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Completed

NCT Number: NCT01803646

AM-101 in the Treatment of Acute Tinnitus 2

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.

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Key information

Conditions

Tinnitus Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medpace

Cincinnati, Ohio, 45227, United States

About this study

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 onset).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

AM-101

Drug

AM-101 gel for intratympanic injection

Placebo

Drug

Placebo gel for intratympanic injection

Primary outcomes

  1. 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 describes your tinnitus at its loudest in the last 24 hours (including right now)?" TLQ NRSLoudest was collected from SV (D-14) to the evening before FUV3 (D83). The ratings were to be recorded every day before going to sleep on an electronic device.

    As Baseline the10 ratings of the screening period before the first treatment were averaged. For the FUV3 endpoint, the ratings of the 7 days before FUV3 were averaged.

  2. 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 question is to be rated on a NRS between 0 and 10 (or 0 to 100%), with a recall period of "over the past week".

    The TFI total score is considered as valid if there are evaluable answers for at least 19 of the 25 items (76% of items) (Meikle et al. 2012). The repondent's overall TFI score is within a 0-100 range. For the subscales the range is the same. A lower value represents an improvement for all scales.

    Please refer to the following publicly available link for more information: http://download.lww.com/wolterskluwer_vitalstream_com/PermaLink/EANDH/A/EANDH_2011_09_27_HENRY_200593_SDC15.pdf

  3. 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.

Sponsors and collaborators

Lead sponsor

Auris Medical, Inc.

Industry

Registry information

Official study title

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

Acronym: TACTT2

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 4, 2013
Registry last updated
May 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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