Status:
COMPLETED
AM-101 in the Treatment of Acute Tinnitus 2
Lead Sponsor:
Auris Medical, Inc.
Conditions:
Tinnitus
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 inne...
Detailed 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 from ...
Eligibility Criteria
Inclusion
- 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 prior to randomization
- Age ≥ 18 years and ≤ 75 years (≥ 14 years and ≤ 75 years at selected sites);
- Negative pregnancy test (woman of childbearing potential);
- 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;
- 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
- Fluctuating tinnitus;
- Intermittent tinnitus;
- Tinnitus resulting from traumatic head or neck injury;
- Presence of chronic tinnitus;
- Meniere's Disease, history of endolymphatic hydrops, or history of fluctuating hearing loss;
- History of repeated idiopathic sudden sensorineural hearing loss or history of acoustic neuroma;
- Ongoing acute or chronic otitis media or otitis externa;
- Other treatment of tinnitus for the study duration;
- Known hypersensitivity, allergy or intolerance to the study medication or any history of severe, abnormal drug reaction;
- Women who are breast-feeding, pregnant or who are planning to become pregnant during the study;
- 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;
- 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.
Key Trial Info
Start Date :
February 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
343 Patients enrolled
Trial Details
Trial ID
NCT01803646
Start Date
February 1 2014
End Date
June 1 2016
Last Update
May 29 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Medpace
Cincinnati, Ohio, United States, 45227