Plain English Summary
Not provided at time of registration
Trial website
http://ifb.klinikum.uni-muenchen.de/de/Studienzentrum/PROVEMIG_Studie/index.html
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
DRKS00005040; VMMET009
Study information
Scientific title
Prophylactic treatment of vestibular migraine with metoprolol: a double-blind, placebo-controlled trial
Acronym
PROVEMIG
Study hypothesis
Metoprolol (95 mg per day) is more effective in reducing the number of vertigo attacks and headache attacks in vestibular migraine than placebo.
Further details can be found at: http://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00005040 and http://ifb.klinikum.uni-muenchen.de/de/Studienzentrum/PROVEMIG_Studie/index.html
Ethics approval
Local Ethics Commitee of the Ludwig-Maximilians-University, pending as of 09/07/2009
Study design
Multicentre national randomised double-masked placebo-controlled two-arm parallel-group efficacy of treatment study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Vestibular migraine
Intervention
The trial comprises of two arms:
1. Therapy with metoprolol 95 mg per day
2. Placebo
The total treatment time will be six months with a three month follow-up. The trial is estimated to last four years (first patient in to last patient out).
Intervention type
Drug
Phase
Phase III
Drug names
Metoprolol
Primary outcome measures
The number of vertigo attacks and number of migraine attacks in the two treatment groups during the last 3 months of the 6-month treatment period.
Secondary outcome measures
1. Number of vertigo attacks during the last 3 months of the total follow-up period of 9 months
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
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
4. Change of peripheral vestibular function and handicap/impairment due to vertigo between baseline, 6-month visit and 9-month visit
Overall trial start date
01/01/2010
Overall trial end date
01/10/2019
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
260
Participant 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 breast-feeding
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
Recruitment start date
01/01/2010
Recruitment end date
01/07/2018
Locations
Countries of recruitment
Germany
Trial participating centre
University Medical Center München
-
Germany
Trial participating centre
Medical Center Celle
-
Germany
Trial participating centre
Medical Center Altötting
-
Germany
Trial participating centre
University Medical Center Tübingen
-
Germany
Trial participating centre
University Medical Center Essen
-
Germany
Trial participating centre
Medical Center Parkklinik Weißensee, Berlin
-
Germany
Funders
Funder type
Government
Funder name
Bundesministerium für Bildung und Forschung - Integrated Research and Treatment Centre (IFB)
Alternative name(s)
Federal Ministry of Education and Research, BMBF
Funding Body Type
government organisation
Funding Body Subtype
federal
Location
Germany
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary