The Role of Migraine Prophylaxis Agent Topiramate in Treating Patients With Sudden Sensorineural Hearing Loss
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Audiometry change
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label study.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 20
- •Confirmed diagnosis of unilateral sudden sensorineural hearing loss(SSNHL)
- •Treatment started 14 days within onset of SSNHL
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Topiramate (Drug)
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.
干预措施: Systemic Steroids (Drug)
Control arm
The control arm receives a systemic steroid with/without intratympanic steroids as the standard treatment of SSNHL.
干预措施: Systemic Steroids (Drug)
结局指标
主要结局
Audiometry change
时间窗: 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)
次要结局
- Audiometry change(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.)