Overview

This trial is active, not recruiting.

Condition tinnitus
Treatments am-101, placebo
Phase phase 3
Sponsor Auris Medical AG
Start date January 2014
End date September 2016
Trial size 653 participants
Trial identifier NCT02040194, AM-101-CL-12-02

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
AM-101
am-101
AM-101 gel for intratympanic injection
(Placebo Comparator)
Placebo
placebo
Placebo gel for intratympanic injection

Primary Outcomes

Measure
Tinnitus loudness
time frame: Day 84
Hearing threshold
time frame: Day 35

Secondary Outcomes

Measure
Responders
time frame: Day 84
Tinnitus questionnaires
time frame: Up to Day 84
Tinnitus loudness
time frame: Up to Day 35
Hearing threshold
time frame: Up to Day 84
Adverse events and serious adverse events
time frame: Up to Day 84

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: 1. Persistent subjective peripheral tinnitus 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; 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.

Additional Information

Official title Efficacy and Safety of AM-101 in the Treatment of Acute Peripheral Tinnitus 3
Description This phase III study is assessing the drug's safety and is aiming to demonstrate efficacy of repeated intratymanic 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).
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Auris Medical, Inc..