ISRCTN72824329已完成3 期
Prophylactic treatment of vestibular migraine with metoprolol: a double-blind, placebo-controlled trial
Klinikum Grosshadern (Germany)0 个研究点目标入组 260 人开始时间: 2009年8月19日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 260
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Diagnosis of definite vestibular migraine according to the criteria of Neuhauser et al. 2001:
- •1.1. 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)
- •1.2. Migraine according to the International Headache Society (IHS) criteria
- •1.3. At least one of the following migrainous symptoms during at least two vertiginous attacks: migrainous headache, photophobia, phonophobia, visual or other auras
- •1.4. Other causes ruled out by appropriate investigations
- •2. At least two attacks per month for at least 3 subsequent months
- •3. Aged 18 to 80 years, either sex
- •4. Written informed consent, signed and dated by the patient (or patient's authorised representative) and by the person obtaining the consent, indicating agreement to comply with all protocol-specified procedures
排除标准
- •1. Other vestibular disorders such as Meniere's disease, phobic postural vertigo, benign paroxysmal positioning vertigo, vestibular paroxysmia; central disorders such as paroxysmal brainstem attacks, transient ischaemic attacks (TIAs)
- •2. Contraindications for the treatment with metoprolol such as:
- •2.1. Known allergic reaction to one of the trial drugs
- •2.2. Pregnancy or breastfeeding
- •2.3. Sinoatrial (SA)-block, atrioventricular (AV)-block, sick sinus syndrome, bradycardia less than 50 bpm at rest, systolic blood pressure less than 100 mmHg, end-grade peripheral arterial disease, and bronchial asthma
- •2.4. Pheochromocytoma
- •2.5. Poorly controlled diabetes mellitus
- •2.6. Porphyria
- •2.7. Psoriasis
- •2.8. Disorders of haemostasis
- •2.9. Concurrent medications, such as monoamine oxidase (MAO)-inhibitor, sympathomimetic drugs
- •2.10. Known severe coronary heart disease or heart failure
- •2.11. Persistant hypertension with systolic blood pressure greater than 180 mmHg or diastolic BP greater than 110 mmHg (mean of three consecutive arm-cuff readings over 20 - 30 minutes) that cannot be controlled by anti-hypertensive therapy
- •2.12. Life expectancy less than 12 months
- •3. Other serious illness, e.g., severe hepatic, cardiac, or renal failure, acute myocardial infarction, neoplasm or a complex disease that may confound treatment assessment
- •4. Participation in another study with an investigational drug or device within the last 30 days, prior participation in the current study, or planned participation in another trial
研究者
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