Condition category
Nervous System Diseases
Date applied
07/07/2009
Date assigned
19/08/2009
Last edited
01/07/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://ifb.klinikum.uni-muenchen.de/de/Studienzentrum/PROVEMIG_Studie/index.html

Contact information

Type

Scientific

Primary contact

Prof Michael Strupp

ORCID ID

Contact details

Marchioninistr. 15
Munich
81377
Germany

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

Sponsor information

Organisation

Klinikum Grosshadern (Germany)

Sponsor details

Ludwig Maximilians University of Munich
Marchioninistr. 15
Munich
81377
Germany

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes

12/01/2016: the overall trial end date was changed from 31/12/2013 to 01/10/2019.