Study to demonstrate the clinical efficacy and effects on brain electrical activity of the special Ginkgo extract EGb 761 in patients suffering from dizziness with disturbance of balance and eye movements after attacks of reduced perfusion in the rear areas of the brai

Phase 4

Completed

• Conditions: Vertigo due to vertebrobasilar ischemic events; Nervous System Diseases

• Registration Number: ISRCTN14486389
• Lead Sponsor: Dr Willmar Schwabe (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 1994-04-28
• Study Start: 2020-10-27
• Last Update Posted: 9 November 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified