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NCT04218123 · ClinicalTrials.gov registry record · Phase 2
Assessing the Efficacy of a Serotonin and Norepinephrine Reuptake Inhibitor for Improving Meniere's Disease Outcomes
A Phase 2 study of Meniere Disease, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT04218123: Completed Phase 2 study of Meniere Disease, sponsored by Medical University of South Carolina.
NCT04218123 is a Phase 2 study of Meniere Disease that has completed, run by Medical University of South Carolina. The registered enrollment target is 40 participants, below the 103-participant average among 3 other Meniere Disease trials with a reported enrollment target (61% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04218123, a Phase 2 study of Meniere Disease, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Patients will be keeping a diary throughout the study period and beyond.
Conditions Studied
Interventions
- DRUG Placebo oral tablet
- DRUG Venlafaxine
Study Locations (1)
South Carolina
- Medical Univeristy of South Carolina - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2020-02-05 |
| Est. Completion | 2023-09-14 |
| Phase | Phase 2 |
What the finished NCT04218123 record still lists
NCT04218123 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 103-participant average among 3 other Meniere Disease trials with a reported enrollment target (61% lower).
The record links to 1 condition, with Meniere Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo oral tablet is the first listed.
NCT04218123 reports a single indexed study location in South Carolina.
Frequently Asked Questions
What is clinical trial NCT04218123 about?
NCT04218123 is a clinical study titled "Assessing the Efficacy of a Serotonin and Norepinephrine Reuptake Inhibitor for Improving Meniere's Disease Outcomes". 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-t...
What is the current status of trial NCT04218123?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2020-02-05. Estimated completion is 2023-09-14.
What conditions does trial NCT04218123 study?
This clinical trial studies the following conditions: Meniere Disease.
What interventions are being tested in trial NCT04218123?
The interventions under investigation include: Placebo oral tablet (DRUG), Venlafaxine (DRUG).
Who is sponsoring clinical trial NCT04218123?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04218123 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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