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Tricyclic Antidepressant + Anticonvulsant

Nortriptyline + Topiramate for Meniere's Disease

Phase 4

Recruiting

Research Sponsored by University of California, Irvine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

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.

Who is the study for?

This trial is for adults aged 25-85 with active or frequent Meniere's Disease who can take medication regularly and attend study visits. They must be able to read and write English to consent. Excluded are pregnant women, those with a history of surgery for Meniere's, adverse reactions to the study medications, concerning medical conditions, psychosis, neurological tumors, or contraindications preventing safe use of the drugs.Check my eligibility

What is being tested?

The trial tests if migraine medications nortriptyline and topiramate can treat Meniere's Disease symptoms like vertigo and hearing loss. There are no FDA-approved treatments for this condition yet; these drugs have shown promise in clinical practice.See study design

What are the potential side effects?

Potential side effects from nortriptyline may include dry mouth, drowsiness, dizziness while topiramate might cause weight loss, tingling sensations in limbs or face fatigue.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Meniere Disease

Secondary outcome measures

Dizziness

Meniere Disease

Patient Health Questionnaire (PHQ)

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: nortriptyline + topiramateExperimental Treatment1 Intervention

Nortriptyline (starting dose 7.5 mg) plus Topiramate (starting dose 10 mg) with appropriate dosage increase as necessary

Group II: hydrochlorothiazide + triamterene + placeboActive Control1 Intervention

hydrochlorothiazide (starting dose 25 mg) plus triamterene (starting dose 37.5 mg) with placebo being added in case of a dosage increase

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of California, IrvineLead Sponsor

544 Previous Clinical Trials

1,922,943 Total Patients Enrolled

Media Library

nortriptyline + topiramate (Tricyclic Antidepressant + Anticonvulsant) Clinical Trial Eligibility Overview. Trial Name: NCT05582837 — Phase 4

Ménière's Disease Research Study Groups: nortriptyline + topiramate, hydrochlorothiazide + triamterene + placebo

Ménière's Disease Clinical Trial 2023: nortriptyline + topiramate Highlights & Side Effects. Trial Name: NCT05582837 — Phase 4

nortriptyline + topiramate (Tricyclic Antidepressant + Anticonvulsant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05582837 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

How many prior treatments have patients received?

What site did they apply to?

University of California, Irvine Medical Center ENT Clinic (Pavilion 2)

Why did patients apply to this trial?

My ENT believes I have a combination of Meniers and vestibular migraines. Nothing really seems to work so I am open to these kinds of research. I may help me and it may help others.

PatientReceived no prior treatments

Recent research and studies

clinicaltrials.govStudy

Treatment of Meniere's Disease With Migraine Medications

Hamid Djalilian 2022. "Treatment of Meniere's Disease With Migraine Medications". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05582837.

All > Migraine