Prophylactic treatment of vestibular migraine with metoprolol

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 260

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The number of vertigo attacks and number of migraine attacks during the last 3 months of the 6-month treatment period

Secondary Outcome Measures

Name	Time	Method
1. Number of vertigo attacks during the last 3 months of the total follow-up period of 9 months<br>2. Median duration and severity of vertigo attacks during the last 3 months of the 6-month treatment period and the last 3 months of the total follow-up period<br>3. Number of headache days per month during the last 3 months of the 6-month treatment period and the last 3 months of the total follow-up period<br>4. Change of peripheral vestibular function and handicap/impairment due to vertigo between baseline, 6-month visit and 9-month visit

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