Efficacy and Safety of AM-101 in the Treatment of Acute Peripheral Tinnitus 2 (TACTT2)

ovotech Asia Korea0 个研究点目标入组 330 人开始时间: 待定最近更新: 2019年3月11日

适应症

试验速览

暂无简介。

•1. Persistent subjective peripheral tinnitus (unilateral or bilateral) following traumatic cochlear injury (acute acoustic trauma, blast trauma, middle ear surgery, inner ear barotrauma, tympanic membrane trauma) or otitis media with onset no longer than 3 months prior to randomization, as documented by medical report or by documented medical history.
•2. Age = 18 years and = 75 years;
•3. Negative urine pregnancy test for women of childbearing potential;
•4. Willing and able to attend the study visits;
•5. Able to read and understand study documents, to complete the relevant questionnaires and rating scales and follow Investigator instructions;
•6. Able to understand and follow study personnel instructions during audiologic measurements;
•7. Willing and able to use adequate hearing protection, respectively to refrain from engaging in activities or work involving loud noise exposure where sufficient hearing protection is not possible or ensured;
•8. Willing and able to protect ear canal and middle ear from water exposure as long as tympanic membrane is not fully closed after IMP administration;
•9. Signed IRB/REB/IEC approved Informed Consent Form (ICF).

•1. Fluctuating tinnitus;
•2. Intermittent tinnitus;
•3. Tinnitus resulting from traumatic head or neck injury;
•4. Onset of tinnitus more than 3 months ago;
•5. Suspected or diagnosed Meniere’s Disease, history of endolymphatic hydrops, or history of fluctuating hearing loss;
•6. History of repeated idiopathic sudden sensorineural hearing loss (defined as at least two events of ISSNHL in the last 24 months) or history of acoustic neuroma;
•7. Ongoing purulent acute or chronic otitis media or otitis externa;
•8. Abnormality of the tympanic membrane in the affected ear(s) that would preclude i.t. injection;
•9. Subjects with current hearing loss in the affected ear(s) of 75 dB or more in one or more test frequencies;
•10. Subjects with fluctuating hearing;

发起方

ovotech Asia Korea