Using topiramate to treat sudden hearing loss
The Role of Migraine Prophylaxis Agent Topiramate in Treating Patients With Sudden Sensorineural Hearing Loss
This study is testing if adding topiramate to standard steroid treatment can help people with sudden hearing loss recover their hearing better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Chang Gung Memorial Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (New Taipei City) |
| Trial ID | NCT05403229 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy of topiramate, a migraine prophylaxis medication, in treating patients diagnosed with sudden sensorineural hearing loss (SSNHL). Patients diagnosed with SSNHL within 14 days of onset will be randomized into two groups, one receiving systemic steroids alone and the other receiving steroids plus topiramate for six weeks. Follow-up assessments will include audiometry tests to evaluate hearing outcomes and treatment efficacy over a three-month period. The study aims to clarify the potential benefits of combining topiramate with standard steroid treatment for SSNHL.
Who should consider this trial
Good fit: Ideal candidates are adults over 20 years old with a confirmed diagnosis of unilateral sudden sensorineural hearing loss treated within 14 days of onset.
Not a fit: Patients with previous SSNHL history, other ear disorders, or specific health conditions such as Meniere's disease or major depression may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option that improves hearing recovery in patients with sudden sensorineural hearing loss.
How similar studies have performed: While previous studies have suggested potential benefits of combining topiramate with steroids, this prospective randomized trial is necessary to establish its efficacy in treating SSNHL.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New Taipei City
- New Taipei Municipal Tucheng Hospital — New Taipei City, Taiwan (Recruiting)
Study contacts
- Study coordinator: Bang-Yan Zhang, Md.
- Email: bangyanzhang@cgmh.org.tw
- Phone: 886978810104
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.