The Role of Migraine Prophylaxis Agent Topiramate in Treating Patients With Sudden Sensorineural Hearing Loss
Primary Purpose
Sudden Deafness, Sudden Sensorineural Hearing Loss
Status
Recruiting
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Topiramate
Systemic Steroids
Sponsored by
About this trial
This is an interventional treatment trial for Sudden Deafness focused on measuring sudden deafness, SSNHL, migraine, topiramate, sudden sensorineural hearing loss
Eligibility 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
Sites / Locations
- New Taipei Municipal Tucheng HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Topiramate arm
Control arm
Arm Description
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.
The control arm receives a systemic steroid with/without intratympanic steroids as the standard treatment of SSNHL.
Outcomes
Primary Outcome Measures
Audiometry change
The improvement rate and gain of pure tone audiometry (compare day 0 and day 84)
Secondary Outcome Measures
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)
Full Information
NCT ID
NCT05403229
First Posted
May 20, 2022
Last Updated
October 28, 2022
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05403229
Brief Title
The Role of Migraine Prophylaxis Agent Topiramate in Treating Patients With Sudden Sensorineural Hearing Loss
Official Title
The Role of Migraine Prophylaxis Agent Topiramate in Treating Patients With Sudden Sensorineural Hearing Loss
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 17, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sudden Deafness, Sudden Sensorineural Hearing Loss
Keywords
sudden deafness, SSNHL, migraine, topiramate, sudden sensorineural hearing loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Participants are assigned to one of two groups in parallel for the duration of the study.
Masking
None (Open Label)
Masking Description
This is an open-label study.
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Topiramate arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Control arm
Arm Type
Active Comparator
Arm Description
The control arm receives a systemic steroid with/without intratympanic steroids as the standard treatment of SSNHL.
Intervention Type
Drug
Intervention Name(s)
Topiramate
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Systemic Steroids
Intervention Description
Both groups receive a systemic steroid with/without intratympanic steroids as the standard treatment of SSNHL.
Primary Outcome Measure Information:
Title
Audiometry change
Description
The improvement rate and gain of pure tone audiometry (compare day 0 and day 84)
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.
Secondary Outcome Measure Information:
Title
Audiometry change
Description
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)
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BANG-YAN ZHANG, MD.
Phone
886978810104
Email
bangyanzhang@cgmh.org.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BANG-YAN ZHANG, MD.
Organizational Affiliation
New Taipei Municipal TuCheng Hospital (Built and Operated by Chang Gung Medical Foundation)
Official's Role
Study Chair
Facility Information:
Facility Name
New Taipei Municipal Tucheng Hospital
City
New Taipei City
ZIP/Postal Code
236
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BANG-YAN ZHANG
Phone
886978810104
Email
bangyanzhang@cgmh.org.tw
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be shared under the regulation of the institution review board of Chang Gung medical foundation.
Citations:
PubMed Identifier
32243585
Citation
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.
Results Reference
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The Role of Migraine Prophylaxis Agent Topiramate in Treating Patients With Sudden Sensorineural Hearing Loss
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