EUCTR2009-013701-34-DE进行中（未招募）1 期
Prophylactic treatment of vestibular migraine with metoprolol: a double-blind, placebo- controlled trial - PROVEMIG
Hospital of the University of Munich0 个研究点目标入组 266 人开始时间: 2011年4月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 266
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
- •Subjects will only be included in the study if they meet all of the following
- •· Patients male or female, aged 18 years or above,
- •· Patients with diagnosis of probable (1., 4., 5.) or definite (1., 2., 3., 5.) vestibular
- •migraine according to the criteria of Neuhauser (Neuhauser et al.
- •1. episodic vestibular symptoms of at least moderate severity (rotational
- •vertigo, other illusory self or object motion, positional vertigo, head motion
- •intolerance, i. e., sensation of imbalance or illusory self or object
- •motion that is provoked by head motion);
- •2. migraine according to the IHS criteria;
- •3. at least one of the following migrainous symptoms during at least two
- •vertiginous attacks: migrainous headache, photophobia, phonophobia,
- •visual or other auras;
- •4. at least one of the following: migraine according to the IHS criteria; migrainous
- •symptoms during vertigo as specified in 3.; migraine-specific
- •precipitants of vertigo, e. g. specific foods, sleep irregularities, hormonal
- •changes; response to antimigraine drugs
- •5. other causes ruled out by appropriate investigations;
- •· Between 6 and 30 attacks per 3 subsequent months;
- •· Subjects with the ability to follow study instructions and likely to attend and
- •complete all required visits;
- •· Written informed consent of the subject
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •Subjects will not be included in the study if any of the following criteria applies:
- •· Patients not able to give consent;
- •· Other vestibular disorders such as Menière´s disease, phobic postural vertigo, benign paroxysmal positioning
- •vertigo, vestibular paroxysmia;
- •· Central disorders such as paroxysmal brainstem attacks, TIAs;
- •· Contraindications for the treatment with metoprolol such as
- •o known allergic reaction to the trial drug or other beta receptor blockers;
- •o shock, acidosis
- •o Any bronchospastic disease, e.g. bronchial asthma;
- •o Sick sinus syndrome, known SA-block, AV-block;
- •o Bradycardia < 50 bpm at rest, systolic blood pressure < 100 mmHg, end-grade peripheral arterial
- •o Known severe coronary heart disease or heart failure;
- •o Concurrend treatment with MAO-inhibitors, sympathomimetic drugs, Catecholamine-depleting
- •drugs, digitalis glycosides;
- •· Poorly controlled diabetes mellitus;
- •· Pheochromocytoma;
- •· Suspicion of developing thyrotoxicosis;
- •· Disorders of hemostasis;
- •· Porphyria;
- •· Psoriasis;
- •· Pregnancy or breast-feeding;
- •· Persistent hypertension with systolic blood pressure > 180 mmHg or diastolic BP > 110 mmHg (mean
- •of 3 consecutive arm-cuff readings over 20-30 minutes) that cannot be controlled by antihypertensive
- •· Life expectancy < 12 months;
- •· Other serious illness, e.g., severe hepatic, cardiac, or renal failure, acute myocardial infarction, neoplasm
- •or a complex disease that may confound treatment assessment;
- •· Treatment with beta-blockers
- •· The patient has received any investigational medication within 30 days prior to administration of study
- •medication or is scheduled to receive an investigational drug up to 30 days after end of study;
- •· The patient was previously admitted to this trial or simultaneous participation in another clinical trial or
- •participation in any clinical trial involving an administration of investigational medicinal product.
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