Clinical trial NCT03603314: Efficacy of SENS 401 in Subjects With Severe or Profound Sudden Sensorineural Hearing Loss
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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Severe Sudden Sensorineural Hearing Loss
Lead sponsor: Sensorion
Sponsor class: INDUSTRY
First posted: 2018-07-27
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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".

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...).

Primary outcomes:
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).
timeFrame: 28 days
Secondary outcomes:
measure: 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).
timeFrame: Day 28
measure: 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).
timeFrame: Day 28
measure: 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).
timeFrame: Day 84
measure: Change in Speech Discrimination Threshold From Baseline to Day 28
timeFrame: Day 28
measure: Change in Speech Discrimination Threshold From Baseline to Day 84
timeFrame: Day 84
Other outcomes:
Locations:
city: Burgas
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Burgas AD Department of Otorhynolaryngology
city: Sofia
country: Bulgaria
facility: MI Minisrty of Interior Affair Sofia Clinic of Otorhinolaryngology
city: Sofia
country: Bulgaria
facility: Military Medical Academy; Clinic of Otorhynolaryngology
city: Québec
country: Canada
facility: CHU de Quebec - Centre Hospitalier de l'Universite Laval
city: Saskatoon
country: Canada
facility: Wall Street ENT Clinic
city: Brno
country: Czechia
facility: Fakultni nemocnice u sv. Anny v Brne-Klinika otorinolaryngologie a chirurgie hlavy a krku
city: Hradec Králové
country: Czechia
facility: Fakultni nemocnice Hradec Kralove -Klinika otorinolaryngologie a chirurgie hlavy a krku
city: Clamart
country: France
facility: Hôpital d'Instruction des Armées Percy
city: Marseille
country: France
facility: Hôpital Européen
city: Paris
country: France
facility: Hôpital Lariboisière
city: Saint-Maixent-l'École
country: France
facility: 109ème Antenne Médicale de Saint-Maixent l'école
city: Sarrebourg
country: France
facility: 43ème Antenne Médicale de Sarrebourg
city: Toulon
country: France
facility: Hôpital d'Instruction des armées SAINTE ANNE
city: Toulouse
country: France
facility: Hôpital Pierre Paul Riquet- CHU Purpan
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen Klinik für Hals-, Nasen- u. Ohrenheilkunde Plastische Operationen
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Center Health Care Campus
city: Haifa
country: Israel
facility: Lady Davis Carmel Medical Center
city: Petah tikva
country: Israel
facility: Rabin Medical Center, Otolaryngology, Head and Neck Surgery Gour Shasha Tower Building, floor#7
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Dr Dragisa Misovic-Dedinje
city: Novi Sad
country: Serbia
facility: Clinical Center of Vojvodina
city: Liptovský Mikuláš
country: Slovakia
facility: MUDr. Igor Kažmér, s.r.o.
city: Prešov
country: Slovakia
facility: Fakultna nemocnica s poliklinikou J. A. Reimana Presov, Oddelenie otorinolaryngologie a chirurgie hlavy a krku
city: Istanbul
country: Turkey
facility: Istanbul Medeniyet University Goztepe Training and Research Hospital, Department of Ear,Nose,Throat
city: Melikgazi
country: Turkey
facility: Erciyes University Medical Faculty Department of Ear Nose Throat
city: Sheffield
country: United Kingdom
facility: The Royal Hallamshire Hospital
Study officials:
affiliation: Sensorion
name: Géraldine HONNET, MD
role: STUDY_DIRECTOR
References: