Phase 3
Completed N=115
Efficacy of SENS 401 in Subjects With Severe or Profound Sudden Sensorineural Hearing Loss
Severe Sudden Sensorineural Hearing Loss
Source: ClinicalTrials.gov NCT03603314 ↗
Enrolled (actual)
115
Serious AEs
2.6%
Results posted
Mar 2023
Primary outcomePrimary: 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). — -27.754; -24.931; -25.214 dB — p=0.3419
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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). |
-27.754; -24.931; -25.214 | 0.3419 |
| SECONDARY 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). |
-27.910; -24.468; -25.726 | 0.3666 |
| SECONDARY 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). |
-30.889; -30.035; -29.371 | 0.4094 |
| SECONDARY 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). |
-32.469; -30.070; -25.399 | 0.1269 |
| SECONDARY Change in Speech Discrimination Threshold From Baseline to Day 28 |
-22.899; -19.882; -19.827 | 0.3121 |
| SECONDARY Change in Speech Discrimination Threshold From Baseline to Day 84 |
-24.990; -22.671; -16.642 | 0.0976 |
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...).
Data sourced from ClinicalTrials.gov (NCT03603314). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.