AM-101 in the Treatment of Acute Tinnitus 3

Phase 3

Completed

• Conditions: Tinnitus
• Interventions: Drug: AM-101; Drug: Placebo

• Registration Number: NCT02040194
• Lead Sponsor: Auris Medical AG

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).

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-14
• Study First Submitted QC: 2014-01-17
• Study First Posted: 2014-01-20
• Primary Completion: 2017-12-28
• Study Completion: 2017-12-28
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-13
• Last Update Posted: 2023-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 893

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 exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AM-101 injection	AM-101	AM-101
Placebo injection	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
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)
Efficacy endpoint - alternate primary efficacy endpoints: Tinnitus Functional Index (TFI)	Baseline to Day 84	Improvement in TFI total score

Secondary Outcome Measures

Name	Time	Method
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
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
Efficacy endpoint - TLQ NRS loudest	Baseline to Day 10 and Day 35	Improvement in patient-reported tinnitus loudness
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-reported tinnitus annoyance (TAQ NRS worst)	Baseline to Day10, Day 35 and Day 84	Improvement in TAQ NRS worst
Safety endpoint - Hearing threshold	Baseline to Day 1, Day 2, Day 10 and Day 84	Difference in occurrence of deterioration in hearing threshold \>= 15 dB at the average of two contiguous test frequencies between the treated and untreated contralateral ear (subjects with unilaterally treated tinnitus only)

Trial Locations

Locations (1)

Please check the study webpage below for a study site list; 🇩🇪 Munich, Germany