Efficacy of SENS 401 in Subjects With Severe or Profound Sudden Sensorineural Hearing Loss
- Conditions
- Severe Sudden Sensorineural Hearing Loss
- Interventions
- Other: Placebo Oral Tablet
- Registration Number
- NCT03603314
- Lead Sponsor
- Sensorion
- 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".
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 115
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 29 mg dose group SENS-401 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. 43.5 mg dose group SENS-401 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. placebo oral tablet 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.
- Primary Outcome Measures
Name Time Method 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). 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.
- Secondary Outcome Measures
Name Time Method 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). Day 28 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 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 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). Day 28 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). Day 84 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 84 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.
Trial Locations
- Locations (26)
CHU de Quebec - Centre Hospitalier de l'Universite Laval
🇨🇦Québec, Canada
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, Czechia
43ème Antenne Médicale de Sarrebourg
🇫🇷Sarrebourg, France
Hillel Yaffe Medical Center
🇮🇱Hadera, Israel
Rambam Medical Center Health Care Campus
🇮🇱Haifa, Israel
Clinical Center of Vojvodina
🇷🇸Novi Sad, Serbia
MUDr. Igor Kažmér, s.r.o.
🇸🇰Liptovský Mikuláš, Slovakia
The Royal Hallamshire Hospital
🇬🇧Sheffield, United Kingdom
109ème Antenne Médicale de Saint-Maixent l'école
🇫🇷Saint-Maixent-l'École, France
Istanbul Medeniyet University Goztepe Training and Research Hospital, Department of Ear,Nose,Throat
🇹🇷Istanbul, Turkey
Hôpital Lariboisière
🇫🇷Paris, France
Hôpital Pierre Paul Riquet- CHU Purpan
🇫🇷Toulouse, France
MI Minisrty of Interior Affair Sofia Clinic of Otorhinolaryngology
🇧🇬Sofia, Bulgaria
Rabin Medical Center, Otolaryngology, Head and Neck Surgery Gour Shasha Tower Building, floor#7
🇮🇱Petah tikva, Israel
Fakultna nemocnica s poliklinikou J. A. Reimana Presov, Oddelenie otorinolaryngologie a chirurgie hlavy a krku
🇸🇰Prešov, Slovakia
Military Medical Academy; Clinic of Otorhynolaryngology
🇧🇬Sofia, Bulgaria
Hôpital d'Instruction des Armées Percy
🇫🇷Clamart, France
Hôpital Européen
🇫🇷Marseille, France
Multiprofile Hospital for Active Treatment Burgas AD Department of Otorhynolaryngology
🇧🇬Burgas, Bulgaria
Wall Street ENT Clinic
🇨🇦Saskatoon, Canada
Clinical Hospital Center Dr Dragisa Misovic-Dedinje
🇷🇸Belgrade, Serbia
Hôpital d'Instruction des armées SAINTE ANNE
🇫🇷Toulon, France
Universitätsklinikum Tübingen Klinik für Hals-, Nasen- u. Ohrenheilkunde Plastische Operationen
🇩🇪Tübingen, Germany
Erciyes University Medical Faculty Department of Ear Nose Throat
🇹🇷Melikgazi, Turkey
Lady Davis Carmel Medical Center
🇮🇱Haifa, Israel