DRKS00005040进行中（未招募）3 期
Prophylactic treatment of vestibular migraine with metoprolol: a double-blind, placebo-controlled trial - PROVEMIG
Klinikum der Universität München, Campus Großhadern0 个研究点目标入组 130 人开始时间: 2013年8月22日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 130
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •· 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
排除标准
- •· 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
- •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 disease;
- •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 therapy;
- •· 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;
研究者
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