NCT01302873已完成2 期
A Multicenter, Randomized, Double-blind, Placebo- Controlled, Cross-over, Proof of Concept Study Comparing the Effects of Both Single Dose and Repeated Dosing Treatment for 2 Weeks of BGG492 in Patients With Chronic Subjective Tinnitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Change in tinnitus loudness using a visual analogue scale (VAS)
研究概览
简要总结
This study will assess the efficacy of a two week treatment with BGG492 in patients with chronic subjective Tinnitus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with THI (Tinnitus Handicap Inventory) severity grade 3, 4 or 5 (moderate, severe or catastrophic), chronic (> 6 months and < 36 months) subjective tinnitus
- •Willing to abstain from activities that require focused attention, e.g. driving a car or other vehicles, operating machines or engaging in potentially dangerous activities that require focused attention and intact physical balance
- •Willing and able to refrain from engaging in activities or work involving loud noise exposure
排除标准
- •Patients diagnosed with tinnitus of THI severity grade equal to 2 or 1
- •Patients with diagnosis of intermittent or pulsatile tinnitus
- •Patients who have tinnitus as a concomitant symptom of a treatable otological disease (such as otitis media, Menière's disease, otosclerosis), neurological tumors or/and have temporo-mandibular joint disorders
- •Patients with a history of frequent middle ear infections (> 3 infections per year during the last 3 years)
- •Patients with diagnosed anxiety disorders, depression, schizophrenia or other significant psychiatric diseases requiring current drug treatment or patients who required treatment in the previous 3 months for these diseases.
- •Patients with current unilateral or bilateral hearing loss of 75 dB or more in one or more tested frequencies (125 Hz, 250 Hz, 1 kHz, 2 kHz, 4 kHz, 6 kHz, 8 kHz)
- •Patients with Vestibular Schwannoma
- •Patients with a cochlear implant
- •Patients with regular intake of central nervous system acting drugs for the treatment of tinnitus in the previous 6 months prior to initial dosing
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: BGG492A (Drug)
BGG492
Experimental
干预措施: BGG492A (Drug)
结局指标
主要结局
Change in tinnitus loudness using a visual analogue scale (VAS)
时间窗: after 15 days of treatment
Change in Clinical status of tinnitus (patients' reaction to tinnitus) using the TBF-12 (Tinnitus Impairment Questionnaire)
时间窗: after 15 days of treatment
次要结局
未报告次要终点
研究者
研究点 (1)
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