The Role of Migraine Prophylaxis Agent Topiramate in Treating Patients With Sudden Sensorineural Hearing Loss

Last updated: February 14, 2024
Sponsor: Chang Gung Memorial Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Hearing Loss

Deafness

Hearing Impairment

Treatment

Topiramate

Systemic Steroids

Clinical Study ID

NCT05403229
202200324A3C601
  • Ages > 20
  • All Genders

Study Summary

Migraine and sudden sensorineural hearing loss(SSNHL) are two related disorders. A systemic steroid is usually used to treat SSNHL but the role of migraine prophylaxis medication remained unknown. Mehdi Abouzari et al. found a better improvement when combining topiramate and nortriptyline with steroids in a retrospective study. However, a prospective study with randomization is needed to elucidate the efficacy of these agents.

This is a clinical study using medication approved and currently prescribed in the clinic. The included patients were those who came to the clinic and were diagnosed with SSNHL within 14 days of onset. Those patients were asked whether they agreed to participate in this clinical trial. Patients who were diagnosed with SSNHL but were later found to be other diseases such as Meniere's disease and cerebellopontine angle will be excluded from this study.

The involved patients were randomized divided into two groups. Both groups received systemic steroids with/without intratympanic steroids. The experimental group receives additional oral topiramate for 6 weeks.

Follow-up time is at least 3 months.

This study is multi-center. Location of the study is performed at Chang gung memorial hospital Linkou branch, Taipei branch, Taoyuan branch, and New Taipei Municipal Tucheng Hospital.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age > 20
  • Confirmed diagnosis of unilateral sudden sensorineural hearing loss(SSNHL)
  • Treatment started 14 days within onset of SSNHL

Exclusion

Exclusion Criteria:

  • Previous SSNHL history
  • Previous middle ear disorder such as chronic otitis media, or previous ear surgery
  • Meniere's disease and fluctuating hearing loss patients
  • Pregnancy or trying to become pregnant
  • Leukemia, hemodialysis, and patients who received chemotherapy before.
  • Previous head and neck radiotherapy
  • cerebellopontine angle tumors such as vestibular schwannoma
  • Patients with moderate to severe hepatic insufficiency
  • Patients with major depression disorder or suicide attempt
  • Patients with glaucoma

Study Design

Total Participants: 140
Treatment Group(s): 2
Primary Treatment: Topiramate
Phase: 2
Study Start date:
October 17, 2022
Estimated Completion Date:
September 30, 2025

Study Description

Once the patients were diagnosed with SSNHL, detailed information of the clinical trial will be introduced. If the patient agreed to participate, he/she will be randomized. The experimental group receives additional oral topiramate for 6 weeks.

Both groups follow up at the clinic for at least 3 months. The pure tone audiometry and speech audiometry will be measured at the initial and end of follow-up.

Patients who were later diagnosed with cerebellopontine angle tumors, stroke, or Meniere's disease, will be excluded from this study.

The audiometry and other hearing outcomes will be analyzed at the end of the study. The treatment efficacy, and prognostic factors will be analyzed and reported. Data regarding adverse effects and drop-out will also be collected and reported.

Connect with a study center

  • New Taipei Municipal Tucheng Hospital

    New Taipei City, 236
    Taiwan

    Active - Recruiting

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