Efficacy of SENS 401 in Subjects With Severe or Profound Sudden Sensorineural Hearing Loss (AUDIBLE-S)

S

Sensorion

Status and phase

Completed
Phase 3
Phase 2

Conditions

Severe Sudden Sensorineural Hearing Loss

Treatments

Other: Placebo Oral Tablet
Drug: SENS-401

Study type

Interventional

Funder types

Industry

Identifiers

NCT03603314
SENS 401-201

Details and patient eligibility

About

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

Full 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".

Enrollment

115 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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...).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

115 participants in 3 patient groups, including a placebo group

29 mg dose group
Experimental 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.
Treatment:
Drug: SENS-401
43.5 mg dose group
Experimental 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.
Treatment:
Drug: SENS-401
placebo oral tablet
Placebo Comparator group
Description:
Patients will receive the study drug (placebo) in the form of tablets by mouth, twice a day, during the first 4 weeks after randomization.
Treatment:
Other: Placebo Oral Tablet

Trial documents
2

Trial contacts and locations

26

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems