Clinical Trials Register

Summary
EudraCT Number:	2016-000316-15
Sponsor's Protocol Code Number:	523079.01.114
National Competent Authority:	Poland - Office for Medicinal Products
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2016-07-20
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Poland - Office for Medicinal Products

A.2

EudraCT number

2016-000316-15

A.3

Full title of the trial

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

Badanie kliniczne skuteczności leczenia wyciągiem z miłorzębu japońskiego EGb 761® u pacjentów z różnymi typami zawrotów głowy, a także zmiany tej skuteczności w zależności od typu i przewlekłości zawrotów głowy oraz zaburzeń współtowarzyszących.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A.4.1

Sponsor's protocol code number

523079.01.114

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Dr. Willmar Schwabe GmbH & Co. KG
B.1.3.4	Country	Germany
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Dr. Willmar Schwabe GmbH & Co. KG
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Dr. Willmar Schwabe GmbH & Co. KG
B.5.2	Functional name of contact point	Project Director
B.5.3	Address:
B.5.3.1	Street Address	Willmar-Schwabe-Str. 4
B.5.3.2	Town/ city	Karlsruhe
B.5.3.3	Post code	76227
B.5.3.4	Country	Germany
B.5.4	Telephone number	00497214005632
B.5.5	Fax number	004972140058632632
B.5.6	E-mail	Annette.Wassmer@schwabe.de

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Tebonin ® intens 120 mg
D.2.1.1.2	Name of the Marketing Authorisation holder	Dr. Willmar Schwabe GmbH & Co. KG
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	EGb 761®
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Ginkgo biloba special extract EGb 761®
D.3.9.3	Other descriptive name	Dry extract from Ginkgo biloba leaves (35-67:1) 120 mg; extraction agent: acetone 60% (w/w)
D.3.9.4	EV Substance Code	SUB47670
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	120
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	Yes
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	Yes
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Different types of vertigo

Różne rodzaje zawrotów głowy

E.1.1.1

Medical condition in easily understood language

Different types of vertigo

Różne rodzaje zawrotów głowy

E.1.1.2

Therapeutic area

Diseases [C] - Ear, nose and throat diseases [C09]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10047340
E.1.2	Term	Vertigo
E.1.2	System Organ Class	10013993 - Ear and labyrinth disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

• To explore whether causes, risk factors, chronicity of vertigo and accompanying features influence the treatment effect of EGb 761® in terms of improvement and response rates
• To identify groups of patients that benefit most of EGb 761®

E.2.2

Secondary objectives of the trial

Not applicable

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Inclusion criteria
1. Outpatients of both sexes, at least 18 years old.
2. Vertigo syndrome
a. diagnosed and specified by medical history and physical examination, Rombergtest, Unterberger stepping test, nystagmus testing with (alternatively by VNG) andwithout Frenzel glasses, and the following diagnostic tests which may have beenperformed 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 BPPV), ECG;
b. 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;
c. 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.
Note: The gaze test and positional test may alternatively be performed with Frenzelglasses instead of ENG / VNG.

E.4

Principal 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
a. severe (Canadian Cardiovascular Society stage IV) or unstable angina pectoris
b. decompensated congestive heart failure (NYHA stage IV)
c. uncontrolled hypertension with systolic blood pressure above 180 mmHg and/or diastolic blood pressure above 115 mmHg
d. 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.

E.5 End points

E.5.1

Primary end point(s)

Effectiveness:
• Vertigo Symptom Scale – Short Form (VSS-SF, Yardley et al. 1992, 2004)
• 11-point box scale for severity of vertigo
• Dizziness Handicap Inventory (DHI, Jacobson & Newman 1990)

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 6 Visit and Week 12 Visit.

All analyses will be done at the end of the trial.

E.5.2

Secondary end point(s)

Safety:
• Serious adverse events (SAEs) and non-serious adverse events
• Vital signs
• Safety laboratory results

E.5.2.1

Timepoint(s) of evaluation of this end point

Serious adverse events (SAEs) and non-serious adverse events throughout the whole trial.
Vital signs and safety laboratory results at Screening Visit and Week 12 Visit.

All analyses will be done at the end of the trial.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

to explore whether causes, risk factors, chronicity of vertigo and accompanying features influence the treatment effect of EGb 761®

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

Data base lock

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

140

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

175

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

After the study has ended the participation in the trial the subject will be receiving the standard therapy according to the clinical practice in Poland.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2016-09-17

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-06-15

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2018-06-12

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials