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NCT05582837 · ClinicalTrials.gov registry record · Phase 4
Treatment of Meniere's Disease With Migraine Medications
A Phase 4 study of Ménière, sponsored by University of California, Irvine.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT05582837: Recruiting Phase 4 study of Ménière, sponsored by University of California, Irvine.
NCT05582837 is a Phase 4 study of Ménière that is actively recruiting participants, run by University of California, Irvine. The registered enrollment target is 100 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05582837, a Phase 4 study of Ménière, is actively recruiting participants, sponsored by University of California, Irvine.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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 o
Conditions Studied
Interventions
- DRUG nortriptyline + topiramate
Study Locations (1)
California
- University of California, Irvine Medical Center ENT Clinic (Pavilion 2) - Orange
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2022-08-01 |
| Est. Completion | 2026-12-30 |
| Phase | Phase 4 |
What NCT05582837 shows while recruiting
NCT05582837 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Ménière appearing as the primary indexed condition, and to 1 intervention - of which nortriptyline + topiramate is the first listed.
NCT05582837 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05582837 about?
NCT05582837 is a clinical study titled "Treatment of Meniere's Disease With Migraine Medications". 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 dist...
What is the current status of trial NCT05582837?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2022-08-01. Estimated completion is 2026-12-30.
What conditions does trial NCT05582837 study?
This clinical trial studies the following conditions: Ménière.
What interventions are being tested in trial NCT05582837?
The interventions under investigation include: nortriptyline + topiramate (DRUG).
Who is sponsoring clinical trial NCT05582837?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05582837 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05582837's enrollment target sits among peer trials
100 770th of 2000 higher than 1,149 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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