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

• Status: Recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chang Gung Memorial Hospital
• Treatments: Topiramate

Criteria

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