Multi-center, prospective, controlled, randomized, single-blinded study to evaluate the efficacy of vibrotactile neuro-feedback additionally to intake of Ginkgo biloba special extract EGb 761® for the treament of presby vertigo.

Phase 1

• Conditions: Presby Vertigo; MedDRA version: 20.0 Level: PT Classification code 10047340 Term: Vertigo System Organ Class: 10013993 - Ear and labyrinth disorders; Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

• Registration Number: EUCTR2014-000303-28-DE
• Lead Sponsor: Dr. Willmar Schwabe GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-08-07
• Study Completion: 2018-06-19
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 120

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Tendency to falling in stance and gait conditions;<br> Secondary Objective: - subjective impairment due to vertigo<br> - hearing ability<br> - cognitive capacity<br> -safety and tolerability<br> ;Primary end point(s): Change of tendency of falling ;Timepoint(s) of evaluation of this end point: after 6 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): - Change of tendency of falling between V2 and V3 as well as V2 and V5<br> - subjective restrictions due to vertigo<br> - hearing ability<br> - cognitive capacity<br> -safety and tolerability<br> ;<br> Timepoint(s) of evaluation of this end point: - After 4 weeks of treatment with EGb761® (Visite 3)<br> - After 6 weeks treatment (4 weeks only EGb761®, 2 weeks EGb761® and balance exercise) (Visite 4)<br> - 6 weeks after end of balance training (12 weeks EGb761® inclusive 2 weeks balance exercise) (Visite 5).<br>