Prophylactic treatment of vertigo attacks as migrainous symptoms

Phase 1

• Conditions: vestibular migraine; MedDRA version: 20.0 Level: PT Classification code 10027599 Term: Migraine System Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2009-013701-34-DE
• Lead Sponsor: Hospital of the University of Munich

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-04-08
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 266

Inclusion Criteria

Subjects will only be included in the study if they meet all of the following
criteria:
· 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.
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
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

Exclusion Criteria

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
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;
· 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified