Severe Sudden Sensorineural Hearing Loss Clinical Trial
— AUDIBLE-SOfficial 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
| Verified date | December 2022 |
| Source | Sensorion |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 115 |
| Est. completion date | January 12, 2022 |
| Est. primary completion date | November 4, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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...). |
| Country | Name | City | State |
|---|---|---|---|
| Bulgaria | Multiprofile Hospital for Active Treatment Burgas AD Department of Otorhynolaryngology | Burgas | |
| Bulgaria | MI Minisrty of Interior Affair Sofia Clinic of Otorhinolaryngology | Sofia | |
| Bulgaria | Military Medical Academy; Clinic of Otorhynolaryngology | Sofia | |
| Canada | CHU de Quebec - Centre Hospitalier de l'Universite Laval | Québec | |
| Canada | Wall Street ENT Clinic | Saskatoon | |
| Czechia | Fakultni nemocnice u sv. Anny v Brne-Klinika otorinolaryngologie a chirurgie hlavy a krku | Brno | |
| Czechia | Fakultni nemocnice Hradec Kralove -Klinika otorinolaryngologie a chirurgie hlavy a krku | Hradec Králové | |
| France | Hôpital d'Instruction des Armées Percy | Clamart | |
| France | Hôpital Européen | Marseille | |
| France | Hôpital Lariboisière | Paris | |
| France | 109ème Antenne Médicale de Saint-Maixent l'école | Saint-Maixent-l'École | |
| France | 43ème Antenne Médicale de Sarrebourg | Sarrebourg | |
| France | Hôpital d'Instruction des armées SAINTE ANNE | Toulon | |
| France | Hôpital Pierre Paul Riquet- CHU Purpan | Toulouse | |
| Germany | Universitätsklinikum Tübingen Klinik für Hals-, Nasen- u. Ohrenheilkunde Plastische Operationen | Tübingen | |
| Israel | Hillel Yaffe Medical Center | Hadera | |
| Israel | Lady Davis Carmel Medical Center | Haifa | |
| Israel | Rambam Medical Center Health Care Campus | Haifa | |
| Israel | Rabin Medical Center, Otolaryngology, Head and Neck Surgery Gour Shasha Tower Building, floor#7 | Petah tikva | |
| Serbia | Clinical Hospital Center Dr Dragisa Misovic-Dedinje | Belgrade | |
| Serbia | Clinical Center of Vojvodina | Novi Sad | |
| Slovakia | MUDr. Igor Kažmér, s.r.o. | Liptovský Mikuláš | |
| Slovakia | Fakultna nemocnica s poliklinikou J. A. Reimana Presov, Oddelenie otorinolaryngologie a chirurgie hlavy a krku | Prešov | |
| Turkey | Istanbul Medeniyet University Goztepe Training and Research Hospital, Department of Ear,Nose,Throat | Istanbul | |
| Turkey | Erciyes University Medical Faculty Department of Ear Nose Throat | Melikgazi | |
| United Kingdom | The Royal Hallamshire Hospital | Sheffield |
| Lead Sponsor | Collaborator |
|---|---|
| Sensorion |
Bulgaria, Canada, Czechia, France, Germany, Israel, Serbia, Slovakia, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. |
28 days | |
| Secondary | 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. |
Day 28 | |
| Secondary | 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. |
Day 28 | |
| Secondary | 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. |
Day 84 | |
| Secondary | 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. | Day 28 | |
| Secondary | 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. | Day 84 |