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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
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".
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SENS-401 | Drug | 29 mg dose group: tablets of 14.5 mg, oral route, by mouth, twice a day, during 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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The main criteria for inclusion:
The main criteria for exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Géraldine HONNET, MD | Sensorion | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiprofile Hospital for Active Treatment Burgas AD Department of Otorhynolaryngology | Burgas | 8000 | Bulgaria | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 43.5 mg Dose Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 5, 2021 | Dec 22, 2022 |
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| Placebo Oral Tablet | Other | placebo, oral route, by mouth, twice a day, during 4 weeks |
|
| SENS-401 | Drug | 43.5 mg dose groupe: tablets of 14.5 mg, oral route, by mouth, twice a day, during 4 weeks |
|
| 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. | 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. | 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. | 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. | Day 84 |
| MI Minisrty of Interior Affair Sofia Clinic of Otorhinolaryngology |
| Sofia |
| 1606 |
| Bulgaria |
| Military Medical Academy; Clinic of Otorhynolaryngology | Sofia | 1606 | Bulgaria |
| CHU de Quebec - Centre Hospitalier de l'Universite Laval | Québec | G1V 4G2 | Canada |
| Wall Street ENT Clinic | Saskatoon | S7K 1N4 | 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 |
| Hôpital d'Instruction des Armées Percy | Clamart | 92140 | France |
| Hôpital Européen | Marseille | 13003 | France |
| Hôpital Lariboisière | Paris | 75475 | France |
| 109ème Antenne Médicale de Saint-Maixent l'école | Saint-Maixent-l'École | 79400 | France |
| 43ème Antenne Médicale de Sarrebourg | Sarrebourg | 57404 | France |
| Hôpital d'Instruction des armées SAINTE ANNE | Toulon | 83000 | France |
| Hôpital Pierre Paul Riquet- CHU Purpan | Toulouse | 31059 | France |
| Universitätsklinikum Tübingen Klinik für Hals-, Nasen- u. Ohrenheilkunde Plastische Operationen | Tübingen | 72076 | Germany |
| Hillel Yaffe Medical Center | Hadera | 38100 | Israel |
| Rambam Medical Center Health Care Campus | Haifa | 3109601 | Israel |
| Lady Davis Carmel Medical Center | Haifa | 3436212 | Israel |
| Rabin Medical Center, Otolaryngology, Head and Neck Surgery Gour Shasha Tower Building, floor#7 | Petah Tikva | 4341492 | Israel |
| Clinical Hospital Center Dr Dragisa Misovic-Dedinje | Belgrade | 11000 | Serbia |
| Clinical Center of Vojvodina | Novi Sad | 21000 | Serbia |
| MUDr. Igor Kažmér, s.r.o. | Liptovský Mikuláš | 03101 | Slovakia |
| Fakultna nemocnica s poliklinikou J. A. Reimana Presov, Oddelenie otorinolaryngologie a chirurgie hlavy a krku | Prešov | 08001 | Slovakia |
| Istanbul Medeniyet University Goztepe Training and Research Hospital, Department of Ear,Nose,Throat | Istanbul | 34722 | Turkey (Türkiye) |
| Erciyes University Medical Faculty Department of Ear Nose Throat | Melikgazi | 38039 | Turkey (Türkiye) |
| The Royal Hallamshire Hospital | Sheffield | S10 2JF | United Kingdom |
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 |
| FG002 | 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 |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Least Squares Mean | 90% Confidence Interval | dB | 28 days |
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| 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. | Posted | Least Squares Mean | 90% Confidence Interval | dB | Day 28 |
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| 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. | Posted | Least Squares Mean | 90% Confidence Interval | dB | Day 28 |
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| 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. | Posted | Least Squares Mean | 90% Confidence Interval | dB | Day 84 |
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| 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. | Posted | Least Squares Mean | 90% Confidence Interval | dB | Day 28 |
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| 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. | Posted | Least Squares Mean | 90% Confidence Interval | dB | Day 84 |
|
84 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 38 | 1 | 38 | 20 | 38 |
| EG001 | 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 | 0 | 39 | 1 | 39 | 13 | 39 |
| EG002 | 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 | 0 | 38 | 1 | 38 | 4 | 38 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| diziness | Nervous system disorders | MeDRA | Non-systematic Assessment |
| |
| fatigue | General disorders | MeDRA 24.1 | Non-systematic Assessment |
| |
| headache | Nervous system disorders | MeDRA 24.1 | Non-systematic Assessment |
| |
| colon neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MeDRA 24.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MeDRA 24.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MeDRA 24.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MeDRA 24.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MeDRA 24.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MeDRA 24.1 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MeDRA 24.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MeDRA 24.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MeDRA 24.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MeDRA 24.1 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MeDRA 24.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Regulatory Affairs | Sensorion | +33467207720 | contact@sensorion-pharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 6, 2021 | Dec 22, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003639 | Hearing Loss, Sudden |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000656584 | SENS-401 |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| White |
|
| Unknown |
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| Race |
|
The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP <0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP <0 (greater decrease on low dose) |
| Mixed Models Analysis |
| 0.5181 |
| Superiority |
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
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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
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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
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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 |
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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 |
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