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

NCT03603314 | Completed Phase 2 Results FDA Drug

• 1 other identifier: SENS 401-201
• Study Type: interventional
• Target: 115
• Locations: 10 countries
• Sites: 26

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

Conditions

Severe Sudden Sensorineural Hearing Loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• 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

• 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

• Change in Speech Discrimination Threshold From Baseline to Day 28

  Day 28

• Change in Speech Discrimination Threshold From Baseline to Day 84

  Day 84

Study Arms (3)

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.

Drug: SENS-401

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.

Drug: SENS-401

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.

Other: Placebo Oral Tablet

Interventions

SENS-401 DRUG

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

29 mg dose group

Placebo Oral Tablet OTHER

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

placebo oral tablet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sensorion: lead

Study Sites (26)

Multiprofile Hospital for Active Treatment Burgas AD Department of Otorhynolaryngology

Burgas, 8000, Bulgaria

Location

MI Minisrty of Interior Affair Sofia Clinic of Otorhinolaryngology

Sofia, 1606, Bulgaria

Location

Military Medical Academy; Clinic of Otorhynolaryngology

Sofia, 1606, Bulgaria

Location

CHU de Quebec - Centre Hospitalier de l'Universite Laval

Québec, G1V 4G2, Canada

Location

Wall Street ENT Clinic

Saskatoon, S7K 1N4, Canada

Location

Fakultni nemocnice u sv. Anny v Brne-Klinika otorinolaryngologie a chirurgie hlavy a krku

Brno, Czechia

Location

Fakultni nemocnice Hradec Kralove -Klinika otorinolaryngologie a chirurgie hlavy a krku

Hradec Králové, Czechia

Location

Hôpital d'Instruction des Armées Percy

Clamart, 92140, France

Location

Hôpital Européen

Marseille, 13003, France

Location

Hôpital Lariboisière

Paris, 75475, France

Location

109ème Antenne Médicale de Saint-Maixent l'école

Saint-Maixent-l'École, 79400, France

Location

43ème Antenne Médicale de Sarrebourg

Sarrebourg, 57404, France

Location

Hôpital d'Instruction des armées SAINTE ANNE

Toulon, 83000, France

Location

Hôpital Pierre Paul Riquet- CHU Purpan

Toulouse, 31059, France

Location

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

Tübingen, 72076, Germany

Location

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

Rambam Medical Center Health Care Campus

Haifa, 3109601, Israel

Location

Lady Davis Carmel Medical Center

Haifa, 3436212, Israel

Location

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

Petah Tikva, 4341492, Israel

Location

Clinical Hospital Center Dr Dragisa Misovic-Dedinje

Belgrade, 11000, Serbia

Location

Clinical Center of Vojvodina

Novi Sad, 21000, Serbia

Location

MUDr. Igor Kažmér, s.r.o.

Liptovský Mikuláš, 03101, Slovakia

Location

Fakultna nemocnica s poliklinikou J. A. Reimana Presov, Oddelenie otorinolaryngologie a chirurgie hlavy a krku

Prešov, 08001, Slovakia

Location

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

Istanbul, 34722, Turkey (Türkiye)

Location

Erciyes University Medical Faculty Department of Ear Nose Throat

Melikgazi, 38039, Turkey (Türkiye)

Location

The Royal Hallamshire Hospital

Sheffield, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Hearing Loss, Sudden

Interventions

SENS-401

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Director of Regulatory Affairs
• Organization: Sensorion

contact@sensorion-pharma.com

+33467207720

Study Officials

• Géraldine HONNET, MD

  Sensorion

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2018
• First Posted: July 27, 2018
• Study Start: February 15, 2019
• Primary Completion: November 4, 2021
• Study Completion: January 12, 2022
• Last Updated: March 1, 2023
• Results First Posted: March 1, 2023

Record last verified: 2022-12

Locations

CZ (2); IL (4); SL (2); TU (2); DE (1); BU (3); CA (2); SE (2); GB (1); FR (7)