Trial Outcomes & Findings for Efficacy of SENS 401 in Subjects With Severe or Profound Sudden Sensorineural Hearing Loss (NCT NCT03603314)

Last Updated: 2023-03-01

Results Overview

Pure Tone Audiometry PTA (dB) thresholds were determined for each ear at 0.25, 0.5, 1, 2, 3, 4, 6, and 8 kHz for air conduction and 0.5, 1, 2, 3, 4 kHz for bone conduction. Pure Tone Audiometry PTA (dB) is an hearing test used to identify hearing threshold levels of an individual and enabling determination of the degree hearing loss. A clinically significative improvement is defined as a decrease of at least 10 dB of hearing threshold.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

115 participants

Primary outcome timeframe

28 days

Results posted on

2023-03-01

Participant Flow

Participant milestones

Participant milestones
Measure	29 mg Dose Group Patients will receive the study drug (SENS-401) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization. SENS-401: 29 mg dose group: tablets of 14.5 mg, oral route, by mouth, twice a day, during 4 weeks	43.5 mg Dose Group Patients will receive the study drug (SENS-401) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization. SENS-401: 43.5 mg dose groupe: tablets of 14.5 mg, oral route, by mouth, twice a day, during 4 weeks	Placebo Oral Tablet Patients will receive the study drug (placebo) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization. Placebo Oral Tablet: placebo, oral route, by mouth, twice a day, during 4 weeks
Overall Study STARTED	38	39	38
Overall Study COMPLETED	31	28	35
Overall Study NOT COMPLETED	7	11	3

Reasons for withdrawal

Reasons for withdrawal
Measure	29 mg Dose Group Patients will receive the study drug (SENS-401) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization. SENS-401: 29 mg dose group: tablets of 14.5 mg, oral route, by mouth, twice a day, during 4 weeks	43.5 mg Dose Group Patients will receive the study drug (SENS-401) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization. SENS-401: 43.5 mg dose groupe: tablets of 14.5 mg, oral route, by mouth, twice a day, during 4 weeks	Placebo Oral Tablet Patients will receive the study drug (placebo) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization. Placebo Oral Tablet: placebo, oral route, by mouth, twice a day, during 4 weeks
Overall Study Lost to Follow-up	0	3	0
Overall Study Protocol Violation	0	1	0
Overall Study Adverse Event	2	0	0
Overall Study Physician Decision	1	1	0
Overall Study Withdrawal by Subject	4	5	3
Overall Study Other	0	1	0

Baseline Characteristics

Efficacy of SENS 401 in Subjects With Severe or Profound Sudden Sensorineural Hearing Loss

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	29 mg Dose Group n=38 Participants Patients will receive the study drug (SENS-401) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization. SENS-401: 29 mg dose group: tablets of 14.5 mg, oral route, by mouth, twice a day, during 4 weeks	43.5 mg Dose Group n=39 Participants Patients will receive the study drug (SENS-401) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization. SENS-401: 43.5 mg dose groupe: tablets of 14.5 mg, oral route, by mouth, twice a day, during 4 weeks	Placebo Oral Tablet n=38 Participants Patients will receive the study drug (placebo) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization. Placebo Oral Tablet: placebo, oral route, by mouth, twice a day, during 4 weeks	Total n=115 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=5 Participants	36 Participants n=7 Participants	34 Participants n=5 Participants	98 Participants n=4 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	17 Participants n=4 Participants
Age, Continuous	56.0 years STANDARD_DEVIATION 16.40 • n=5 Participants	46.9 years STANDARD_DEVIATION 16.01 • n=7 Participants	49.8 years STANDARD_DEVIATION 14.56 • n=5 Participants	50.3 years STANDARD_DEVIATION 15.86 • n=4 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	17 Participants n=7 Participants	9 Participants n=5 Participants	40 Participants n=4 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	22 Participants n=7 Participants	29 Participants n=5 Participants	75 Participants n=4 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic or Latino	2 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	9 Participants n=4 Participants
Race/Ethnicity, Customized Ethnicity · Not Hispanic or Latino	36 Participants n=5 Participants	34 Participants n=7 Participants	36 Participants n=5 Participants	106 Participants n=4 Participants
Race/Ethnicity, Customized Ethnicity · White	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants	NA Participants n=4 Participants
Race/Ethnicity, Customized Ethnicity · Unknown	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants	NA Participants n=4 Participants
Race/Ethnicity, Customized Race · Hispanic or Latino	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants	NA Participants n=4 Participants
Race/Ethnicity, Customized Race · Not Hispanic or Latino	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants	NA Participants n=4 Participants
Race/Ethnicity, Customized Race · White	33 Participants n=5 Participants	31 Participants n=7 Participants	36 Participants n=5 Participants	100 Participants n=4 Participants
Race/Ethnicity, Customized Race · Unknown	5 Participants n=5 Participants	8 Participants n=7 Participants	2 Participants n=5 Participants	15 Participants n=4 Participants

PRIMARY outcome

Timeframe: 28 days

Outcome measures

Outcome measures
Measure	29 mg Dose Group n=38 Participants Patients will receive the study drug (SENS-401) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization. SENS-401: 29 mg dose group: tablets of 14.5 mg, oral route, by mouth, twice a day, during 4 weeks	43.5 mg Dose Group n=39 Participants Patients will receive the study drug (SENS-401) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization. SENS-401: 43.5 mg dose groupe: tablets of 14.5 mg, oral route, by mouth, twice a day, during 4 weeks	Placebo Oral Tablet n=38 Participants Patients will receive the study drug (placebo) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization. Placebo Oral Tablet: placebo, oral route, by mouth, twice a day, during 4 weeks
Change in Pure Tone Audiometry PTA (dB) (Average of the Hearing Threshold of the 3 Contiguous Most Affected Hearing Frequencies in dB as Identified at Study Entry) From Baseline to the End of Treatment Visit (Day 28 ± 3).	-27.754 dB Interval -40.534 to -14.974	-24.931 dB Interval -37.793 to -12.069	-25.214 dB Interval -38.31 to -12.119

SECONDARY outcome

Timeframe: Day 28

Outcome measures

Outcome measures
Measure	29 mg Dose Group n=38 Participants Patients will receive the study drug (SENS-401) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization. SENS-401: 29 mg dose group: tablets of 14.5 mg, oral route, by mouth, twice a day, during 4 weeks	43.5 mg Dose Group n=39 Participants Patients will receive the study drug (SENS-401) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization. SENS-401: 43.5 mg dose groupe: tablets of 14.5 mg, oral route, by mouth, twice a day, during 4 weeks	Placebo Oral Tablet n=38 Participants Patients will receive the study drug (placebo) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization. Placebo Oral Tablet: placebo, oral route, by mouth, twice a day, during 4 weeks
Change in Pure Tone Audiometry PTA (dB) (Average of the Hearing Threshold of the 2 Most Affected Hearing Frequencies in dB as Identified at Study Entry) From Baseline to the End of Treatment Visit (Day 28 ± 3).	-27.910 dB Interval -41.211 to -14.61	-24.468 dB Interval -37.86 to -11.076	-25.726 dB Interval -39.369 to -12.084

SECONDARY outcome

Timeframe: Day 28

Outcome measures

Outcome measures
Measure	29 mg Dose Group n=38 Participants Patients will receive the study drug (SENS-401) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization. SENS-401: 29 mg dose group: tablets of 14.5 mg, oral route, by mouth, twice a day, during 4 weeks	43.5 mg Dose Group n=39 Participants Patients will receive the study drug (SENS-401) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization. SENS-401: 43.5 mg dose groupe: tablets of 14.5 mg, oral route, by mouth, twice a day, during 4 weeks	Placebo Oral Tablet n=38 Participants Patients will receive the study drug (placebo) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization. Placebo Oral Tablet: placebo, oral route, by mouth, twice a day, during 4 weeks
Change in Pure Tone Audiometry PTA (dB) (the Most Affected Hearing Frequencies in dB as Identified at Study Entry) From Baseline to the End of Treatment Visit (Day 28 ± 3).	-30.889 dB Interval -44.619 to -17.159	-30.035 dB Interval -43.85 to -16.22	-29.371 dB Interval -43.469 to -15.272

SECONDARY outcome

Timeframe: Day 84

Outcome measures

Outcome measures
Measure	29 mg Dose Group n=33 Participants Patients will receive the study drug (SENS-401) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization. SENS-401: 29 mg dose group: tablets of 14.5 mg, oral route, by mouth, twice a day, during 4 weeks	43.5 mg Dose Group n=30 Participants Patients will receive the study drug (SENS-401) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization. SENS-401: 43.5 mg dose groupe: tablets of 14.5 mg, oral route, by mouth, twice a day, during 4 weeks	Placebo Oral Tablet n=33 Participants Patients will receive the study drug (placebo) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization. Placebo Oral Tablet: placebo, oral route, by mouth, twice a day, during 4 weeks
Change in Pure Tone Audiometry PTA (dB) (Average of the Hearing Threshold of the 3 Most Affected Hearing Frequencies in dB as Identified at Study Entry) From Baseline to the End of Study Visit (Day 84 ± 3).	-32.469 dB Interval -45.229 to -19.708	-30.070 dB Interval -42.881 to -17.259	-25.399 dB Interval -38.363 to -12.435

SECONDARY outcome

Timeframe: Day 28

The Speech recognition threshold (SRT) (dB) is the minimum hearing level at which an individual can correctly recognize 50% of speech material; the more severe the hearing loss is, the higher SRT is. Spondaic words are the usual and recommended test material for the speech recognition threshold; spondaic words are two-syllable words with equal stress on both syllables (eg, birthday). Per the American Speech-Language-Hearing Association (ASHA) guidelines, subjects were familiarized with the spondaic words prior to the test; they listened to the list of words and indicated if any were unfamiliar. These words could then be eliminated from the list.

Outcome measures

Outcome measures
Measure	29 mg Dose Group n=38 Participants Patients will receive the study drug (SENS-401) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization. SENS-401: 29 mg dose group: tablets of 14.5 mg, oral route, by mouth, twice a day, during 4 weeks	43.5 mg Dose Group n=39 Participants Patients will receive the study drug (SENS-401) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization. SENS-401: 43.5 mg dose groupe: tablets of 14.5 mg, oral route, by mouth, twice a day, during 4 weeks	Placebo Oral Tablet n=38 Participants Patients will receive the study drug (placebo) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization. Placebo Oral Tablet: placebo, oral route, by mouth, twice a day, during 4 weeks
Change in Speech Discrimination Threshold From Baseline to Day 28	-22.899 dB Interval -35.836 to -9.962	-19.882 dB Interval -33.015 to -6.748	-19.827 dB Interval -33.336 to -6.318

SECONDARY outcome

Timeframe: Day 84

Outcome measures

Outcome measures
Measure	29 mg Dose Group n=33 Participants Patients will receive the study drug (SENS-401) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization. SENS-401: 29 mg dose group: tablets of 14.5 mg, oral route, by mouth, twice a day, during 4 weeks	43.5 mg Dose Group n=30 Participants Patients will receive the study drug (SENS-401) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization. SENS-401: 43.5 mg dose groupe: tablets of 14.5 mg, oral route, by mouth, twice a day, during 4 weeks	Placebo Oral Tablet n=33 Participants Patients will receive the study drug (placebo) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization. Placebo Oral Tablet: placebo, oral route, by mouth, twice a day, during 4 weeks
Change in Speech Discrimination Threshold From Baseline to Day 84	-24.990 dB Interval -38.04 to -11.94	-22.671 dB Interval -35.939 to -9.403	-16.642 dB Interval -30.236 to -3.048

Adverse Events

29 mg Dose Group

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

43.5 mg Dose Group

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Placebo Oral Tablet

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	29 mg Dose Group n=38 participants at risk Patients will receive the study drug (SENS-401) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization. SENS-401: 29 mg dose group: tablets of 14.5 mg, oral route, by mouth, twice a day, during 4 weeks	43.5 mg Dose Group n=39 participants at risk Patients will receive the study drug (SENS-401) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization. SENS-401: 43.5 mg dose groupe: tablets of 14.5 mg, oral route, by mouth, twice a day, during 4 weeks	Placebo Oral Tablet n=38 participants at risk Patients will receive the study drug (placebo) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization. Placebo Oral Tablet: placebo, oral route, by mouth, twice a day, during 4 weeks
Nervous system disorders diziness	0.00% 0/38 • 84 days	0.00% 0/39 • 84 days	2.6% 1/38 • Number of events 1 • 84 days
General disorders fatigue	2.6% 1/38 • Number of events 1 • 84 days	0.00% 0/39 • 84 days	0.00% 0/38 • 84 days
Nervous system disorders headache	2.6% 1/38 • Number of events 1 • 84 days	0.00% 0/39 • 84 days	0.00% 0/38 • 84 days
Neoplasms benign, malignant and unspecified (incl cysts and polyps) colon neoplasm	0.00% 0/38 • 84 days	2.6% 1/39 • Number of events 1 • 84 days	0.00% 0/38 • 84 days

Other adverse events

Other adverse events
Measure	29 mg Dose Group n=38 participants at risk Patients will receive the study drug (SENS-401) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization. SENS-401: 29 mg dose group: tablets of 14.5 mg, oral route, by mouth, twice a day, during 4 weeks	43.5 mg Dose Group n=39 participants at risk Patients will receive the study drug (SENS-401) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization. SENS-401: 43.5 mg dose groupe: tablets of 14.5 mg, oral route, by mouth, twice a day, during 4 weeks	Placebo Oral Tablet n=38 participants at risk Patients will receive the study drug (placebo) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization. Placebo Oral Tablet: placebo, oral route, by mouth, twice a day, during 4 weeks
Gastrointestinal disorders Constipation	26.3% 10/38 • Number of events 11 • 84 days	15.4% 6/39 • Number of events 7 • 84 days	2.6% 1/38 • Number of events 1 • 84 days
Gastrointestinal disorders Nausea	7.9% 3/38 • Number of events 3 • 84 days	5.1% 2/39 • Number of events 2 • 84 days	2.6% 1/38 • Number of events 1 • 84 days
Gastrointestinal disorders Vomiting	5.3% 2/38 • Number of events 2 • 84 days	2.6% 1/39 • Number of events 1 • 84 days	0.00% 0/38 • 84 days
Nervous system disorders Headache	15.8% 6/38 • Number of events 7 • 84 days	15.4% 6/39 • Number of events 6 • 84 days	0.00% 0/38 • 84 days
Nervous system disorders Dizziness	10.5% 4/38 • Number of events 6 • 84 days	0.00% 0/39 • 84 days	0.00% 0/38 • 84 days
Ear and labyrinth disorders Vertigo	5.3% 2/38 • Number of events 2 • 84 days	2.6% 1/39 • Number of events 1 • 84 days	5.3% 2/38 • Number of events 2 • 84 days
Vascular disorders Hypertension	10.5% 4/38 • Number of events 5 • 84 days	0.00% 0/39 • 84 days	2.6% 1/38 • Number of events 1 • 84 days
Psychiatric disorders Insomnia	5.3% 2/38 • Number of events 2 • 84 days	0.00% 0/39 • 84 days	0.00% 0/38 • 84 days
Musculoskeletal and connective tissue disorders Arthralgia	5.3% 2/38 • Number of events 2 • 84 days	0.00% 0/39 • 84 days	0.00% 0/38 • 84 days
Infections and infestations COVID-19	0.00% 0/38 • 84 days	5.1% 2/39 • Number of events 2 • 84 days	2.6% 1/38 • Number of events 1 • 84 days

Additional Information

Director of Regulatory Affairs

Sensorion

Phone: +33467207720

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place