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

February 14, 2024 updated by: Chang Gung Memorial Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • New Taipei City, Taiwan, 236
        • Recruiting
        • New Taipei Municipal TuCheng Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Drug: Systemic Steroids
Both groups receive a systemic steroid with/without intratympanic steroids as the standard treatment of SSNHL.
Active Comparator: Control arm
The control arm receives a systemic steroid with/without intratympanic steroids as the standard treatment of SSNHL.
Drug: Systemic Steroids
Both groups receive a systemic steroid with/without intratympanic steroids as the standard treatment of SSNHL.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Audiometry change
Time Frame: 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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Audiometry change
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Study Chair: BANG-YAN ZHANG, MD., New Taipei Municipal TuCheng Hospital (Built and Operated by Chang Gung Medical Foundation)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2022

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

May 20, 2022

First Submitted That Met QC Criteria

May 30, 2022

First Posted (Actual)

June 3, 2022

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 14, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202200324A3C601

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared under the regulation of the institution review board of Chang Gung medical foundation.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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