The Efficacy of Incobotulinum Toxin A Injections for Treatment of Tinnitus: a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Change in the Tinnitus Handicap Inventory score
研究概览
简要总结
Tinnitus is a persistent non-physiologic, non-psychiatric, ringing in the ear that affects up to 20% of the general US population. The purpose of this study is to assess the patient reported effectiveness of Xeomin (incobotulinumtoxinA) injections into the auricular muscles for relief of tinnitus with use of the Tinnitus Handicap Inventory questionnaire.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults age 18 or older
- •Unilateral or bilateral tinnitus present for ≥ 2 months
- •A score >16 on the Tinnitus Handicap Inventory
- •Participants must be willing and able to provide informed consent.
排除标准
- •Patients with known hypersensitivity to any botulinum toxin product or to any of the components in the formulation.
- •Patients who have received botulinum toxin injections for any medical reason within 4 months prior to screening.
- •Patients with infection at proposed injection sites.
- •Patients scheduled for neurological or otological surgery for chronic ear disease, vestibular schwannoma, meningioma, or skull base tumors.
- •Significant psychiatric history or associated diagnosis of major depression.
- •Women who are pregnant or breastfeeding.
研究组 & 干预措施
Incobotulinium toxin A group
Individuals with symptoms of tetanus will receive three serial injections of incobotulinum toxin A into the auricular muscles.
干预措施: incobotulinum toxin A (Drug)
Placebo
Individuals with symptoms of tetanus will receive placebo saline injections.
干预措施: Placebo-Saline (Drug)
结局指标
主要结局
Change in the Tinnitus Handicap Inventory score
时间窗: pre-injection baseline to 4-6 weeks post injection
in the group assigned to placebo for the first stage
次要结局
未报告次要终点