Condition category
Signs and Symptoms
Date applied
05/10/2016
Date assigned
17/10/2016
Last edited
17/10/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Vertigo is when a person feels as if they or the objects around them are moving when they are not. It is a symptom of different diseases, mainly of the inner ear, sometimes of certain regions of the brain, that can have different underlying causes. Vertigo may appear continuously or in intervals, and other symptoms such as depression or anxiety can be also present. EGb 761®is a dry extract of Ginkgo biloba (maidenhair tree) which may be used for treatment of vertigo. Previously studies suggest that the effect of EGb 761® could be different depending on the cause, influence of risk factors, chronicity (duration of symptoms) and accompanying features. Therefore the aim of this study is to explore whether such factors influence the treatment effect of EGb 761®. This might be the basis to identify groups of patients that benefit most from EGb 761® treatment and help to improve treatment with EGb 761® in patients with vertigo.

Who can participate?
Adults aged at least 18 with a diagnosis of vertigo syndrome

What does the trial involve?
After a screening period (at most 14 consecutive days), all participants receive tablets containing EGb 761® for about 84 consecutive days (about 12 weeks). Participants take two tablets per day (one in the morning and one in the evening) regardless of meal times. Throughout the study side effects from the medication are monitored by the patient and care team. After 6 and 12 weeks, participants complete a number of questionnaires in order to find out if the medication has helped reduce their symptoms.

What are the possible benefits and risks of participating?
All participants receive EGb 761® treatment, which is expected to better control vertigo disease by reducing or eliminating its symptoms. Therefore, participants may benefit from an improvement in their quality of life. They may also benefit from detailed and extensive diagnostic tests. Blood tests may cause mild pain and can provoke bruises or tenderness in the extraction area. As part of the vertigo assessment, patients undergo several diagnostic examinations some of which can cause slight discomfort (e.g. applying warm water to the ear). As EGb 761® is well tolerated according to the data gathered so far, there is no major risk in taking EGb 761®. The adverse events potentially associated with EGb 761®, such as upset stomach, headache and allergic skin reactions, are usually mild in nature. Bleeding may also occur during treatment with EGb 761®.

Where is the study run from?
Centrum Medyczne LIMED (lead centre) and 11 other medical centres in Poland

When is the study starting and how long is it expected to run for?
December 2016 to May 2018

Who is funding the trial?
Dr Willmar Schwabe GmbH & Co. KG (Germany)

Who is the main contact?
1. Mrs Annette Wassmer (public)
2. Dr Robert Hoerr (scientific)

Trial website

Contact information

Type

Public

Primary contact

Mrs Annette Wassmer

ORCID ID

Contact details

Clinical Research Department
Dr Willmar Schwabe GmbH & Co KG
Willmar-Schwabe-Str. 4
Karlsruhe
76227
Germany

Type

Scientific

Additional contact

Dr Robert Hoerr

ORCID ID

http://orcid.org/0000-0002-9255-7679

Contact details

Clinical Research Department
Dr Willmar Schwabe GmbH & Co KG
Willmar-Schwabe-Str. 4
Karlsruhe
76227
Germany

Additional identifiers

EudraCT number

2016-000316-15

ClinicalTrials.gov number

Protocol/serial number

523079.01.114

Study information

Scientific title

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

Acronym

Study hypothesis

To explore the 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. As prior information whether different types of vertigo and effect modification by type of vertigo, chronicity and concomitant pathologies influence the treatment effect of EGb 761® is limited, no formal hypotheses are formulated and the data will be analyzed descriptively.

Ethics approval

Ethics Committee at Silesian Medical Chamber in Katowice, Grażyńskiego 49a, 40-126 Katowice, 15/06/2016, ref: 24/2016

Study design

Multicentre uncontrolled open-label explorative phase IIb clinical trial

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Vertigo

Intervention

The trial will involve 175 participants (male and female). The trial duration per participant is maximum of 15 weeks. Every patient receives 120 mg EGb 761® film coated tablets twice daily during the 12 treatment weeks. All patients undergo the following scheduled visits:

Screening visit: day -14 to day 0, medical history, vertigo diagnostic (ears-nose-throat examinations, audiometry, spontaneous nystagmus test with and without Frenzel glasses, Romberg test, Unterberger stepping test. Electronystagmography (ENG) or videonystagmography (VNG), caloric testing, video head impulse test (vHIT), vestibular evoked muscular potentials (VEMPs), Dix-Hallpike test, safety laboratory tests, electrocardiogram (ECG), vital signs, physical examination)
Baseline visit: Day 0, start treatment with EGb 761®, start treatment with EGb 761®, patient questionnaires (DHI, VSS, HADS, PSQ, SDS, TMT, severity of vertigo), concomitant medications, adverse events
Week 3 Call: Week 3 ± 1, concomitant medications, adverse events
Week 6 Visit: Week 6 ± 1 patient questionnaires, concomitant medications, adverse events
Week 9 Call: Week 9 ± 1, concomitant medications, adverse events
Week 12 Visit: Week 12 ± 1, vertigo diagnostic (ears-nose-throat examinations, audiometry, spontaneous nystagmus test with and without Frenzel glasses, Romberg test, Unterberger stepping test, patient questionnaires, concomitant medications, adverse events, safety laboratory tests, electrocardiogram (ECG), vital signs, physical examination).

Intervention type

Drug

Phase

Phase II

Drug names

EGb 761® (Ginkgo biloba extract)

Primary outcome measures

1. Effectiveness, measured using the Vertigo Symptom Scale – Short Form (VSS-SF) at baseline visit, Week 6 visit and Week 12 visit
2. Effectiveness, measured using the 11-point box scale for severity of vertigo at baseline visit, Week 6 visit and Week 12 visit
3. Effectiveness, measured using the Dizziness Handicap Inventory (DHI) at baseline visit, Week 6 visit and Week 12 visit
4. Anxiety and Depression, measured using the Hospital Anxiety and Depression Scale (HADS) at baseline visit, Week 6 visit and Week 12 visit
5. Stress, measured using the Perceived Stress Questionnaire (PSQ) at baseline visit, Week 6 visit and Week 12 visit
6. Cardiovascular disease, recorded by medical history at screening visit
7. Effectiveness, measured using the Sheehan Disability Scale (SDS) at baseline visit, week 6 visit and week 12 visit
8. Visual search, scanning, speed of processing, mental flexibility, measured using the Trail-Making Test (TMT) Forms A and B at baseline visit, Week 6 visit and Week 12 visit

Secondary outcome measures

1. Serious (SAEs) and non-serious adverse events (AEs), spontaneously reported by the patient or observed by the investigator continuously throughout the trial
2. Vital signs (blood pressure, pulse rate), measured in sitting position at baseline, 6 and 12 weeks
3. Safety laboratory results (hematology, coagulation, clinical chemistry and urinanalysis), measured via blood and urine samples at screening and 12 weeks

Overall trial start date

15/12/2015

Overall trial end date

31/05/2018

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

175

Participant 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 unable to read and/or write
20. Patients in custody by juridical or official order
21. Patients who are members of the staff of the trial center, staff of the sponsor or involved Clinical Research Organizations (CROs), the investigator him-/herself or close relatives of the investigator

Recruitment start date

15/11/2016

Recruitment end date

31/08/2017

Locations

Countries of recruitment

Poland

Trial participating centre

Centrum Medyczne LIMED
Tylna 12
Tarnowskie Góry
42-600
Poland

Trial participating centre

Grażyna Pulka Specjalistyczny Ośrodek "ALL-MED"
Św. Marka 31/1
Kraków
31-024
Poland

Trial participating centre

Medical Center Larmed
ul. Lwowska 17 lok. 1 and 2
Kraków
30-548
Poland

Trial participating centre

NUTRICARE Sp. z o.o.
Rydlówka 42 A/48
Kraków
30-363
Poland

Trial participating centre

Promed P.Łach R.Głowacki Spółka Jawna
ul. Entertainment 24a
Kraków
31-411
Poland

Trial participating centre

Centrum Medyczne Biotamed Morawska Barbara
ul. Vincent Fields 4a
Wieliczka
32-020
Poland

Sponsor information

Organisation

Dr Willmar Schwabe GmbH & Co. KG

Sponsor details

Willmar-Schwabe-Str. 4
Karlsruhe
76227
Germany

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Dr Willmar Schwabe GmbH & Co. KG

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing plan
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/05/2019

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes