BridgeMD
New treatment option for Ménière
Official title Treatment of Meniere's Disease With Migraine Medications
ClinicalTrials.gov ID: NCT05582837
What this study is testing
What is nortriptyline + topiramate?
nortriptyline + topiramate is an investigational medicine, given as an once-weekly, being studied as a potential treatment for ménière.
Also referred to as Pamelor, Topamax.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 25 to 85
You may be able to join if
- 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.
You likely can't join if
- Pregnancy will result in automatic exclusion from the study. A urine pregnancy test to rule out pregnancy for all women who are of childbearing...
- people 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.
- people with psychosis.
- people with neurological neoplasm.
See the full eligibility 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.
- 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.
- people 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.
- people with psychosis.
- people with neurological neoplasm.
- All contraindications for the medications which prevent people from randomization will be considered as exclusion criteria.
The study team makes the final eligibility decision.
Where it's taking place
- Orange, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 25 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orange, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.