Vertigo due to vertebrobasilar ischemic events Nervous System Diseases
Conditions
Interventions
Treatments (EGb 761® or placebo) were assigned to patient numbers by a computer program. EGb 761® and placebo capsules were indistinguishable by appearance, packed and labelled with patient numbers in
Sponsors
Dr Willmar Schwabe (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent in accordance with applicable laws 2. Age at least 30 years, no older than 75 years 3. Patients who had experienced an ischemic event (transient or insult type) in the vertebrobasilar supply area. Unambiguous localization of the ischemia based on clinical symptoms or computed tomography or magnetic resonance tomography 4. Vertigo and/or imbalance still present permanently or in form of recurrent attacks 5. Vertigo score (derived from frequency, duration an severity) at least 5 6. Additional criterion for patients to be diagnosed with cognitive impairment: abnormally low performance in at least one of three cognitive tests (Short Test of General Intelligence, KAI, at least 10% loss; Auditory Verbal Learning Test, AVLT, less than 8 points in the 5th cycle; Mosaic Test, less than 15 raw points
Exclusion criteria
Exclusion criteria: 1. Participation in another experimental drug trial at the same time or within the past 4 weeks before the baseline visit 2. Pregnancy or breastfeeding 3. Age below 30 years 4. Peripheral vestibular vertigo, as assessed by the caloric labyrinth test (if the difference of maximal velocity of slow nystagmus phases is more than 25% of the sum of the means under cold and hot stimuli) or head-shaking nystagmus (if provokable) or vestibulo-ocular reflex, VOR (if gain at high-frequency stimulation (e.g. Halmagy test) not bilaterally normal) 5. Vertigo/dizziness of cardio-vascular origin (clinical signs of decompensated cardiac failure or signs of recurrent periods of tachycardia or bradycardia in EEG which are supposed to affect hemodynamics) 6. Dementia or severe organic brain syndrome which would render the vertigo-related medical history as provided by the patient unreliable 7. Brainstem or cerebellar lesions of a non-vascular origin or impaired brain function due to non-vascular (e.g. metabolic, toxic, inflammatory) causes or intracranial mass 8. Severe vision disorder (visual acuity less than 0.5 on both eyes) 9. Oculomotor dysfunction due to a disorder not covered by the inclusion criteria 10. Chronic alcohol abuse or alcohol dependency 11. Severe cardio-circulatory failure, severe liver or renal failure, severe respiratory failure, advanced neoplasia 12. Gait impairment due to Parkinson syndrome 13. Severe hemiparesis or aphasia 14. Spinal lesion or severe polyneuropathy with impairment of deep sensibility (vibration sensibility at the knees less than 3/8) 15. Continued treatment with rheologically active or perfusion-enhancing drugs, phenytoin, carbamazepine, neuroleptics, benzodiazepines, nootropics, or ant-vertigo agents (e.g. dimenhydrinate, metoclopramide, scopolamine, cinnarizine, flunarizine, diphenhydramine, alizapride, betahistine) 16. Hypersensitivity to Ginkgo biloba extracts
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Improvement of vertigo, assessed by the difference in changes in patient’s global impression of vertigo severity (0-100 analogue scale) from Day 0 visit to Day 120 visit 2. Improvement of vertigo, assessed by the difference at Day 120 visit in the physician’s global impression of change in vertigo severity | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Improvement of vertigo, assessed by the difference in changes in patient’s global impression of vertigo severity (0-100 analogue scale) from Day 0 to Day 60 and from Day 0 to Day 180 2. Improvement of vertigo, assessed by the differences in the physician’s global impression of change in vertigo severity at Day 60 and Day 180 3. Improvement of vertigo, assessed by the difference in changes in the vertigo score, which is derived from frequency, duration and severity of vertigo, from Day 0 to Day 60, Day 120 and Day 180, respectively 4. Improvement of balance, assessed by the difference in changes in the lateral sway amplitude in posturography from Day 0 to Day 60, Day 120 and Day 180, respectively 5. Improvement in oculomotor disturbances, assessed by the difference in changes in oculomotor test parameters from Day 0 to Day 120 and Day 180, respectively 6. Improvement in cognition, assessed by the difference in changes in neuropsychological test scores (only in patients who had abnormal scores at baseline) from Day 0 to Day 120 7. Serious (SAEs) and non-serious adverse events (AEs), spontaneously reported by the patient or observed by the investigator continuously throughout the trial 8. Safety laboratory results (hematology, clinical chemistry) measured via blood samples at screening and Day 180 | — |
Countries
Germany
Outcome results
None listed