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

Chang Gung Medical Foundation

Status and phase: Enrolling; Phase 2

Conditions: Sudden Sensorineural Hearing Loss; Sudden Deafness

Treatments: Drug: Systemic Steroids; Drug: Topiramate

Study type: Interventional

Funder types: Other

Identifiers

NCT05403229

202200324A3C601

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Topiramate arm

Experimental group

Description:

The experimental group receives a systemic steroid with/without intratympanic steroids as the standard treatment of SSNHL. The experimental group receives additional oral topiramate for 6 weeks. The dosage of topiramate is 25 mg orally before bedtime with the weekly escalation of 25 mg up to 100 mg. The total duration of oral topiramate is 6 weeks.

Treatment:

Drug: Systemic Steroids

Drug: Topiramate

Control arm

Active Comparator group

Description:

The control arm receives a systemic steroid with/without intratympanic steroids as the standard treatment of SSNHL.

Treatment:

Drug: Systemic Steroids