vestibular migraine MedDRA version: 20.0 Level: PT Classification code 10027599 Term: Migraine System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Beloc-Zok
Pharmaceutical Form: Tablet
INN or Proposed INN: METOPROLOL SUCCINATE
CAS Number: 98418-47-4
Concentration unit: m
Sponsors
Hospital of the University of Munich
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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: 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. ; Primary end point(s): Primary Endpoint: • The number of vertigo attacks and the number of headache attacks during the last 3 months of the 6-month treatment period. ;Timepoint(s) of evaluation of this end point: During the last 3 month of the 6-month treatment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Endpoints: • 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. ; Timepoint(s) of evaluation of this end point: - During the last 3 months of total follow-up period of 9 month; - During the last 3 months of 6-months treatment period; - During the last 3 months of 6-months treatment and the last 3 months of total follow-up period of 9 month; | — |
Countries
Germany
Contacts
Public ContactDSGZ
Hospital of the University of Munich
Outcome results
None listed