None listed
Conditions
Interventions
Drug : - Drug Name: AM-101 (Prefilled syringe)
- Dosing Regimen: Subjects will receive one to three quarterly treatment cycles consisting of three injections of about 250 µL of study drug into each el
Sponsors
Novotech Asia Korea
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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).
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Difference and occurence of Deterioration of hearing threshold = 15 dB ;Occurrence and severity of adverse events and serious adverse events | — |
Countries
Korea, Republic of
Contacts
Public ContactHong Hye
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Outcome results
None listed