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

Sudden Sensorineural Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05403229
• Other study ID #: 202200324A3C601
• Status: Recruiting
• Phase: Phase 2
• Start date: October 17, 2022
• Est. completion date: September 2025

Study information

• Verified date: February 2024
• Source: Chang Gung Memorial Hospital
• Contact: BANG-YAN ZHANG, MD.
• Phone: 886978810104
• Email: bangyanzhang[@]cgmh.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: September 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Sensorineural
• Hearing Loss, Sudden
• Migraine Disorders
• Sudden Deafness
• Sudden Sensorineural Hearing Loss

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Taiwan	New Taipei Municipal Tucheng Hospital	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Audiometry change	The improvement rate and gain of word recognition score (compare day 0 and day 84). The improvement rate and gain of pure tone audiometry (compare day 0 and day 56)	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.