Efficacy of SENS 401 in Subjects With Severe or Profound Sudden Sensorineural Hearing Loss

NCT ID: NCT03603314

Last Updated: 2023-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-15
• Study Completion Date: 2022-01-12

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".

Conditions

Severe Sudden Sensorineural Hearing Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

SENS-401

Intervention Type: DRUG

29 mg dose group: tablets of 14.5 mg, oral route, by mouth, twice a day, during 4 weeks

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.

Group Type: EXPERIMENTAL

SENS-401

Intervention Type: DRUG

43.5 mg dose groupe: tablets of 14.5 mg, oral route, by mouth, twice a day, during 4 weeks

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.

Group Type: PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type: OTHER

placebo, oral route, by mouth, twice a day, during 4 weeks

Interventions

SENS-401

29 mg dose group: tablets of 14.5 mg, oral route, by mouth, twice a day, during 4 weeks

Intervention Type: DRUG

Placebo Oral Tablet

placebo, oral route, by mouth, twice a day, during 4 weeks

Intervention Type: OTHER

SENS-401

43.5 mg dose groupe: tablets of 14.5 mg, oral route, by mouth, twice a day, during 4 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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...).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sensorion

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Géraldine HONNET, MD

Role: STUDY_DIRECTOR

Sensorion

Locations

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, , Bulgaria

CHU de Quebec - Centre Hospitalier de l'Universite Laval

Québec, , Canada

Wall Street ENT Clinic

Saskatoon, , 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, , 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, , France

Universitätsklinikum Tübingen Klinik für Hals-, Nasen- u. Ohrenheilkunde Plastische Operationen

Tübingen, , Germany

Hillel Yaffe Medical Center

Hadera, , Israel

Rambam Medical Center Health Care Campus

Haifa, , Israel

Lady Davis Carmel Medical Center

Haifa, , Israel

Rabin Medical Center, Otolaryngology, Head and Neck Surgery Gour Shasha Tower Building, floor#7

Petah Tikva, , Israel

Clinical Hospital Center Dr Dragisa Misovic-Dedinje

Belgrade, , Serbia

Clinical Center of Vojvodina

Novi Sad, , Serbia

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, , Slovakia

Istanbul Medeniyet University Goztepe Training and Research Hospital, Department of Ear,Nose,Throat

Istanbul, , Turkey (Türkiye)

Erciyes University Medical Faculty Department of Ear Nose Throat

Melikgazi, , Turkey (Türkiye)

The Royal Hallamshire Hospital

Sheffield, , United Kingdom

Countries

Bulgaria; Canada; Czechia; France; Germany; Israel; Serbia; Slovakia; Turkey (Türkiye); United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

SENS 401-201

Identifier Type: -

Identifier Source: org_study_id