Clinical trial to explore treatment effects of Ginkgo biloba Extract EGb 761® in patients with different types of vertigo and effect modification by type of vertigo, chronicity and concomitant pathologies

Phase 2

Completed

• Conditions: Vertigo; Signs and Symptoms

• Registration Number: ISRCTN83227991
• 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: 2016-10-17
• Study Completion: 2018-06-12
• Last Update Posted: 12 September 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 206

Inclusion Criteria

1. Outpatients of both sexes, at least 18 years old
2. Vertigo syndrome:
2.1. Diagnosed and specified by medical history and physical examination, Romberg test, Unterberger stepping test, nystagmus testing with and without Frenzel glasses, and the following diagnostic tests which may have been performed up to 3 months before Baseline Visit: ENG or VNG including caloric testing, vHIT, VEMPs, Dix-Hallpike test (only to be performed if necessary to exclude benign paraoxysmal positional vertigo (BPPV)), ECG
2.2. Excluding BPPV, Ménière's disease, vestibular migraine, somatoform phobic vertigo, acute vestibular neuritis within the first two weeks of onset, acute central or peripheral vertigo within the first two weeks of onset
2.3. Duration of at least 2 weeks
3. Score > 25 in the Dizziness Handicap Inventory
4. Written informed consent to participate in the clinical trial, to trial-related treatment and to data recording in accordance with applicable laws

Exclusion Criteria

1. Participation in another experimental drug trial at the same time or within the past 4 weeks before Baseline Visit
2. Vertigo for which other treatments are recommended by current guidelines or expert consensus: BPPV, Ménière's disease, vestibular migraine, somatoform phobic vertigo, acute vestibular neuritis within the first two weeks of onset, acute central or peripheral vertigo within the first two weeks of onset
3. Any other drug treatments for vertigo taken currently or within 2 weeks before Baseline Visit
4. Gingko biloba preparation for any reason taken currently or within 4 weeks before Baseline Visit
5. Ongoing psychiatric disorder, such as major depression, generalized anxiety disorder, schizophrenia, etc. Of note: Symptoms of depression or anxiety or other behavioral or psychological symptoms at sub-syndromal level and not requiring treatment with psychotropic drugs are permitted
6. Ongoing severe cardiac or circulatory disorder:
6.1. Severe (Canadian Cardiovascular Society stage IV) or unstable angina pectoris
6.2. Decompensated congestive heart failure (NYHA stage IV)
6.3. Uncontrolled hypertension with systolic blood pressure above 180 mmHg and/or diastolic blood pressure above 115 mmHg
6.4. Clinically significant cardiac arrhythmias (Lown classes IVb and V, bifascicular bundle branch block)
7. Severe renal or hepatic dysfunction (defined by serum creatinine or serum ASAT, ALAT or gamma-GT above 3 times the upper limit of the reference range in the anamnesis)
8. Ongoing uncontrolled endocrine or hematological disorder
9. Intake of drugs not permitted during participation in the trial, in particular, psychoactive drugs, systemic acting perfusion-enhancing drugs, cognition enhancing drugs, systemic acting anti-cholinergic drugs, regular use of anticoagulants (platelet aggregation inhibitors permitted) during the 2 weeks prior to Baseline Visit
10. Ongoing hemorrhagic diathesis or coagulation disorder
11. Seizure within 2 years prior to Baseline Visit or regular use anticonvulsive drugs
12. Active malignant disease (exception: prostate cancer which does not require other than hormone treatment within the next 6 months).
13. Known hypersensitivity to Ginkgo biloba extract or to excipients contained in the tablets
14. Active peptic ulcer disease or any gastrointestinal disease with potential impairment of the absorption of orally applied drugs (e.g. Billroth I/II, Crohn's disease, ulcerative colitis, any kind of enterectomy)
15. Female patients of childbearing potential without safe contraception (any form of hormonal contraception, intrauterine devices, sexual abstinence and partner sterilization are considered sufficiently safe when used consistently and correctly; child-bearing potential can be denied in case of postmenopausal state for at least 2 years, hysterectomy, bilateral tubal ligation or bilateral oophorectomy).
16. Planned surgical intervention requiring hospitalization during the clinical trial
17. Previous inclusion in the present clinical trial
18. Incapability of understanding nature, meaning and consequences of the clinical trial
19. Patient unab

Study & Design

• Study Type: Interventional
• Study Design: Not specified