TACTT2: Efficacy and Safety of AM-101 in the Treatment of Acute Peripheral Tinnitus 2
- Conditions
- Diseases of the ear and mastoid process
- Registration Number
- KCT0001477
- Lead Sponsor
- ovotech Asia Korea
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 330
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;
, etc.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in TFI(Tinnitus Functional Index) total score from baseline to FUV3 (Follow-Up Visit 3);Improvement in patient-reported tinnitus loudness TLQ(Tinnitus Loudness Question) NRS(Numerical Rating Scale)Loudest from baseline to FUV3(Follow-Up Visit 3);Occurrence of deterioration in hearing threshold = 15 dB from baseline to FUV2(Follow-Up Visit 2) at the average of two contiguous test frequencies (air conduction) in the treated ear
- Secondary Outcome Measures
Name Time Method Improvement in patient-reported tinnitus loudness TLQ(Tinnitus Loudness Question) NRS(Numerical Rating Scale)Loudest from baseline to FUV1(Follow-Up Visit 1) and FUV2(Follow-Up Visit 2);Improvement in TFI(Tinnitus Functional Index) total score from baseline to FUV1(Follow-Up Visit 1) and FUV2(Follow-Up Visit 2);Occurence and severity of adverse events and serious adverse events