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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: f
View:

• Age \> 20

• Confirmed diagnosis of unilateral sudden sensorineural hearing loss(SSNHL)

• Treatment started 14 days within onset of SSNHL

Locations
Other Locations
Taiwan
New Taipei Municipal Tucheng Hospital
RECRUITING
New Taipei City
Contact Information
Primary
BANG-YAN ZHANG, MD.
bangyanzhang@cgmh.org.tw
886978810104
Time Frame
Start Date: 2022-10-17
Estimated Completion Date: 2025-09
Participants
Target number of participants: 140
Treatments
Experimental: 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.
Active_comparator: Control arm
The control arm receives a systemic steroid with/without intratympanic steroids as the standard treatment of SSNHL.
Related Therapeutic Areas
Sponsors
Leads: Chang Gung Memorial Hospital

This content was sourced from clinicaltrials.gov