Trial document




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  DRKS00005040

Trial Description

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Title

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

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Trial Acronym

PROVEMIG

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URL of the Trial

http://www.klinikum.uni-muenchen.de/Deutsches-Schwindelzentrum-IFB-LMU/de/Studienzentrum/PROVEMIG_Studie/index.html

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Brief Summary in Lay Language

To date there is no prophylactic drug for vestibular migraine shown to be effective in controlled clinical trials. This study investigates, whether there is a prophylactic effect of Metoprolol on attacks in patients with vestibular migraine.

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Brief Summary in Scientific Language

Primary Objective :
To demonstrate the superiority of Metoprolol Succinate treatment regarding the
number of vertigo attacks and the number of headache attacks per month compared
to placebo.
Secondary Objective:
To analyze whether the superiority of Metoprolol Succinate treatment is kept up
to three months after the last drug intake. To quantitatively describe and compare
the median duration and severity of vertigo attacks, the number of headache days, neurological and neuro-orthoptic examination and the change of
handicap / impairment due to vertigo or dizziness vs. placebo. To check for the
occurrence of the adverse effects reported in the summary of the medical
product characteristics (SmPC) of the drug.

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Organizational Data

  •   DRKS00005040
  •   2013/08/22
  •   2011/04/08
  •   yes
  •   Approved
  •   152-11, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

  •   2009-013701-34 
  •   EUCTR2009-013701-34-DE  (EU Clinical Trials Register)
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Health Condition or Problem studied

  •   G43 -  Migraine
  •   H81.4 -  Vertigo of central origin
  •   H81.9 -  Disorder of vestibular function, unspecified
  •   R42 -  Dizziness and giddiness
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Interventions/Observational Groups

  •   metoprolol succinate (BelocZok(R)) 95 mg once a day orally for 6 months
  •   placebo
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, assessor
  •   Placebo
  •   Treatment
  •   Parallel
  •   III
  •   Yes
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Primary Outcome

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

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Secondary Outcome

The number of vertigo attacks and the number of headache attacks
during the last 3 months of the total follow-up period of 9 months;

the 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;

the 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;

the changes in the neurological and neuro-orthoptic examination and
handicap / impairment due to vertigo between baseline, 6-month visit
and 9-month visit.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/06/20
  •   266
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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

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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;

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Addresses

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    • Klinikum der Universität München, Campus Großhadern
    • Marchioninistraße 15
    • 81377  München
    • Germany
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    • Klinikum der Universität München, Campus Großhadern Deutsches Schwindel- und Gleichgewichtszentrum (IFB) Studienzentrale
    • Mr.  Privdoz. Dr. med., MPH  Otmar  Bayer 
    • Marchioninistr. 15
    • 81377  München
    • Germany
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    • Klinikum der Universität München, Campus Großhadern Deutsches Schwindel- und Gleichgewichtszentrum (IFB) Studienzentrale
    • Marchioninistr. 15
    • 81377  München
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Bonn
    • Heinemannstr. 2
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting stopped after recruiting started
  •   2018/01/03
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Trial Publications, Results and other Documents

  • [---]*
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* This entry means the parameter is not applicable or has not been set.