EUCTR2011-003412-23-CZ进行中（未招募）不适用
EFFECT OF V0251 IN ACUTE VERTIGO.A RANDOMISED DOUBLE-BLIND PLACEBO CONTROLLED STUDY.
Pierre Fabre Médicament - IRPF0 个研究点目标入组 132 人开始时间: 2011年12月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 132
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
- •- Age 18 to 70 years, included
- •- Acute vertigo attack due to vestibular disorder that began within 48 hours before the inclusion
- •- Vertigo sensation lasting more than 20 min
- •- At least one vertigo symptom of strong intensity (=3 on the VAS ranging 0-4) on the intensity vertigo scale (see section 17.4 for details) at the moment of the inclusion
- •- For woman of child bearing potential: negative urine or serum pregnancy test at inclusion and using an efficient contraceptive (surgical or hormonal birth control or intra-uterine device) for at least 2 months before the study and one month after the end of the study, in order to avoid pregnancy while being exposed to the study treatment
- •- Able to understand the protocol and having signed the written Informed Consent Form. In case of intense vertigo, the informed consent may be signed by a third party (a trustworthy person except an investigator’s team representative or a sponsor representative) after oral consent of the patient, the Informed Consent Form then being signed by the patient before the end of the study.
- •- Likely to be compliant during the study, in the judgement of the investigator
- •- Affiliated to the social security system, or is a beneficiary, if applicable in national regulation
- •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 119
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 13
排除标准
- •Relating to pathologies:
- •- Signs of brain, brainstem and/or cerebellar dysfunction (e.g. perioral hypoesthesia, facial paresis/palsy, dysphagia, dysarthria, limb paresis and/or hypoesthesia, coordination deficit, confusion/loss of consciousness)
- •- Concomitant central neurological disorder that may involve vertigo or dizziness (e.g. multiple sclerosis, epilepsy, Parkinson’s disease, Arnold-Chiari’s disease, Wallenberg’s disease)
- •- Psychogenic vertigo (e.g. vertigo associated with an evident psychiatric disease, postural phobic vertigo, vertigo induced by a conflict or a stress situation, simulation)
- •- Patient with history of hypersensitivity to acetylleucine or excipients
- •- Narrow angle glaucoma
- •- Moderate to severe prostatic hypertrophy or bladder neck obstruction
- •- Any medical history of major medical, psychiatric illness or surgery which, in the judgement of the investigator, could jeopardize his / her health.
- •Relating to treatments:
- •- Use of ototoxic drugs causing vertigo or dizziness (gentamicin, streptomycin, quinine, mefloquine, methotrexate) within the last month
- •- Use of Acetylleucine by oral route within the last 2 weeks
- •- Use of Acetylleucine by IV route within the last 6 hours prior to baseline evaluations
- •- Use of the following medications within the last 12 hours prior to baseline evaluations, except if the dosage had been stable for at least 3 months:
- •- Antihistamines: diphenhydramine, cyclizine, dimenhydrinate, meclozine, hydroxyzine, promethazine
- •- Calcium antagonists: cinnarizine, flunarizine
- •- Central antidopaminergics : phenothiazines, thioxanthenes, butyrophenones, benzamides, diazepines, oxazepines, aripiprazole, pimozide, risperidone
- •- Peripheral antidopaminergics: metoclopramide, alizapride
- •- Histaminergics: betahistine
- •- Anticholinergics: scopolamine (hyoscine), homatropine
- •- GABA agonists: gabapentin, pregabalin
- •- Ondansetron
- •- Piribedil, piracetam, trimetazidine, ginkgo biloba
- •- Acetazolamide
- •- Oral steroids
- •- Use of antiepileptic drugs (except GABA agonists if the dosage had been stable for at least 3 months)
- •Relating to the population:
- •- Is a family member or work associate (secretary, nurse, technician,…) of the Investigator
- •- Is pregnant or in post-partum period or a nursing mother
- •- Has received treatment with known persistent effects or undergone investigation liable to interfere with the present clinical trial
- •- Mentally unable to understand the nature, objectives and possible consequences of the trial; or refusing its constraints
- •- Has forfeited his / her freedom by administrative or legal award or is under guardianship
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