Treatment of peripheral tinnitus following traumatic cochlear injury or otitis media MedDRA version: 19.0 Level: PT Classification code 10043882 Term: Tinnitus System Organ Class: 10013993 - Ear and labyrinth disorders
Conditions
Sponsors
Auris Medical AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A subject will be eligible for this study if all of the following criteria apply: 1. Attendance of the final visit FUV3 of study AM-101-CL-12-02 (TACTT3); TV1 of AMPACT2 should preferably be conducted within 48 hours of FUV3 of TACTT3, but no later than 14 days thereafter. 2. Negative urine pregnancy test for women of childbearing potential; Women are not considered to be of childbearing potential if they meet 1 of the following criteria: a. They have had a hysterectomy or tubal ligation at minimum 1 cycle prior to signing the ICF or b. They are post menopausal, defined as =1 year since their last menstrual period for women =55 years of age or =1 year since their last menstrual period and have a follicle stimulating hormone (FSH) level in menopausal range for women =65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: A subject will not be eligible for this study if any of the following criteria apply: 1. Study drug related or procedure related adverse event leading to treatment discontinuation in study AM-101-CL-12-02 (TACTT3); 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 enrolment into the openlabel study (TV1, D0), or that is ongoing or planned for the study duration; 8. Use of any other NMDA 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; 11. Subjects with diagnosed anxiety disorders, depression, bipolar disorder, schizophrenia or other significant psychiatric diseases requiring current drug treatment or subjects who required treatment in the previous TACTT3 study prior to enrolment into the open-label study (TV1, D0) for these diseases; 12. Use of any antidepressant or anti-anxiety medication in the past 2 weeks prior to enrolment into the open-label study (TV1, D0), or that is ongoing, or that is planned for the study duration unless the medication was taken in a low dose and permanently during the previous TACTT3 study prior to enrolment into the open-label study (TV1, D0), not for the treatment of tinnitus, and if the treatment will be maintained throughout the duration of the study; 13. Any clinically relevant respiratory, cardiovascular, neurological disorder (except vertigo), as determined by the Investigator; 14. Any clinically relevant abnormalities in physical examination on Day 0 (TV1, D0); 15. Women who are breast-feeding, pregnant or who are planning to become pregnant during the study; 16. Women of childbearing potential who are unwilling or unable to use an effective method of avoiding pregnancy from enrolment into the openlabel study (TV1, D0) until the end of the study (FUV3, FUV6 or FUV9). Effective methods of avoiding pregnancy are contraceptive methods with a Pearl index of less than 1 used consistently and correctly (including implantable contraceptives, injectable contraceptives, oral contraceptives, transdermal contraceptives, intrauterine devices, diaphragm with spermicide, male or female condoms with spermicide, or cervical cap, or a sterile sexual partner); 17. Involvement or planned involvement in legal action related to the present peripheral tinnitus during the course of the study; 18. Concurrent participation in another clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is the evaluation of the safety and local tolerance of up to 3 quarterly treatment cycles each with 3 repeated doses of AM-101 0.87 mg/mL1 in subjects previously treated in the scope of the TACTT3 study with either AM-101 0.87 mg/mL or placebo.;Secondary Objective: The secondary objective of the study is the assessment of the efficacy of up to 3 treatment cycles each with 3 repeated doses of AM-101 0.87 mg/mL in subjects previously treated with either AM-101 0.87 mg/mL or placebo.;Primary end point(s): Primary safety endpoint: • Occurrence of deterioration in hearing threshold = 15 dB from before the start of each treatment cycle (TV1, TV4, TV7) to the corresponding 35-day-Follow-Up Visit of the respective treatment cycle (FUV2, FUV5 or FUV8) at the average of two contiguous test frequencies in the treated ear. It will be evaluated with air and bone conduction hearing threshold values.;Timepoint(s) of evaluation of this end point: last follow-up visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary safety endpoints: • Occurrence of deterioration of hearing threshold = 15 dB from baseline to TV2, TV3, FUV1 and FUV3 at the average of two contiguous test frequencies in the treated ear. In addition from TV4 to TV5, TV6, FUV4 and FUV6 for all subjects who perform Treatment Cycle 2 and from TV7 to TV8, TV9, FUV7 and FUV9 for all subjects who perform Treatment Cycle 3. It will be evaluated with air and bone conduction hearing threshold values; • Occurrence of deterioration in hearing threshold = 15 dB at the average of two contiguous test frequencies from baseline (TV1) to FUV5 for all subjects who perform Treatment Cycles 1 and 2 and from baseline (TV1) to FUV8 for all subjects who perform Treatment Cycles 1, 2 and 3. It will be evaluated with air and bone conduction hearing threshold values; • Difference in occurrence of deterioration of hearing threshold = 15 dB from baseline (TV1) to TV2, TV3, FUV1, FUV2 and FUV3 at the average of two contiguous test frequencies between treated and untreated contralateral ear (subjects with unilaterally treated tinnitus only). In addition from TV4 to TV5, TV6, FUV4, FUV5 and FUV6 for all subjects who perform Treatment Cycle 2 and from TV7 to TV8, TV9, FUV7, FUV8 and FUV9 for all subjects who perform Treatment Cycle 3. It will be evaluated with air and bone conduction hearing threshold values; • Difference in occurrence of deterioration in hearing threshold = 15 dB from baseline (TV1) to FUV5 at the average of two contiguous test frequencies between treated and untreated contralateral ear (subjects with unilaterally treated tinnitus only) for all subjects who perform Treatment Cycles 1 and 2 and from baseline (TV1) to FUV8 for all subjects who perform Treatment Cycles 1, 2 and 3. It will be evaluated with air and bone conduction hearing threshold values; • Occurrence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs), differentiated by relatedness | — |
Countries
Austria, Belgium, Germany, Hungary, Poland, Spain, United Kingdom
Contacts
Public ContactInformation
Auris Medical AG
Outcome results
None listed