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

  • STATUS
    Recruiting
  • End date
    Sep 20, 2023
  • participants needed
    250
  • sponsor
    Chang Gung Memorial Hospital
Updated on 20 June 2022
sensorineural hearing loss
hard of hearing
audiogram

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.

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.

Details
Condition Sudden Deafness
Treatment Topiramate, Systemic Steroids
Clinical Study IdentifierNCT05403229
SponsorChang Gung Memorial Hospital
Last Modified on20 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

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
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