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    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:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-07-21
    Trial 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.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2015-003395-72
    A.3Full 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.3.1Title 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.3.2Name or abbreviated title of the trial where available
    Vitamin D in secondary prevention of BPPV
    Vitamin D zur Sekundärprophylaxe des BPPV
    A.4.1Sponsor's protocol code numberVitD@BPPV
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorHospital of the University of Munich
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBundesministerium für Bildung und Forschung
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital of the University of Munich
    B.5.2Functional name of contact pointDSGZ Studienzentrale
    B.5.3 Address:
    B.5.3.1Street AddressMarchioninistrasse 15
    B.5.3.2Town/ cityMunich
    B.5.3.3Post code81377
    B.5.3.4CountryGermany
    B.5.4Telephone number0049089440076987
    B.5.5Fax number0049089440078795
    B.5.6E-mailivonne.naumann@med.uni-muenchen.de
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Dekristol 1000 I.E.
    D.2.1.1.2Name of the Marketing Authorisation holderMIBE Arzneimittel GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCHOLECALCIFEROL
    D.3.9.1CAS number 67-97-0
    D.3.9.3Other descriptive nameCHOLECALCIFEROL CONCENTRATE (POWDER FORM)
    D.3.9.4EV Substance CodeSUB37745
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical 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.1.1.1Medical 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.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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.2.2Secondary 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.2.3Trial contains a sub-study No
    E.3Principal 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.4Principal 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.5.1Primary 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.5.1.1Timepoint(s) of evaluation of this end point
    - At the end of the study
    - Am Ende der Studie
    E.5.2Secondary 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.5.2.1Timepoint(s) of evaluation of this end point
    - 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)
    - Administation of the remaining secondary end points at the end of the study
    - 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
    - Bestimmung der übrigen sekundären Studienziele erst am Ende der Studie möglich
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial 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.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 59
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 160
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state219
    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
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-11-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-29
    P. End of Trial
    P.End of Trial StatusOngoing
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