ). To measure the quality of life in patients with Ménière's disease and to assess quality-of-life outcomes.
Time Frame
8 weeks
Title
Patient Health Questionnaire (PHQ)
Description
Subjective improvement in depression symptoms based on patient health questionnaire (PHQ). The PHQ is scored from 0 to 27, with a higher score indicating increased depression severity.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with active or frequent Meniere's Disease.
Male or female between the ages of 25 to 85 years.
Subject must be compliant with the medication and attend study visits.
Must be able to read and write in the English language to provide consenting.
Exclusion Criteria:
Pregnancy will result in automatic exclusion from the study. A urine pregnancy test to rule out pregnancy for all women who are of childbearing potential.
Subjects with history of surgery for Meniere's Disease.
Subject with history of an adverse reaction to medication being prescribed.
Subject suffers from a medical condition or has history that may be concerning to the investigator's clinical opinion.
Subjects with psychosis.
Subjects with neurological neoplasm.
All contraindications for the medications which prevent subjects from randomization will be considered as exclusion criteria.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hamid R Djalilian
Phone
(800) 263-9547
Email
hdjalili@hs.uci.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mehdi Abouzari
Phone
(714) 509-6096
Email
mabouzar@hs.uci.edu
Facility Information:
Facility Name
University of California, Irvine Medical Center ENT Clinic (Pavilion 2)
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hamid R Djalilian, MD
Phone
800-263-9547
Email
hdjalili@hs.uci.edu
First Name & Middle Initial & Last Name & Degree
Mehdi Abouzari, MD, PhD
Phone
714-509-6096
Email
mabouzar@hs.uci.edu
First Name & Middle Initial & Last Name & Degree
Hamid R Djalilian, MD
First Name & Middle Initial & Last Name & Degree
Mehdi Abouzari, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
Treatment of Meniere's Disease With Migraine Medications
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