EUCTR2018-001464-35-GB进行中（未招募）1 期
A prospective, randomized, double blind, placebo-controlled, multicenter, Phase 3 efficacy and safety study of OTO-104 given as a single intratympanic injection in subjects with unilateral Meniere’s disease.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 180
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
入选标准
- •1. Subject is a male or female aged 18 to 85 years, inclusive.
- •2. Subject has a diagnosis of definite unilateral Meniere's disease by 1995 AAO-HNS criteria.
- •3. Subject self-reports active, definitive vertigo episodes for the 2 months prior to the study lead-in period.
- •4. Subject has documented asymmetric sensorineural hearing loss at screening or within the past 12 months according to 1995 AAO-HNS criteria defined as one of the following:
- •a. The arithmetic mean of hearing thresholds (pure tone average, PTA) at 250, 500 and 1000 Hz of 15 dB or more higher than the PTA of 1000, 2000, and 3000 Hz,
- •b. The arithmetic mean of PTA at 500, 1000, 2000 and 3000 Hz is 20 dB or more poorer in the ear in question than on the opposite side,
- •c. It is the judgment of the Investigator that the subject's hearing loss meets reasonable audiometric criteria for hearing loss characteristic of Meniere's disease, and if so, it must be justified and documented, and discussed with the medical monitor.
- •5. If taking medication for Meniere’s disease (e.g., diuretics, vestibular suppressants, betahistine, antidepressants, or anxiolytics), subject must be on stable doses of the medication for at least 2 weeks prior to Screening and agrees to remain on stable doses of the medication for the duration of the study.
- •6. Female subjects of childbearing potential [i.e., not surgically sterile and/or not postmenopausal (=12 months since last menstrual period and 45 years of age or older)] must have a negative urine pregnancy test before randomization. Women of childbearing potential who are not abstinent from sex with male partners may be entered into the study if they are using and willing to continue to use highly effective or double barrier”
- •contraceptive precautions for the duration of the study (e.g., oral contraceptives, contraceptive implant or injection, intrauterine device, double barrier” methods including male condom with diaphragm, male condom with cervical cap, male condom with spermicide, or diaphragm and spermicide).
- •7. Subject is willing to comply with the protocol and attend all study visits.
- •8. Subject is able to use the telephone to complete their daily diary.
- •9. Subject is able to provide written informed consent, including agreement to privacy language compliant with country and/or local requirements, before the initiation of any study-related procedures.
- •At the completion of the first 28 days of the lead-in period:
- •10. Subject has experienced and recorded at least 4 and a maximum of 22 definitive vertigo days during the 4-week lead-in period.
- •11. Subject completed at least 22 of 28 diary entries during the 4-week lead-in period.
- •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 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1. Subject has an infection in the ear, sinuses, or upper respiratory system at the time of randomization.
- •2. Subject is pregnant or lactating.
- •3. Subject has a history of immunodeficiency disease.
- •4. Subject has active or recent (<1 month prior to screening) middle ear disease, including but not limited to: chronic otitis media, acute otitis media, middle ear effusions, middle ear atelectasis, or cholesteatoma.
- •5. Subject has an abnormality of the tympanic membrane in the affected ear that would increase the risk associated with intratympanic injection including but not limited to monomeric tympanic membrane.
- •6. Subject has a history of significant middle ear or inner ear surgery, or endolymphatic sac surgery in the affected ear.
- •7. Subject has a history of previous use of intratympanic gentamicin in the affected ear.
- •8. Subject has a history of tympanostomy tubes with evidence of perforation or lack of closure in the affected ear.
- •9. Subject has used systemic steroids within 1 month prior to entering the lead-in period.
- •10. Subject has a history of previous use of intratympanic steroids in the affected ear.
- •11. Subject has experienced an adverse reaction to dexamethasone
- •12. Subject has a history of vestibular migraine. International Classification of Headache Disorders III criteria for vestibular migraine includes a current or past history of migraine with or without aura, vestibular symptoms of moderate or severe intensity lasting between 5 minutes and 72 hours, and at least half of episodes are associated with at least 1 of the 4 following migrainous features: unilateral headache, pulsating quality, photophobia, and visual aura.
- •13. Subject has history of drop attacks.
- •14. Subject is not able to accurately identify and report episodes of vertigo.
- •15. Subject has any other clinically significant illness, medical condition, or medical history that, in the Investigator’s or the medical monitor’s opinion, would prohibit the subject from participating in the study at screening or at the time of randomization.
- •16. Subject has used an investigational drug or device in the 3 months prior to screening.
- •17. Subject has a history of serious substance abuse (e.g. cocaine, heroin) within the preceding 6 months prior to screening.
- •18. Subject has previously been randomized to a clinical study of OTO-104.
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