Brief Title
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
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".
Study Phase
Phase 2/Phase 3
Study Type
Interventional
Primary Outcome
Change in pure tone audiometry PTA (dB)
Condition
Severe Sudden Sensorineural Hearing Loss
Intervention
SENS-401
Study Arms / Comparison Groups
29 mg dose group
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
458
Start Date
February 15, 2019
Completion Date
August 30, 2022
Primary Completion Date
June 30, 2021
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...).
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Géraldine HONNET, MD, +33(0)786676542, [email protected]
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT03603314
Organization ID
SENS 401-201
Responsible Party
Sponsor
Study Sponsor
Sensorion
Study Sponsor
Géraldine HONNET, MD, Study Director, Sensorion
Verification Date
October 2020