EUCTR2018-000812-47-GB进行中（未招募）1 期
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 - AUDIBLE-S
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- SENSORION SA
- 入组人数
- 458
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1 Male or female
- •2 Aged at least 18 years old
- •3 Patients with unilateral idiopathic sudden sensorineural hearing loss or unilateral/bilateral acute acoustic trauma leading to sudden sensorineural hearing loss defined by both
- •3.1. At least 1 hearing threshold of 50 dB or more amongst the 3 most affected contiguous frequencies on pure tone audiometric air conduction
- •testing performed 24 hours or less prior to first study treatment,
- •3.2 Mean hearing loss of 30 dB or more, averaged across the 3 most affected contiguous frequencies on pure tone audiometric air conduction
- •testing (PTA: Pure Tone Average) performed 24 hours or less prior to first study treatment, compared with the unaffected contralateral ear or
- •reference values from a pre-existing audiogram (dated less than 2 years)
- •4 Patients with sudden hearing loss with onset within 96 hours prior to first study drug intake.
- •5 Females must meet one of the following: postmenopausal defined as 12 consecutive months with no menses without an alternative medical
- •cause, surgically sterile, abstinent; or practicing highly effective birth control (must agree to use 2 forms of contraception [1 of which must be a barrier method]) (Appendix 4) and willing to continue to use highly effective contraception for the duration of study participation and for 30 days after the final dose of study drug). Women of childbearing potential must have a negative pregnancy test at screening before the first dose of study drug is taken. Women of childbearing potential are defined as any female who has experienced menarche and who is not permanently sterile or postmenopausal.
- •6 Male subjects and their female partner(s) must agree to use highly effective contraception (must agree to use 2 forms of contraception [1 of which must be a barrier method]) (Appendix 4) for the duration of study participation and for 90 days after the final dose of study drug.
- •7 Signed and dated written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 275
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 183
排除标准
- •1.Bilateral idiopathic hearing loss
- •2.Fluctuating hearing loss
- •3.History of asymetric hearing (>20dB difference between ears) to the best knowledge of the patient
- •4.Severe hearing loss (>90 dB) associated with unilateral (ipsilateral) complete vestibular loss
- •5.History of Ménière’s disease, autoimmune hearing loss, radiation-induced hearing loss, acoustic neuroma (schwannoma)
- •6.Previous SSNHL in the affected ear within the past 6 weeks
- •7.History of otosclerosis, suspected perilymph fistula or membrane rupture, suspected retro-cochlear lesion, barotrauma
- •8.Congenital or hereditary hearing loss
- •9. History of severe head or neck trauma
- •10. Complete loss of peripheral vestibular function on the affected side
- •11. Any drug-based therapy for inner ear hearing loss that is ongoing or
- •was performed in the past 6 weeks, except oral corticosteroids
- •12. Any ongoing or planned concomitant medication for the treatment
- •of tinnitus until 6 weeks after administration
- •13. Any therapy known as ototoxic (e.g. aminoglycosides, cisplatin,
- •loop diuretics, quinine etc.) at the current time or in the past 6 months
- •prior to study inclusion
- •14. Air-bone gap of greater than 20 dB in 3 contiguous frequencies
- •15. Acute chronic otitis media or otitis externa terminated less than 7
- •days prior to randomisation.
- •16. History of chronic inflammatory or suppurative ear disease or
- •cholesteatoma,
- •17. Prior ear surgery of any kind (except ventilating tubes), or cochlear
- •18. Patients with moderate to severe renal impairment defined by a
- •creatinine clearance = 60 ml/min (calculated using the Cockroft-Gault
- •19. Treatment with triptans within the 24 hours before inclusion.
- •20. History of drug abuse or alcoholism within the last 2 years
- •21. Known or suspected ongoing active infection of HIV, Hepatitis B or
- •C, or herpes zoster
- •22. Known history of, or concomitant severe hepatic, gastrointestinal,
- •cardiovascular, respiratory, neurological (except vertigo or tinnitus),
- •hematological, renal, dermatological or psychiatric disease or substance
- •abuse or any condition that, in the opinion of the Investigator might
- •interfere with the evaluation of study treatment or warrant exclusion (see list of discontinuation criteria, section 11.3.2)
- •23. Patients who, in the opinion of the Investigator, have any clinically
- •relevant findings that warrant exclusion. Examples of clinically relevant
- •problems include, but are not limited to, serious non-malignancyassociated
- •medical conditions that may be expected to limit life
- •expectancy or significantly increase the risk of SAEs and any condition,
- •psychiatric, substance abuse, or otherwise, that, in the opinion of the
- •Investigator, would preclude informed consent, consistent follow-up, or
- •compliance with any aspect of the study
- •24. Neurological disorders including stroke, demyelinating disease,
- •brain stem or cerebellar dysfunction within the last 3 months. (In case
- •of possible stroke of the brainstem or cerebellum, or demyelinating
- •disease the diagnosis should have been excluded by a MRI performed in
- •the past 48 hours)
- •25. Known hypersensitivity, allergy or intolerance to the study
- •medication or any history of severe abnormal drug reaction
- •26. Pregnant or breast-feeding
- 另有 4 项未显示
研究者
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