Back to resultsAM-101 in the Treatment of Acute Tinnitus 2 (TACTT2)
Primary Purpose
Tinnitus
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
AM-101
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Tinnitus
Eligibility Criteria
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.
Sites / Locations
- Medpace
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
AM-101 injection
Placebo injection
Arm Description
AM-101
Placebo
Outcomes
Primary Outcome Measures
Efficacy: Change in Patient-reported Tinnitus Loudness Questionnaire (TLQ) Improvement From Baseline to Follow up Visit 3 (FUV3)
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.
Co-Primary Efficacy: Improvement in Tinnitus Functional Index (TFI) Total Score From Baseline to 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
Safety: Frequency of Subjects With Deterioration of Hearing at Follow up Visit 2 (FUV2)
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01803646
Brief Title
AM-101 in the Treatment of Acute Tinnitus 2
Acronym
TACTT2
Official Title
Efficacy and Safety of AM-101 in the Treatment of Acute Peripheral Tinnitus 2
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Auris Medical, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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 onset).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
343 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AM-101 injection
Arm Type
Experimental
Arm Description
AM-101
Arm Title
Placebo injection
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
AM-101
Intervention Description
AM-101 gel for intratympanic injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo gel for intratympanic injection
Primary Outcome Measure Information:
Title
Efficacy: Change in Patient-reported Tinnitus Loudness Questionnaire (TLQ) Improvement From Baseline to Follow up Visit 3 (FUV3)
Description
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.
Time Frame
Screening (D-14) versus final follow-up (D83)
Title
Co-Primary Efficacy: Improvement in Tinnitus Functional Index (TFI) Total Score From Baseline to FUV3
Description
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
Time Frame
D0 (=TV1) versus Day 84 (=FUV3)
Title
Safety: Frequency of Subjects With Deterioration of Hearing at Follow up Visit 2 (FUV2)
Description
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.
Time Frame
Day 35
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Medpace
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28608739
Citation
Staecker H, Morelock M, Kramer T, Chrbolka P, Ahn JH, Meyer T. Safety of Repeated-Dose Intratympanic Injections with AM-101 in Acute Inner Ear Tinnitus. Otolaryngol Head Neck Surg. 2017 Sep;157(3):478-487. doi: 10.1177/0194599817711378. Epub 2017 Jun 13.
Results Reference
result
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AM-101 in the Treatment of Acute Tinnitus 2
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