nortriptyline + topiramate for Ménière's Disease

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
University of California, Irvine Medical Center ENT Clinic (Pavilion 2), Orange, CAMénière's Diseasenortriptyline + topiramate - Drug
Eligibility
25 - 85
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying a new treatment for Meniere's disease, a chronic condition with symptoms like vertigo, hearing loss, tinnitus, and instability. It's hoped that this new treatment will help improve patients' quality of life.

Eligible Conditions
  • Ménière's Disease

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: 8 weeks

8 weeks
Dizziness
Meniere Disease
Patient Health Questionnaire (PHQ)
Perceived Stress Scale (PSS)
Sleep Quality Index (SQI)
Meniere Disease
Tinnitus Functional Index (TFI)
Visual analog scale (VAS)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

hydrochlorothiazide + triamterene + placebo
1 of 2
nortriptyline + topiramate
1 of 2

Active Control

Experimental Treatment

100 Total Participants · 2 Treatment Groups

Primary Treatment: nortriptyline + topiramate · No Placebo Group · Phase 4

nortriptyline + topiramate
Drug
Experimental Group · 1 Intervention: nortriptyline + topiramate · Intervention Types: Drug
hydrochlorothiazide + triamterene + placebo
Drug
ActiveComparator Group · 1 Intervention: nortriptyline + topiramate · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 8 weeks

Who is running the clinical trial?

University of California, IrvineLead Sponsor
503 Previous Clinical Trials
1,881,561 Total Patients Enrolled

Eligibility Criteria

Age 25 - 85 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have Meniere's Disease that is currently active or occurs frequently.

Frequently Asked Questions

Is there any regulatory endorsement for the combination of nortriptyline and topiramate?

"This combination of drugs is approved, as evidenced by its Phase 4 trial status; thus, it was given a safety score of 3." - Anonymous Online Contributor

Unverified Answer

For whom is this clinical research appropriate?

"This medical trial is looking to include 100 individuals who suffer from ménière between the ages of 25 and 85. It goes without saying that interested applicants must meet a few requirements, such as being compliant with medications, attending study visits, and having the ability to read and write in English for consent purposes." - Anonymous Online Contributor

Unverified Answer

Is there capacity for prospective participants in this medical experiment?

"Indeed, the clinical trial is currently accepting participants. The initial posting date was on August 1st 2022 and it has most recently been updated on October 12th of this year." - Anonymous Online Contributor

Unverified Answer

Does this trial accept applicants of twenty years or older?

"This trial has established an age range of 25 to 85 years old for prospective participants, as stipulated by the eligibility requirements." - Anonymous Online Contributor

Unverified Answer

To what extent has recruitment been successful for this research study?

"Affirmative. Information available on clinicaltrials.gov implies that this research project is currently seeking participants, having been initially posted on August 1st 2022 and most recently updated on October 12th 2022. The investigators are aiming to enrol 100 individuals from a single site." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.