Tinnitus
Conditions
Brief summary
The purpose of this research study is to test the safety and effectiveness of the study drug, AM-101. AM-101 is tested for the treatment of tinnitus that started as the result of an injury to the inner ear or due to middle ear inflammation (otitis media). Subjects with tinnitus can take part in the study, if their tinnitus started within the last 3 months or within the last \>3 to 6 months.
Detailed description
This phase III study is assessing the drug's safety and is aiming to demonstrate efficacy of repeated intratympanic AM-101 injections in the treatment of acute peripheral tinnitus (up to 3 months (Stratum A), or between \>3 and 6 months (Stratum B) from onset).
Interventions
DRUGAM-101
AM-101 gel for intratympanic injection
DRUGPlacebo
Placebo gel for intratympanic injection
Sponsors
Auris Medical AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
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 (Stratum A) or between \>3 months and 6 months (Stratum B) prior to randomization, as documented by medical report or by documented medical history. Upon implementation of protocol amendment 6, subjects with tinnitus following traumatic cochlear injury will only be eligible if they are affected only unilaterally. 2. Age ≥ 18 years and ≤ 75 years; 3. Negative pregnancy test (woman of childbearing potential); 4. 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; 5. Willing and able to protect ear canal and middle ear from water exposure as long as tympanic membrane is not fully closed. Other protocol-defined inclusion criteria may apply.
Exclusion criteria
1. Fluctuating tinnitus; 2. Intermittent tinnitus; 3. Tinnitus resulting from traumatic head or neck injury; 4. Presence of chronic tinnitus; 5. Meniere's Disease, history of endolymphatic hydrops, or history of fluctuating hearing loss; 6. History of repeated idiopathic sudden sensorineural hearing loss or history of acoustic neuroma; 7. Ongoing acute or chronic otitis media or otitis externa; 8. Other treatment of tinnitus for the study duration; 9. Known hypersensitivity, allergy or intolerance to the study medication or any history of severe, abnormal drug reaction; 10. Women who are breast-feeding, pregnant or who are planning to become pregnant during the study; 11. Women of childbearing potential who are unwilling or unable to practice contraception, such as hormonal contraceptives, double barrier, sexual abstinence or intercourse with a partner who has been vasectomised for at least three months; 12. Concurrent participation in another clinical study or participation in another clinical study within 30 days prior to randomization. Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy endpoint - alternate primary efficacy endpoints: Tinnitus Functional Index (TFI) | Baseline to Day 84 | Improvement in TFI total score |
| Efficacy endpoint - alternate primary efficacy endpoints: Patient-reported Tinnitus loudness on a Numerical Rating Scale (TLQ NRS loudest) | Baseline to Day 84 | Improvement in TLQ NRS loudest |
| Safety endpoint: Hearing threshold | Baseline to Day 35 | Occurrence of deterioration in hearing threshold \>= 15 decibel (dB) at the average of two contiguous test frequencies (air conduction) in the treated ear(s) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy endpoint - TFI sleep score | Baseline to Day10, Day 35 and Day 84 | Improvement in TFI sleep score. The subscale sleep will be evaluated only for subjects with a TFI Sleep score greater than 0 at baseline. |
| Efficacy endpoint - Patient global impression of change in tinnitus severity (PGIC Tinnitus) | at Day10, Day 35 and Day 84 | Patient global impression of change in tinnitus severity |
| Efficacy endpoint - TFI | Baseline to Day 10 and Day 35 | Improvement in TFI total score |
| Safety endpoint - AEs and SAEs | Up to Day 84 | Occurence and severity of adverse events (AEs) and serious adverse Events (SAEs), differentiated by relatedness, and by treatment-emergence and procedure-emergence |
| Safety endpoint - Hearing threshold | Baseline to Day 1, Day 2, Day 10 and Day 84 | Occurrence of deterioration in hearing threshold \>= 15 dB at the average of two contiguous test frequencies in the treated ear(s) |
| Efficacy endpoint - TLQ NRS loudest | Baseline to Day 10 and Day 35 | Improvement in patient-reported tinnitus loudness |
| Efficacy endpoint - patient-reported tinnitus annoyance (TAQ NRS worst) | Baseline to Day10, Day 35 and Day 84 | Improvement in TAQ NRS worst |
Countries
Germany
Outcome results
None listed