Sudden DeafnessPhase 2NCT05403229
The Role of Migraine Prophylaxis Agent Topiramate in Treating Patients With Sudden Sensorineural Hearing Loss
A Phase 2 study testing Topiramate and Systemic Steroids in people with Sudden Deafness and Sudden Sensorineural Hearing Loss, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Sudden Deafness, Sudden Sensorineural Hearing Loss
- What is being tested?
- Topiramate and Systemic Steroids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Oct 2022to Sep 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 20
- Confirmed diagnosis of unilateral sudden sensorineural hearing loss(SSNHL)
- Treatment started 14 days within onset of SSNHL
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
New Taipei Municipal Tucheng Hospital
New Taipei City, 236
BANG-YAN ZHANG, 886978810104, bangyanzhang@cgmh.org.tw
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Sudden Deafness, Sudden Sensorineural Hearing Loss
- Being tested
- Topiramate, Systemic Steroids
- Keywords
- sudden deafness, SSNHL, migraine, topiramate, sudden sensorineural hearing loss
- Medical subject headings
- Hearing Loss, Sudden, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TopiramateDrug
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 SteroidsDrug
Both groups receive a systemic steroid with/without intratympanic steroids as the standard treatment of SSNHL.
| Study group | Role | What they receive |
|---|---|---|
| Topiramate arm | Experimental | 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. Receives: Drug: Topiramate; Drug: Systemic Steroids |
| Control arm | Active comparator | The control arm receives a systemic steroid with/without intratympanic steroids as the standard treatment of SSNHL. Receives: Drug: Systemic Steroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Audiometry change
The improvement rate and gain of pure tone audiometry (compare day 0 and day 84)
Measured: 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 outcomes (1)
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)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start17 Oct 2022
- Primary completionMay 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sudden DeafnessStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to one of two groups in parallel for the duration of the study.
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BANG-YAN ZHANG, MD., Study chair, New Taipei Municipal TuCheng Hospital (Built and Operated by Chang Gung Medical Foundation)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05403229
- Sponsor's protocol ID
- 202200324A3C601
- Status last verified
- Feb 2024
- First submitted
- 20 May 2022
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared under the regulation of the institution review board of Chang Gung medical foundation.
Publications
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.
PubMed 32243585
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Migraine Prophylaxis Agent Topiramate in Treating Patients With Sudden Sensorineural Hearing Loss
- ClinicalTrials.gov ID
- NCT05403229
- Acronym / sponsor ID
- 202200324A3C601
- Conditions
- Sudden Deafness, Sudden Sensorineural Hearing Loss
- Keywords
- sudden deafness, SSNHL, migraine, topiramate, sudden sensorineural hearing loss
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 3 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are assigned to one of two groups in parallel for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| Topiramate arm | Experimental | Drug: Topiramate, Drug: Systemic SteroidsThe 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. |
| Control arm | Active comparator | Drug: Systemic SteroidsThe control arm receives a systemic steroid with/without intratympanic steroids as the standard treatment of SSNHL. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 20
- Confirmed diagnosis of unilateral sudden sensorineural hearing loss(SSNHL)
- Treatment started 14 days within onset of SSNHL
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TopiramateThe 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 | Topiramate arm |
| Systemic SteroidsBoth groups receive a systemic steroid with/without intratympanic steroids as the standard treatment of SSNHL. | Drug | Control arm, Topiramate arm |
Primary outcome
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)
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Background: PubMed 32243585Abouzari 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.
- Individual participant dataSharing planned: No. IPD will not be shared under the regulation of the institution review board of Chang Gung medical foundation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BANG-YAN ZHANG, MD. study chair
New Taipei Municipal TuCheng Hospital (Built and Operated by Chang Gung Medical Foundation)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Topiramate and Systemic Steroids in people with Sudden Deafness and Sudden Sensorineural Hearing Loss, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact BANG-YAN ZHANG, MD. (886978810104, bangyanzhang@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05403229, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2024.