EUCTR2016-003927-45-ES进行中（未招募）1 期
A multicentre, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of 2 dose regimens of orally administered SENS-111 (100mg and 200mg) given during 4 days in patients suffering from Acute Unilateral Vestibulopathy
适应症
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
- 207
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. Male or female patients
- •2. Aged =18 years and <75 years
- •3. Suffering from an acute episode of vertigo of peripheral origin defined as:
- •a.Severe (= 60mm on the standing vertigo intensity visual analog scale)
- •b.Prolonged (more than 6 hours),
- •c.Associated with imbalance (and/or postural imbalance) and nausea (and/or vomiting)
- •d.Spontaneous nystagmus toward the unaffected ear (fast phase) which is suppressed or reduced by visual fixation confirmed by oculography
- •e.Gain of the vestibulo ocular reflex (VOR) <0.7, measured by the video- head impulse test (HIT) and/or difference between the 2 labyrinths >25% according to the caloric test (de Jongkees’ formula).
- •4. Affiliated or is a beneficiary to a health insurance system (if applicable in the national regulations)
- •5. 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 104
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 103
排除标准
- •1.Vertigo duration of less than 6 hours before randomization
- •2.Acute continuous vertigo lasting more than 72 hours prior to randomization
- •3.Acute hearing loss during or after the onset of vertigo.
- •4.Acute unilateral tinnitus during or after the onset of vertigo
- •5.History of acute or chronic vestibular diseases (including Ménière’s disease, acute labyrinthitis, vestibular migraine...), vestibular dysfunction, previous episode of acute unilateral vestibulopathy or prolonged vertigo.
- •6.Ongoing Benign paroxysmal positional vertigo (BPPV)
- •7.History of prior acute central vestibular lesion.
- •8.Acute or chronic disease of middle ear (infections, otitis)
- •9.Concurrent Varicella Zoster Virus (VZV) ear infection (Herpes zoster oticus)
- •10.History of cochlear implants
- •11.Neurological disorders including stroke, brainstem or cerebellar dysfunction within the last 3 months (In case of possible stroke of the brainstem or cerebellum, the diagnosis should have been excluded by a MRI performed in the past 48 hours)
- •12.Past or concomitant treatment with ototoxic chemotherapy
- •13.Past history of seizures or convulsions
- •14.Head trauma within the last 10 days prior to randomization
- •15.Aminoglycosides in the past 6 months given via systemic or transtympanic administration
- •16.Concomitant treatment with any of the followings within the last 24 hours prior to randomization if more than 2 doses have been taken:
- •a.Antihistamines: diphenhydramine, cyclizine, dimenhydrinate, meclizine, hydroxyzine, promethazine,
- •b.Cinnarizine, flunarizine
- •c.Central anti-dopaminergics: neuroleptics, unless the dose is stable for at least 1 month prior to randomization and no changes are expected during the course of the study
- •d.Benzodiazepines
- •e.Histaminergics (e.g., betahistine)
- •f.Scopolamine, homatropine
- •g.Gabapentin, pregabalin
- •h.Acetylleucine, 5HT3 antagonists (ondensetron, granisetron, palonosetron etc..)
- •i.Piracetam, piribedil, trimetazidine,
- •j.Corticosteroids (oral or injectable) unless the dose is stable for at least 1 month prior to randomization and no changes are expected during the course of the study
- •17.Treatment with any investigational agent within 4 weeks prior to randomization or 5 half-lives of the investigational drug (whichever is longer)
- •18.Prior participation in a clinical trial with SENS-111
- •19.History of malignancy other than effectively treated carcinoma in-situ of the cervix, or adequately treated non-metastatic squamous or basal cell carcinoma of the skin, within 5 years
- •20.Known history of, or concomitant severe hepatic, gastrointestinal, cardiovascular, respiratory, neurological, psychiatric, hematological, renal, or dermatological disease, or any condition, psychiatric, substance abuse, or otherwise, that, in the opinion of the Investigator might interfere with the evaluation of study treatment or warrant exclusion.
- •21.Pregnancy (a negative pregnancy test is required for all women of childbearing potential (WOCBP) before initiation of trea
研究者
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