The Role of Migraine Prophylaxis Agent Topiramate in Treating Patients With Sudden Sensorineural Hearing Loss
1 other identifier
interventional
140
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2022
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2022
CompletedFirst Posted
Study publicly available on registry
June 3, 2022
CompletedStudy Start
First participant enrolled
October 17, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedFebruary 16, 2024
February 1, 2024
2.5 years
May 20, 2022
February 14, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Audiometry change
The improvement rate and gain of pure tone audiometry (compare day 0 and day 84)
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 (1)
Audiometry change
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.
Study Arms (2)
Topiramate arm
EXPERIMENTALThe 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.
Control arm
ACTIVE COMPARATORThe control arm receives a systemic steroid with/without intratympanic steroids as the standard treatment of SSNHL.
Interventions
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.
Both groups receive a systemic steroid with/without intratympanic steroids as the standard treatment of SSNHL.
Eligibility Criteria
You may qualify if:
- Age \> 20
- Confirmed diagnosis of unilateral sudden sensorineural hearing loss(SSNHL)
- Treatment started 14 days within onset of SSNHL
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New Taipei Municipal Tucheng Hospital
New Taipei City, 236, Taiwan
Related Publications (1)
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.
PMID: 32243585BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
BANG-YAN ZHANG, MD.
New Taipei Municipal TuCheng Hospital (Built and Operated by Chang Gung Medical Foundation)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- This is an open-label study.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2022
First Posted
June 3, 2022
Study Start
October 17, 2022
Primary Completion
May 1, 2025
Study Completion
September 1, 2025
Last Updated
February 16, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share
IPD will not be shared under the regulation of the institution review board of Chang Gung medical foundation.