Efficacy and Safety of AM-111 as Acute Sudden Sensorineural Hearing Loss Treatment (ASSENT)
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| ClinicalTrials.gov Identifier: NCT02809118 |
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Recruitment Status :
Terminated
(Availability of relevant new efficacy data from another study)
First Posted : June 22, 2016
Results First Posted : August 7, 2020
Last Update Posted : August 7, 2020
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Condition |
Hearing Loss, Idiopathic Sudden Sensorineural |
| Interventions |
Drug: AM-111 0.4 mg/ml Drug: AM-111 0.8 mg/ml Other: Placebo |
| Enrollment | 56 |
| Recruitment Details |
The study was prematurely discontinued while recruitment was still low (56 out of the planned 300 subjects). Recruitment started on 16 June 2016. On 28 November 2017, recruitment was stopped. This study was conducted in USA, Canada and South Korea. |
| Pre-assignment Details | In subjects assessed within the first 24 hours from Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL) onset, mean hearing threshold had to be confirmed by a second measure that was conducted, at the earliest, 24 hours after the onset of ISSNHL. |
| Arm/Group Title | Placebo | AM-111 0.4 mg/ml | AM-111 0.8 mg/ml |
|---|---|---|---|
 Arm/Group Description |
Placebo gel for intratympanic use Placebo: Placebo gel is administered with a single dose into the affected ear after topical anesthesia |
AM-111 gel for intratympanic use (0.4 mg/ml AM-111) AM-111 0.4 mg/ml: AM-111 0.4 mg/mL gel is administered with a single dose into the affected ear after topical anesthesia |
AM-111 gel for intratympanic use (0.8 mg/ml AM-111) AM-111 0.8 mg/ml: AM-111 0.8 mg/mL gel is administered with a single dose into the affected ear after topical anesthesia |
| Period Title: Overall Study | |||
| Started | 18 | 19 | 19 |
| Completed | 18 | 18 | 18 |
| Not Completed | 0 | 1 | 1 |
| Reason Not Completed | |||
| Withdrawal by Subject | 0 | 1 | 1 |
| Arm/Group Title | Placebo | AM-111 0.4 mg/ml | AM-111 0.8 mg/ml | Total | |
|---|---|---|---|---|---|
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Arm/Group Description |
Placebo gel for intratympanic use Placebo: Placebo gel is administered with a single dose into the affected ear after topical anesthesia |
AM-111 gel for intratympanic use (0.4 mg/ml AM-111) AM-111 0.4 mg/ml: AM-111 0.4 mg/mL gel is administered with a single dose into the affected ear after topical anesthesia |
AM-111 gel for intratympanic use (0.8 mg/ml AM-111) AM-111 0.8 mg/ml: AM-111 0.8 mg/mL gel is administered with a single dose into the affected ear after topical anesthesia |
Total of all reporting groups | |
| Overall Number of Baseline Participants | 18 | 19 | 19 | 56 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Customized
Mean (Standard Deviation) Unit of measure: Years |
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| Age | Number Analyzed | 18 participants | 19 participants | 19 participants | 56 participants |
| 57.7 (15.25) | 57.0 (15.13) | 54.6 (14.36) | 55.6 (14.96) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 18 participants | 19 participants | 19 participants | 56 participants | |
| Female |
12 66.7%
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7 36.8%
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8 42.1%
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27 48.2%
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| Male |
6 33.3%
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12 63.2%
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11 57.9%
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29 51.8%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 18 participants | 19 participants | 19 participants | 56 participants | |
| American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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| Asian |
12 66.7%
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8 42.1%
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11 57.9%
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31 55.4%
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| Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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| Black or African American |
0 0.0%
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1 5.3%
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1 5.3%
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2 3.6%
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| White |
6 33.3%
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10 52.6%
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6 31.6%
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22 39.3%
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| More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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| Unknown or Not Reported |
0 0.0%
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0 0.0%
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1 5.3%
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1 1.8%
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| Name/Title: | RAM |
| Organization: | Auris Medical |
| Phone: | 0041 61 201 13 ext 50 |
| EMail: | ra@aurismedical.com |
| Responsible Party: | Auris Medical, Inc. |
| ClinicalTrials.gov Identifier: | NCT02809118 |
| Other Study ID Numbers: |
AM-111-CL-15-01 |
| First Submitted: | June 20, 2016 |
| First Posted: | June 22, 2016 |
| Results First Submitted: | April 24, 2020 |
| Results First Posted: | August 7, 2020 |
| Last Update Posted: | August 7, 2020 |