Presby Vertigo MedDRA version: 20.0 Level: PT Classification code 10047340 Term: Vertigo System Organ Class: 10013993 - Ear and labyrinth disorders
Conditions
Interventions
Trade Name: Tebonin® spezial 80 mg
Product Name: EGb 761
Product Code: EGb 761
Pharmaceutical Form: Film-coated tablet
CAS Number: 12293
Sponsors
Dr. Willmar Schwabe GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women aged 60 or older 2. subjective chronic vertigo for > 3 months 3. Dizziness Handicap Inventory (DHI) score > 25 4. Geriatrischen Standard Balance Defizit Test determined risk of falling > 40 % 5. Written informed consent 6. Willingness and ability to participate all stuy specific tasks Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: 1. hemorrhagic diatheses, coagulation disorder, Ulcus ventriculi or duodeni 2. Diseases affecting resorption 3. Severe or acute general diseases within the last 4 weeks 4. Acute or chronic otologic, neurologic or psychiatric diseases within the last 12 months except age-related vertigo, i.e. depression, stroke, TIA, Parkinson-disease, Alzheimer-disease, seizure disorders, craniocerebral trauma, brain haemorrhage, Multiple sklerosis, ISSHL, morbus menière, benign positional vertigo 5. Severe or instable internal disorders such as a. Malignoma with the exception of carcinoma in situ, adequately treated basal cell carcinoma or curative treated malignom more than 3 years ago b. uncontrolled arterial hypertension c. uncontrolled Diabetes mellitus d. Known cardiac arrhythmia (Lown-classification IVb and V) e. Heart failure NYHA III or IV f. Active bacterial infections g. Severe coronary heart disease (State IV Canadian Cardiovascular Society), instable angina pectoris, heart attack within the last 6 months 6. clinically significant changes ECG- or Lab, that need treatment 7. Hypersensitivity against one of the ingredients of the study drug 8. Substance misuse or addiction current or in medical history 9. Participation in other clinical trials within the last 12 weeks 10. Concomitant medication out of one of the following substance classes a. anticoagulants (Heparin, Vitamin-K-Antagonist, Dabigatran, Apixaban or Rivaroxaban) b. Antidementics or Nootropics c. benzodiazepines 11. Intake of a Ginkgo-biloba products within the last 12 weeks 12. Planned surgery or hospitalization during study period 13. Other factors that prevent from study participation 14. People, who are in institutional care due to official or ancillary order 15. People, who depend on sponsor or investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Tendency to falling in stance and gait conditions; Secondary Objective: - subjective impairment due to vertigo - hearing ability - cognitive capacity -safety and tolerability ;Primary end point(s): Change of tendency of falling ;Timepoint(s) of evaluation of this end point: after 6 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Change of tendency of falling between V2 and V3 as well as V2 and V5 - subjective restrictions due to vertigo - hearing ability - cognitive capacity -safety and tolerability ; Timepoint(s) of evaluation of this end point: - After 4 weeks of treatment with EGb761® (Visite 3) - After 6 weeks treatment (4 weeks only EGb761®, 2 weeks EGb761® and balance exercise) (Visite 4) - 6 weeks after end of balance training (12 weeks EGb761® inclusive 2 weeks balance exercise) (Visite 5). | — |
Countries
Germany
Contacts
Public ContactMedical Affairs
Dr. Willmar Schwabe GmbH & Co. KG
Outcome results
None listed