The Role of Migraine Prophylaxis Agent Topiramate in Treating Patients With Sudden Sensorineural Hearing Loss
NCT ID: NCT05403229
Last Updated: 2024-02-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
140 participants
INTERVENTIONAL
2022-10-17
2025-09-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Topiramate arm
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.
Topiramate
The topiramate arm receives additional oral topiramate for 6 weeks. The dose of topiramate is started from 25mg orally daily with the weekly escalation of 25mg to a maximum of 100mg.
Systemic Steroids
Both groups receive a systemic steroid with/without intratympanic steroids as the standard treatment of SSNHL.
Control arm
The control arm receives a systemic steroid with/without intratympanic steroids as the standard treatment of SSNHL.
Systemic Steroids
Both groups receive a systemic steroid with/without intratympanic steroids as the standard treatment of SSNHL.
Interventions
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Topiramate
The topiramate arm receives additional oral topiramate for 6 weeks. The dose of topiramate is started from 25mg orally daily with the weekly escalation of 25mg to a maximum of 100mg.
Systemic Steroids
Both groups receive a systemic steroid with/without intratympanic steroids as the standard treatment of SSNHL.
Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of unilateral sudden sensorineural hearing loss(SSNHL)
* Treatment started 14 days within onset of SSNHL
Exclusion Criteria
* 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
20 Years
ALL
No
Sponsors
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Chang Gung Memorial Hospital
OTHER
Responsible Party
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Principal Investigators
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BANG-YAN ZHANG, MD.
Role: STUDY_CHAIR
New Taipei Municipal TuCheng Hospital (Built and Operated by Chang Gung Medical Foundation)
Locations
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New Taipei Municipal Tucheng Hospital
New Taipei City, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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202200324A3C601
Identifier Type: -
Identifier Source: org_study_id
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