Back to resultsEfficacy of SENS 401 in Subjects With Severe or Profound Sudden Sensorineural Hearing Loss (AUDIBLE-S)
Primary Purpose
Severe Sudden Sensorineural Hearing Loss
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SENS-401
Placebo Oral Tablet
SENS-401
Sponsored by
About this trial
This is an interventional treatment trial for Severe Sudden Sensorineural Hearing Loss
Eligibility Criteria
The main criteria for inclusion:
- Male or female aged at least 18 years old
- Patients with unilateral idiopathic sudden sensorineural hearing loss or unilateral/bilateral acute acoustic trauma leading to sudden sensorineural hearing loss.
- Patients with sudden hearing loss with onset within 96 hours prior to prior to first study drug intake.
- Patients under highly effective contraception
The main criteria for exclusion:
- Bilateral idiopathic hearing loss
- Fluctuating hearing loss
- History of asymmetric hearing (>20 dB difference between ears) to the best knowledge of the patient
- Severe hearing loss (>90 dB) associated with unilateral (ipsilateral) complete vestibular loss.
- History of Ménière's disease, autoimmune hearing loss, radiation-induced hearing loss, acoustic neuroma (schwannoma), otosclerosis, suspected perilymph fistula or membrane rupture, suspected retro-cochlear lesion, or barotrauma
- Previous SSNHL in the affected ear within the past 6 weeks
- Complete loss of peripheral vestibular function on the affected side
- Any drug-based therapy for inner ear hearing loss that is ongoing or was performed in the past 6 weeks (except oral corticosteroids)
- Any ongoing or planned concomitant medication for the treatment of tinnitus until 6 weeks after administration.
- Any therapy known as ototoxic (e.g. aminoglycosides, cisplatin, loop diuretics, quinine etc.) at the current time or in the past 6 months or planned in the coming 3 months.
- Acute or chronic otitis media or otitis externa terminated less than 7 days
- Prior ear surgery of any kind (except ventilating tubes), or cochlear implants
- Known history of, or concomitant severe hepatic, gastrointestinal, cardiovascular, respiratory, neurological (except vertigo or tinnitus), hematological, renal, dermatological or psychiatric disease or substance abuse
- Neurological disorders including stroke, demyelinating disease, brain stem or cerebellar dysfunction within the last 3 months.
- Treatment with any investigational agent within 4 weeks or any past treatment with azasetron or with 5-HT3 antagonists, or any prior or planned treatment by antidepressant treatment containing serotoninergic agents.
- Patients with either a history of significant arrhythmia, or a history of conditions known to increase the proarrhythmic risk (e.g., congestive heart failure, long QT Syndrome, hypokalemia etc...).
Sites / Locations
- Multiprofile Hospital for Active Treatment Burgas AD Department of Otorhynolaryngology
- MI Minisrty of Interior Affair Sofia Clinic of Otorhinolaryngology
- Military Medical Academy; Clinic of Otorhynolaryngology
- CHU de Quebec - Centre Hospitalier de l'Universite Laval
- Wall Street ENT Clinic
- Fakultni nemocnice u sv. Anny v Brne-Klinika otorinolaryngologie a chirurgie hlavy a krku
- Fakultni nemocnice Hradec Kralove -Klinika otorinolaryngologie a chirurgie hlavy a krku
- Hôpital d'Instruction des Armées Percy
- Hôpital Européen
- Hôpital Lariboisière
- 109ème Antenne Médicale de Saint-Maixent l'école
- 43ème Antenne Médicale de Sarrebourg
- Hôpital d'Instruction des armées SAINTE ANNE
- Hôpital Pierre Paul Riquet- CHU Purpan
- Universitätsklinikum Tübingen Klinik für Hals-, Nasen- u. Ohrenheilkunde Plastische Operationen
- Hillel Yaffe Medical Center
- Rambam Medical Center Health Care Campus
- Lady Davis Carmel Medical Center
- Rabin Medical Center, Otolaryngology, Head and Neck Surgery Gour Shasha Tower Building, floor#7
- Clinical Hospital Center Dr Dragisa Misovic-Dedinje
- Clinical Center of Vojvodina
- MUDr. Igor Kažmér, s.r.o.
- Fakultna nemocnica s poliklinikou J. A. Reimana Presov, Oddelenie otorinolaryngologie a chirurgie hlavy a krku
- Istanbul Medeniyet University Goztepe Training and Research Hospital, Department of Ear,Nose,Throat
- Erciyes University Medical Faculty Department of Ear Nose Throat
- The Royal Hallamshire Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
29 mg dose group
43.5 mg dose group
placebo oral tablet
Arm Description
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.
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.
Patients will receive the study drug (placebo) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization.
Outcomes
Primary Outcome Measures
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).
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.
Secondary Outcome Measures
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).
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.
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).
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.
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).
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.
Change in Speech Discrimination Threshold From Baseline to 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.
Change in Speech Discrimination Threshold From Baseline to Day 84
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03603314
Brief Title
Efficacy of SENS 401 in Subjects With Severe or Profound Sudden Sensorineural Hearing Loss
Acronym
AUDIBLE-S
Official Title
A Two-part, Randomized, Double-blind, Placebo-controlled, Parallel-group, Efficacy and Safety Study of SENS-401 in Subjects With Severe or Profound Sudden Sensorineural Hearing Loss
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
February 15, 2019 (Actual)
Primary Completion Date
November 4, 2021 (Actual)
Study Completion Date
January 12, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sensorion
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Primary objective of the study is to assess the efficacy of SENS-401 on hearing loss in comparison to placebo at the end of the 4-week treatment period
Detailed Description
Patients will receive the study drug (SENS-401 or placebo) in the form of tablets by mouth, twice a day (3 tablets in the morning and 3 tablets in the evening), during the first 4 weeks after randomization.
SENS-401 is an investigational medicinal product. It belongs to a family of drugs known as "5 HT3 antagonist".
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Sudden Sensorineural Hearing Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
115 (Actual)
8. Arms, Groups, and Interventions
Arm Title
29 mg dose group
Arm Type
Experimental
Arm Description
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.
Arm Title
43.5 mg dose group
Arm Type
Experimental
Arm Description
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.
Arm Title
placebo oral tablet
Arm Type
Placebo Comparator
Arm Description
Patients will receive the study drug (placebo) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization.
Intervention Type
Drug
Intervention Name(s)
SENS-401
Intervention Description
29 mg dose group: tablets of 14.5 mg, oral route, by mouth, twice a day, during 4 weeks
Intervention Type
Other
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
placebo, oral route, by mouth, twice a day, during 4 weeks
Intervention Type
Drug
Intervention Name(s)
SENS-401
Intervention Description
43.5 mg dose groupe: tablets of 14.5 mg, oral route, by mouth, twice a day, during 4 weeks
Primary Outcome Measure Information:
Title
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).
Description
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.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
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).
Description
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.
Time Frame
Day 28
Title
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).
Description
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.
Time Frame
Day 28
Title
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).
Description
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.
Time Frame
Day 84
Title
Change in Speech Discrimination Threshold From Baseline to Day 28
Description
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.
Time Frame
Day 28
Title
Change in Speech Discrimination Threshold From Baseline to Day 84
Description
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.
Time Frame
Day 84
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
The main criteria for inclusion:
Male or female aged at least 18 years old
Patients with unilateral idiopathic sudden sensorineural hearing loss or unilateral/bilateral acute acoustic trauma leading to sudden sensorineural hearing loss.
Patients with sudden hearing loss with onset within 96 hours prior to prior to first study drug intake.
Patients under highly effective contraception
The main criteria for exclusion:
Bilateral idiopathic hearing loss
Fluctuating hearing loss
History of asymmetric hearing (>20 dB difference between ears) to the best knowledge of the patient
Severe hearing loss (>90 dB) associated with unilateral (ipsilateral) complete vestibular loss.
History of Ménière's disease, autoimmune hearing loss, radiation-induced hearing loss, acoustic neuroma (schwannoma), otosclerosis, suspected perilymph fistula or membrane rupture, suspected retro-cochlear lesion, or barotrauma
Previous SSNHL in the affected ear within the past 6 weeks
Complete loss of peripheral vestibular function on the affected side
Any drug-based therapy for inner ear hearing loss that is ongoing or was performed in the past 6 weeks (except oral corticosteroids)
Any ongoing or planned concomitant medication for the treatment of tinnitus until 6 weeks after administration.
Any therapy known as ototoxic (e.g. aminoglycosides, cisplatin, loop diuretics, quinine etc.) at the current time or in the past 6 months or planned in the coming 3 months.
Acute or chronic otitis media or otitis externa terminated less than 7 days
Prior ear surgery of any kind (except ventilating tubes), or cochlear implants
Known history of, or concomitant severe hepatic, gastrointestinal, cardiovascular, respiratory, neurological (except vertigo or tinnitus), hematological, renal, dermatological or psychiatric disease or substance abuse
Neurological disorders including stroke, demyelinating disease, brain stem or cerebellar dysfunction within the last 3 months.
Treatment with any investigational agent within 4 weeks or any past treatment with azasetron or with 5-HT3 antagonists, or any prior or planned treatment by antidepressant treatment containing serotoninergic agents.
Patients with either a history of significant arrhythmia, or a history of conditions known to increase the proarrhythmic risk (e.g., congestive heart failure, long QT Syndrome, hypokalemia etc...).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Géraldine HONNET, MD
Organizational Affiliation
Sensorion
Official's Role
Study Director
Facility Information:
Facility Name
Multiprofile Hospital for Active Treatment Burgas AD Department of Otorhynolaryngology
City
Burgas
ZIP/Postal Code
8000
Country
Bulgaria
Facility Name
MI Minisrty of Interior Affair Sofia Clinic of Otorhinolaryngology
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Military Medical Academy; Clinic of Otorhynolaryngology
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
CHU de Quebec - Centre Hospitalier de l'Universite Laval
City
Québec
ZIP/Postal Code
G1V 4G2
Country
Canada
Facility Name
Wall Street ENT Clinic
City
Saskatoon
ZIP/Postal Code
S7K 1N4
Country
Canada
Facility Name
Fakultni nemocnice u sv. Anny v Brne-Klinika otorinolaryngologie a chirurgie hlavy a krku
City
Brno
Country
Czechia
Facility Name
Fakultni nemocnice Hradec Kralove -Klinika otorinolaryngologie a chirurgie hlavy a krku
City
Hradec Králové
Country
Czechia
Facility Name
Hôpital d'Instruction des Armées Percy
City
Clamart
ZIP/Postal Code
92140
Country
France
Facility Name
Hôpital Européen
City
Marseille
ZIP/Postal Code
13003
Country
France
Facility Name
Hôpital Lariboisière
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
109ème Antenne Médicale de Saint-Maixent l'école
City
Saint-Maixent-l'École
ZIP/Postal Code
79400
Country
France
Facility Name
43ème Antenne Médicale de Sarrebourg
City
Sarrebourg
ZIP/Postal Code
57404
Country
France
Facility Name
Hôpital d'Instruction des armées SAINTE ANNE
City
Toulon
ZIP/Postal Code
83000
Country
France
Facility Name
Hôpital Pierre Paul Riquet- CHU Purpan
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Universitätsklinikum Tübingen Klinik für Hals-, Nasen- u. Ohrenheilkunde Plastische Operationen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Name
Rambam Medical Center Health Care Campus
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Lady Davis Carmel Medical Center
City
Haifa
ZIP/Postal Code
3436212
Country
Israel
Facility Name
Rabin Medical Center, Otolaryngology, Head and Neck Surgery Gour Shasha Tower Building, floor#7
City
Petah tikva
ZIP/Postal Code
4341492
Country
Israel
Facility Name
Clinical Hospital Center Dr Dragisa Misovic-Dedinje
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Center of Vojvodina
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
Facility Name
MUDr. Igor Kažmér, s.r.o.
City
Liptovský Mikuláš
ZIP/Postal Code
03101
Country
Slovakia
Facility Name
Fakultna nemocnica s poliklinikou J. A. Reimana Presov, Oddelenie otorinolaryngologie a chirurgie hlavy a krku
City
Prešov
ZIP/Postal Code
08001
Country
Slovakia
Facility Name
Istanbul Medeniyet University Goztepe Training and Research Hospital, Department of Ear,Nose,Throat
City
Istanbul
ZIP/Postal Code
34722
Country
Turkey
Facility Name
Erciyes University Medical Faculty Department of Ear Nose Throat
City
Melikgazi
ZIP/Postal Code
38039
Country
Turkey
Facility Name
The Royal Hallamshire Hospital
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Efficacy of SENS 401 in Subjects With Severe or Profound Sudden Sensorineural Hearing Loss
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