Clinical Trials Register

Summary
EudraCT Number:	2015-003395-72
Sponsor's Protocol Code Number:	VitD@BPPV
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2016-07-21
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

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A. Protocol Information

A.1

Member State Concerned

Germany - BfArM

A.2

EudraCT number

2015-003395-72

A.3

Full title of the trial

Vitamin D in secondary prevention of benign paroxysmal positional vertigo: a prospective, multicenter, randomized, placebo-controlled, double-blind study (VitD@BPPV)

Sekundärprophylaxe des benignen peripheren paroxysmalen Lagerungsschwindels mit Vitamin D: eine prospektive randomisierte Placebo-kontrollierte doppelblinde multizentrische Studie

A.3.1

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

Vitamin D in secondary prevention of BPPV

Vitamin D zur Sekundärprophylaxe des BPPV

A.3.2

Name or abbreviated title of the trial where available

Vitamin D in secondary prevention of BPPV

Vitamin D zur Sekundärprophylaxe des BPPV

A.4.1

Sponsor's protocol code number

VitD@BPPV

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	Hospital of the University of Munich
B.1.3.4	Country	Germany
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Bundesministerium für Bildung und Forschung
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	Hospital of the University of Munich
B.5.2	Functional name of contact point	DSGZ Studienzentrale
B.5.3	Address:
B.5.3.1	Street Address	Marchioninistrasse 15
B.5.3.2	Town/ city	Munich
B.5.3.3	Post code	81377
B.5.3.4	Country	Germany
B.5.4	Telephone number	0049089440076987
B.5.5	Fax number	0049089440078795
B.5.6	E-mail	ivonne.naumann@med.uni-muenchen.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	Dekristol 1000 I.E.
D.2.1.1.2	Name of the Marketing Authorisation holder	MIBE Arzneimittel GmbH
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.3.4	Pharmaceutical form	Capsule, hard
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	CHOLECALCIFEROL
D.3.9.1	CAS number	67-97-0
D.3.9.3	Other descriptive name	CHOLECALCIFEROL CONCENTRATE (POWDER FORM)
D.3.9.4	EV Substance Code	SUB37745
D.3.10	Strength
D.3.10.1	Concentration unit	IU international unit(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1000
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	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	No
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	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule, hard
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

The main symptoms of Benign Paroxysmal Positional Vertigo (BPPV) are brief, in part strong attacks of rotatory vertigo lasting seconds. These attacks can be provoked by reclination of the head or turning of the head/the body toward the affected ear. The pathophysiology of BPPV is related to a displacement of the otoconia toward the semicircular canals, which may remain floating in the endolymph of the semicircular canal (canalolithiasis) or adhere to the cupula (cupulithiasis).

Patienten mit benignem peripheren paroxysmalen Lagerungsschwindel (BPPV) leiden an Sekunden dauernden, zum Teil starken Drehschwindelattacken, die durch Kopfreklination oder Kopf- bzw. Körperseitlagerung zum betroffenen Ohr ausgelöst werden. Pathophysiologisch beruht der BPPV auf eine Ablösung von Otokonien in die Bogengänge, wo sie in der Endolymphe der Bogengänge treiben (Canalolithiasis) oder an die Cupula adhärieren (Cupulolithiasis) können.

E.1.1.1

Medical condition in easily understood language

The main symptoms of BPPV are brief, in part strong attacks of rotatory vertigo lasting seconds. These attacks can be provoked by movements of the head and/or of the body.

Patienten mit BPPV leiden an Sekunden dauernden, zum Teil starken Drehschwindelattacken, die durch Kopf- und/oder Körperbewegungen ausgelöst werden.

E.1.1.2

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Proof of efficacy of vitamin D to the reduction of the number of patients with one or more relapses of BPPV

Nachweis der Wirksamkeit von Vitamin D auf die Reduktion der Zahl von Patienten mit einem oder mehreren Rezidiven des BPPVs

E.2.2

Secondary objectives of the trial

- Quantification of the limitation due to vertigo (investigation by means of „Dizziness Handicap Inventory“ (DHI) and „Vestibular Disorders Activities of Daily Living Scale“ (VDADL)
- Proof of efficacy of vitamin D to the reduction of frequency of relapses of every single patient
- Group analysis: vitamin D
1) within reference range at timepoint of study inclusion and treatment within placebo group
2) below reference range at time point of study inclusion and treatment within placebo group
3) within reference range at time point of study inclusion and treatment within verum group
4) below reference range at time point of study inclusion and treatment within verum group

•Quantifizierung der Einschränkung aufgrund des Schwindels (Erhebung mittels „Dizziness Handicap Inventory“ (DHI) und „Vestibular Disorders Activities of Daily Living Scale“ (VDADL)
•Nachweis der Wirksamkeit von Vitamin D auf die Reduktion der Rezidivhäufigkeit bei jedem einzelnen Patienten
•Gruppenanalyse nach
1.Vitamin D innerhalb des Referenzbereiches bei Stu-dieneinschluss und Behandlung innerhalb der
Placebogruppe im Rahmen der Studie
2.Vitamin D unterhalb des Referenzbereiches bei Stu-dieneinschluss und Behandlung innerhalb der
Placebogruppe im Rahmen der Studie
3.Vitamin D innerhalb des Referenzbereiches bei Stu-dieneinschluss und Behandlung innerhalb der
Verumgruppe im Rahmen der Studie
4.Vitamin D unterhalb des Referenzbereiches bei Stu-dieneinschluss und Behandlung innerhalb der
Verumgruppe im Rahmen der Studie

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Written informed consent to participation in the study
- Age ≥ 18 years
- Patients with BPPV of the posterior, horizontal or anterior semicircular canal (confirmed by diagnostic maneuvers) of different etiologies (idiopathic, traumatic, other vestibular diseases)
- The ability to follow study instructions and likely to attend and complete all visit

- Schriftlich dokumentierte Einwilligung zur Teilnahme an der Studie
- Alter ≥ 18 Jahre
- Patienten mit einem BPPV des posterioren, horizontalen oder anterioren Bogengangs (bestätigt durch diagnostische Lagerungsmanöver) verschiedener Ätiologien (idiopathisch, traumatisch, andere vestibuläre Erkrankungen)
- Patienten, die in der Lage sind, die Studienanweisungen zu befolgen und die wahrscheinlich alle erforderlichen Studienvisiten einhalten werden

E.4

Principal exclusion criteria

- Osteoporosis
- Hyper-/Hypocalcemia
- Hyper-/Hypophosphatemia
- Hypercalcuria
- Uro-/Nephrolithiasis in medical history
- Intake of vitamin D-metabolites/-analogues
- Intake of cardiac glycosides
- Sarkoidosis
- Active or intended pregnancy
- Hereditary fructose intolerance, glucose-galactose malabsorption, sucrase-isomaltase deficiency, congenital galactose intolerance, congenital lactase deficiency
- Pseudohypoparathyreodism
- Life threatening disease with statistical life expectancy < 12 months
- Former participation in this study or participation in a clinical trial with intake of an investigational drug within the last 30 days before participation in this study

- Osteoporose
- Hyper-/Hypocalciämie
- Hyper-/Hypophosphatämie
- Hyperkalcurie
- Uro-/nephrolithiasis in der Anamnese
- Einnahme von Vitamin D-Metaboliten/-Analoga
- Einnahme von Herzglycosiden
- Sarkoidose
- Bestehende oder geplante Schwangerschaft
- Hereditäre Fruktose-Intoleranz, Glucose-Galaktose-Malabsorption, Saccharose-Isomaltase-Mangel, hereditäre Ga-laktose-Intoleranz, kongenitaler Lactase-Mangel
- Pseudohypoparathyreodismus
- Lebensbedrohliche Erkrankung mit statistischer Lebenserwartung < 12 Monaten
- Vorherige Teilnahme an dieser Studie oder Teilnahme an einer klinischen Prüfung mit Einnahme einer Prüfmedikation bis zu 30 Tage vor Teilnahme an dieser klinischen Prüfung

E.5 End points

E.5.1

Primary end point(s)

Number of patients with relapse(s) of BPPV between visit 2 and final visit (corresponding observation period of 12 months)

Anzahl der Patienten mit Rezidiv/Rezidiven des BPPVs zwischen Visite 2 und der Abschlussvisite (entsprechend einem Beobachtungszeitraum von 12 Monaten)

E.5.1.1

Timepoint(s) of evaluation of this end point

- At the end of the study

- Am Ende der Studie

E.5.2

Secondary end point(s)

- Absolute change of DHI and VDADL measured before (V1), 2 months (V2) and 7 months (V3) after beginning of the therapy and at the end of the treatment period (14 months after beginning of therapy, V4); DHI and VDADL will also be measured at supplementary visits (taking place in case of relapse(s) of BPPV)
- Number of relapses per patient from visit 2 to final visit
- Group analysis: vitamin D
1) within reference range at timepoint of study inclusion and treatment within placebo group
2) below reference range at time point of study inclusion and treatment within placebo group
3) within reference range at time point of study inclusion and treatment within verum group
4) below reference range at time point of study inclusion and treatment within verum group
- Correlation of the levels of vitamin D to the number of patients with relapses and to the number of relapses of the single patient (independent of treatment group)

- Absolute Änderung des DHI und VDADL gemessen vor Beginn der Therapie (V1), 2 Monate (V2) und 7 Monate (V3) Monate nach Therapiebeginn sowie am Ende der Behandlungsphase (14 Monate nach Therapiebeginn, V4), zusätzlich wird der DHI und der VDADL bei den Zusatzvisiten (finden statt bei Rezidiv des BPPV) erhoben
- Zahl der Rezidive pro Patient ab Visite 2
Gruppenanalyse nach Vitamin D
1) innerhalb des Referenzbereiches bei Studieneinschluss und Behandlung innerhalb der Placebogruppe im Rahmen der Studie
2) unterhalb des Referenzbereiches bei Studieneinschluss und Behandlung innerhalb der Placebogruppe im Rahmen der Studie
3) Vitamin D innerhalb des Referenzbereiches bei Studieneinschluss und Behandlung innerhalb der Verumgruppe im Rahmen der Studie
4) Vitamin D unterhalb des Referenzbereiches bei Studieneinschluss und Behandlung innerhalb der Verumgruppe im Rahmen der Studie
- Korrelation des Vitamin D Serumspiegels mit Anzahl der Patienten mit Rezidiven sowie Anzahl der Rezidive des Patienten (unabhängig von der Behandlungsgruppe)

E.5.2.1

Timepoint(s) of evaluation of this end point

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

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

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)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

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

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

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

Yes

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

LVLS

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:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

160

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

219

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)

Recruitment of patients takes place in the context of the clinical treatment in the study centers. Further treatment and medical support after the end of the trial will take place in the study centers. After individual respectively complete study dropout patient have the possibility to participate in regular follow up visits at the study Centers.

Die Rekrutierung der Patienten erfolgt im Rahmen der klinischen Behandlung im jeweiligen Prüfzentrum. Die Weiterbehandlung und medizinische Betreuung nach dem Ende der klinischen Prüfung wird dort durchgeführt.
Nach individuellem bzw. komplettem Studienabbruch haben die Patienten die Möglichkeit an regelmäßigen Verlaufskontrollen am Prüfzentrum teilzunehmen.

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

2016-11-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-11-29

P. End of Trial
P.	End of Trial Status	Completed

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