Treatment of Meniere's Disease With Migraine Medications

Conditions

• Ménière

Eligibility Criteria

Sex

ALL

Age

25 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• nortriptyline + topiramate — DRUG
  nortriptyline (7.5mg) + topiramate (10mg) taken 1x per day and escalate weekly as needed for 8 weeks

Study Details

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.

Key Dates

Start date

Aug 1, 2022

Status verified

Apr 2026

Primary completion

Dec 30, 2027

Completion

Dec 30, 2027

Study Design

Enrollment

40 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: nortriptyline + topiramate
  Nortriptyline (starting dose 7.5 mg) plus Topiramate (starting dose 10 mg) with appropriate dosage increase as necessary
• Active Comparator: hydrochlorothiazide + triamterene + placebo
  hydrochlorothiazide (starting dose 25 mg) plus triamterene (starting dose 37.5 mg) with placebo being added in case of a dosage increase

Primary Outcome Measure

Subjective improvement of Meniere's Disease [ Time Frame: 8 weeks ]

Central Contacts

• Hamid R Djalilian
  (800) 263-9547
  [email protected]
• Mehdi Abouzari
  (714) 509-6096
  [email protected]

Locations (1)

Find similar trials in Orange, CA