NCT01803646: TACTT2

Efficacy and Safety of AM-101 in the Treatment of Acute Peripheral Tinnitus 2

Completed Phase 3 Results posted Last updated 25 May 2018

What this trial tests

Phase 3 trial testing AM-101 in Tinnitus in 343 participants. Completed in 1 June 2016.

Timeline

1 February 2014

Primary endpoint
1 June 2016

1 June 2016

Quick facts

Lead sponsor	Auris Medical, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	343
Start date	1 February 2014
Primary completion	1 June 2016
Estimated completion	1 June 2016
Sites	1 location across United States

Drugs / interventions tested

• AM-101 — full drug profile →
• Placebo

Conditions studied

• Tinnitus — all drugs for Tinnitus →

Sponsor

Auris Medical, Inc. — full company profile →

Who can join

Adults 18 to 75, any sex, with Tinnitus. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Efficacy: Change in Patient-reported Tinnitus Loudness Questionnaire (TLQ) Improvement From Baseline to Follow up Visit 3 (FUV3)
  Time frame: Screening (D-14) versus final follow-up (D83)
  Starting at the screening visit (SV), each subject recorded the following numerical rating scales (NRS) throughout the entire study duration: \- Tinnitus loudness "at its loudest" within the last 24 hours (Tinnitus Loudness Questionnaire \[TLQ\] NRSLoudest). Subjects were asked "On a scale from 0 to 10, where 0 represents no tinnitus and 10 represents extremely loud tinnitus, what one number best
• Co-Primary Efficacy: Improvement in Tinnitus Functional Index (TFI) Total Score From Baseline to FUV3
  Time frame: D0 (=TV1) versus Day 84 (=FUV3)
  The TFI was recorded on an electronic device (electronic patient reported outcome) at Treatment Visit 1 (TV1), before randomization, and at Follow up Visit 1 (FUV1), FUV2 and FUV3. The TFI is a patient reported outcome questionnaire and contains 25 questions. It includes eight subscales: Intrusive, Sense of Control, Cognitive, Sleep, Auditory, Relaxation, Quality of Life, and Emotional. Each ques
• Safety: Frequency of Subjects With Deterioration of Hearing at Follow up Visit 2 (FUV2)
  Time frame: Day 35
  Occurence of deterioration of hearing (Air and Bone conduction) in the treated ear at FUV2. Deterioration is defined as a deterioration of hearing threshold of at least 15 dB from Baseline at the average of 2 contiguous frequencies.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. What's the buzz? The neuroscience and the treatment of tinnitus.
   Henton A, Tzounopoulos T. · · 2021 · cited 85× · PMID 33769102 · DOI 10.1152/physrev.00029.2020