Clinical trial NCT05403229: The Role of Migraine Prophylaxis Agent Topiramate in Treating Patients With Sudden Sensorineural Hearing Loss
Official title: The Role of Migraine Prophylaxis Agent Topiramate in Treating Patients With Sudden Sensorineural Hearing Loss
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Sudden Deafness
Sudden Sensorineural Hearing Loss
Keywords: sudden deafness
SSNHL
migraine
topiramate
sudden sensorineural hearing loss
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2022-06-03
Enrollment: 140
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to one of two groups in parallel for the duration of the study.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Audiometry change
timeFrame: Baseline pure tone audiometry will be measured at the time of recruitment. The audiometry will be followed up 3 months after the initial recruitment. The audiometry change between two arms will be calculated and analyzed at the study completion.
Secondary outcomes:
measure: Audiometry change
timeFrame: The word recognition score will be measured at the time of recruitment(day 0) and end of study(day 84). The pure tone audiometry will be measured at day 56 and improvement would be calculated.
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: New Taipei Municipal Tucheng Hospital
Study officials:
affiliation: New Taipei Municipal TuCheng Hospital (Built and Operated by Chang Gung Medical Foundation)
name: BANG-YAN ZHANG, MD.
role: STUDY_CHAIR
References:
citation: Abouzari M, Goshtasbi K, Chua JT, Tan D, Sarna B, Saber T, Lin HW, Djalilian HR. Adjuvant Migraine Medications in the Treatment of Sudden Sensorineural Hearing Loss. Laryngoscope. 2021 Jan;131(1):E283-E288. doi: 10.1002/lary.28618. Epub 2020 Apr 3.