Severe Sudden Sensorineural Hearing LossPhase 2/3AUDIBLE-SNCT03603314
Efficacy of SENS 401 in Subjects With Severe or Profound Sudden Sensorineural Hearing Loss
A Phase 2/3 study testing SENS-401 in people with Severe Sudden Sensorineural Hearing Loss, run by Sensorion at 26 sites in 10 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Sudden Sensorineural Hearing Loss
- What is being tested?
- SENS-401
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 115 participants
- Where
- 26 sitesin 10 countries
- Study dates
- 15 Feb 2019to 12 Jan 2022
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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...).
Trial locations and contacts
26 sites in 10 countries.
26 sites in 10 countries
France7 sites
Hôpital d'Instruction des Armées Percy
Clamart, 92140
Hôpital Européen
Marseille, 13003
Hôpital Lariboisière
Paris, 75475
109ème Antenne Médicale de Saint-Maixent l'école
Saint-Maixent-l'École, 79400
43ème Antenne Médicale de Sarrebourg
Sarrebourg, 57404
Hôpital d'Instruction des armées SAINTE ANNE
Toulon, 83000
Hôpital Pierre Paul Riquet- CHU Purpan
Toulouse, 31059
Israel4 sites
Hillel Yaffe Medical Center
Hadera, 38100
Rambam Medical Center Health Care Campus
Haifa, 3109601
Lady Davis Carmel Medical Center
Haifa, 3436212
Rabin Medical Center, Otolaryngology, Head and Neck Surgery Gour Shasha Tower Building, floor#7
Petah Tikva, 4341492
Bulgaria3 sites
Multiprofile Hospital for Active Treatment Burgas AD Department of Otorhynolaryngology
Burgas, 8000
MI Minisrty of Interior Affair Sofia Clinic of Otorhinolaryngology
Sofia, 1606
Military Medical Academy; Clinic of Otorhynolaryngology
Sofia, 1606
Canada2 sites
CHU de Quebec - Centre Hospitalier de l'Universite Laval
Québec, G1V 4G2
Wall Street ENT Clinic
Saskatoon, S7K 1N4
Czechia2 sites
Fakultni nemocnice u sv. Anny v Brne-Klinika otorinolaryngologie a chirurgie hlavy a krku
Brno
Fakultni nemocnice Hradec Kralove -Klinika otorinolaryngologie a chirurgie hlavy a krku
Hradec Králové
Serbia2 sites
Clinical Hospital Center Dr Dragisa Misovic-Dedinje
Belgrade, 11000
Clinical Center of Vojvodina
Novi Sad, 21000
Slovakia2 sites
MUDr. Igor Kažmér, s.r.o.
Liptovský Mikuláš, 03101
Fakultna nemocnica s poliklinikou J. A. Reimana Presov, Oddelenie otorinolaryngologie a chirurgie hlavy a krku
Prešov, 08001
Turkey (Türkiye)2 sites
Istanbul Medeniyet University Goztepe Training and Research Hospital, Department of Ear,Nose,Throat
Istanbul, 34722
Erciyes University Medical Faculty Department of Ear Nose Throat
Melikgazi, 38039
Germany1 site
Universitätsklinikum Tübingen Klinik für Hals-, Nasen- u. Ohrenheilkunde Plastische Operationen
Tübingen, 72076
About this study
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
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
Read the 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".
- Conditions
- Severe Sudden Sensorineural Hearing Loss
- Being tested
- SENS-401, Placebo Oral Tablet
- Medical subject headings
- Hearing Loss, Sudden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SENS-401Drug
29 mg dose group: tablets of 14.5 mg, oral route, by mouth, twice a day, during 4 weeks
Placebo Oral TabletOther
placebo, oral route, by mouth, twice a day, during 4 weeks
SENS-401Drug
43.5 mg dose groupe: tablets of 14.5 mg, oral route, by mouth, twice a day, during 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 29 mg dose group | Experimental | 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. Receives: Drug: SENS-401 |
| 43.5 mg dose group | Experimental | 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. Receives: Drug: SENS-401 |
| placebo oral tablet | Placebo comparator | Patients will receive the study drug (placebo) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization. Receives: Other: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Secondary outcomes (5)
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.
Measured: Day 28
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.
Measured: Day 28
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.
Measured: Day 84
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.
Measured: Day 28
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.
Measured: Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start15 Feb 2019
- Primary completion4 Nov 2021
- Study completion12 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Severe Sudden Sensorineural Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sensorion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Géraldine HONNET, MD, Study director, Sensorion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03603314
- Sponsor's protocol ID
- SENS 401-201
- Acronym
- AUDIBLE-S
- Status last verified
- Dec 2022
- First submitted
- 5 Jul 2018
- Last updated
- 1 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03603314
- Acronym / sponsor ID
- AUDIBLE-S / SENS 401-201
- Conditions
- Severe Sudden Sensorineural Hearing Loss
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- SensorionIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 4 Nov 2021 (actual)
- Study completion
- 12 Jan 2022 (actual)
- First posted
- 27 Jul 2018 (actual)
- Results
- Posted 1 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 29 mg dose group | Experimental | Drug: SENS-401Patients will receive the study drug (SENS-401) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization. |
| 43.5 mg dose group | Experimental | Drug: SENS-401Patients will receive the study drug (SENS-401) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization. |
| placebo oral tablet | Placebo comparator | Other: Placebo Oral TabletPatients will receive the study drug (placebo) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SENS-40129 mg dose group: tablets of 14.5 mg, oral route, by mouth, twice a day, during 4 weeks | Drug | 29 mg dose group |
| Placebo Oral Tabletplacebo, oral route, by mouth, twice a day, during 4 weeks | Other | placebo oral tablet |
| SENS-40143.5 mg dose groupe: tablets of 14.5 mg, oral route, by mouth, twice a day, during 4 weeks | Drug | 43.5 mg dose group |
Primary outcome
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).
Time frame: 28 days
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.
5 secondary outcomes
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).
Time frame: Day 28
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).
Time frame: Day 28
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).
Time frame: Day 84
Change in Speech Discrimination Threshold From Baseline to Day 28
Time frame: Day 28
Change in Speech Discrimination Threshold From Baseline to Day 84
Time frame: Day 84
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Severe Sudden Sensorineural Hearing Loss
Not yet recruitingPhase 1/2
Study on the Safety and Efficacy of Intratympanic Injection of Small Extracellular Vesicles Derived From Mesenchymal Stem Cells in Severe and Profound Sudden Sensorineural Hearing Loss
Sudden Hearing Loss, Extracellular Vesicles
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Géraldine HONNET, MD study director
Sensorion
26 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing SENS-401 in people with Severe Sudden Sensorineural Hearing Loss, run by Sensorion at 26 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in France, Israel, Bulgaria, Canada, Czechia and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.