Prophylactic treatment of vestibular migraine with metoprolol: a double-blind, placebo-controlled trial

Phase 3

• Conditions: G43; H81.4; H81.9; R42; Migraine; Vertigo of central origin; Disorder of vestibular function, unspecified; Dizziness and giddiness

• Registration Number: DRKS00005040
• Lead Sponsor: Klinikum der Universität München, Campus Großhadern

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-22
• Study Completion: 2018-01-03
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

· 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.
2001):
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

Exclusion Criteria

· 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 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;

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The number of vertigo attacks and the number of headache attacks<br>during the last 3 months of the total follow-up period of 9 months;<br><br>the median duration and severity of vertigo attacks during the last 3<br>months of the 6-month treatment period and the last 3 months of the<br>total follow-up period;<br><br>the number of headache days per month during the last 3 months of<br>the 6-month treatment period and the last 3 months of the total follow-<br>up period;<br><br>the changes in the neurological and neuro-orthoptic examination and<br>handicap / impairment due to vertigo between baseline, 6-month visit<br>and 9-month visit.