AMPACT1: AM-101 in the Post-Acute Treatment of Peripheral Tinnitus 1(AMPACT1) – an open-label extension to the TACTT2 study
- Conditions
- Diseases of the ear and mastoid process
- Registration Number
- KCT0001511
- Lead Sponsor
- ovotech Asia Korea
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 330
1. Attendance of the final visit FUV3(Follow-Up Visit 3) of study AM-101-CL-12-01 (TACTT2);
TV1(Treatment Visit 1) of AMPACT1 should preferably be conducted within 48 hours of FUV3(Follow-Up Visit 3) of TACTT2, but no later than 14 days thereafter;
2. Negative urine pregnancy test for women of childbearing potential;
3. Willing and able to attend the study visits during at least one treatment cycle;
4. Able to read and understand study documents, to complete the relevant questionnaires and rating scales and follow Investigator instructions;
5. Able to understand and follow study personnel instructions during audiologic measurements;
6. 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;
7. 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;
8. Signed IRB(Institutional Review Board)/REB(Research Ethics Board)/IEC(Independent Ethics Committee) approved Informed Consent Form (ICF).
1. Study drug related or procedure related adverse event leading to treatment discontinuation in study AM-101-CL-12-01 (TACTT2);
2. Suspected or diagnosed Meniere’s Disease, endolymphatic hydrops, acoustic neuroma or history of fluctuating hearing loss;
3. Ongoing purulent acute or chronic otitis media or otitis externa;
4. Abnormality of the tympanic membrane in the affected ear(s) that would preclude i.t. injection;
5. Subjects with current hearing loss in the affected ear(s) of 75 dB or more in one or more test frequencies (250 Hz, 500 Hz, 1 kHz, 2 kHz, 3 kHz, 4 kHz, 6 kHz, 8 kHz);
6. Any ongoing drug-based therapy for otitis media or otitis externa;
7. Any drug-based therapy known as potentially tinnitus-inducing (e.g. aminoglycosides, cisplatin, loop diuretics, high doses of aspirin [>2 g /day] or quinine) in the past 2 weeks prior to enrollment into the open-label study (TV1(Treatment Visit 1), Day 0), or that is ongoing or planned for the study duration;
8. Use of any other NMDA(N-Methyl-D-Aspartate) receptor antagonist (e.g. memantine, dextromethorphan) that is planned for
the study duration;
9. Any planned pharmacological or non-pharmacological treatment of tinnitus for the study duration;
10. History within the past two years or presence of drug abuse or alcoholism;
, etc.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Occurrence of deterioration in hearing threshold(= 15 dB) from before the start of each treatment cycle to the corresponding 35-day-Follow-Up Visit of the respective treatment cycle
- Secondary Outcome Measures
Name Time Method Difference and occurence of Deterioration of hearing threshold = 15 dB ;Occurrence and severity of adverse events and serious adverse events