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    Summary
    EudraCT Number:2015-000388-15
    Sponsor's Protocol Code Number:VesPa
    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:2015-12-09
    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 number2015-000388-15
    A.3Full title of the trial
    Prophylactic treatment of vestibular paroxysmia with carbamazepine: a prospective, randomized, placebo-controlled, cross-over, multi-center trial
    Therapie der Vestibularisparoxysmie mit Carbamazepin: 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
    Treatment of vestibular paroxysmia with carbamazepine
    Carbamazepin zur Therapie der Vestibularisparoxysmie
    A.3.2Name or abbreviated title of the trial where available
    VesPa
    VesPa
    A.4.1Sponsor's protocol code numberVesPa
    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 SponsorUniversity 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 Timonil retard
    D.2.1.1.2Name of the Marketing Authorisation holderDesitin 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 INNCarbamazepine
    D.3.9.1CAS number 298-46-4
    D.3.9.3Other descriptive nameCARBAMAZEPINE
    D.3.9.4EV Substance CodeSUB06113MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 vestibular paroxysmia are brief attacks of rotatory or postural vertigo lasting seconds to a few minutes with or without ear symptoms (tinnitus and hypoacusis). As in trigeminal neuralgia or hemifacial spasm, it is assumed that a neurovascular cross-compression of the eighth cranial nerve is the cause of the attacks.
    Patienten mit Vestibularisparoxysmei leiden unter Sekunden bis wenige Minuten andauernden Schwindelattacken, welche von Ohrsymptomen begleitet werden können. Es wird angenommen, dass die Erkrankung ähnlich wie die Trigeminusneuralgie durch einen Gefäß-Nerven-Kontakt (des achten Hirnnervens) hervorgerufen wird.
    E.1.1.1Medical condition in easily understood language
    The main symptoms of vestibular paroxysmia are brief attacks of vertigo lasting seconds to a few minutes, sometimes with ear symptoms.
    Patienten mit Vestibularisparoxysmie leiden unter sich wiederholenden Schwindelattacken, welche Sekunden bis wenige Minuten andauern und manchmal von Ohrsymptomen begleitet werden.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the comparison of carbamazepine and placebo is to demonstrate that CBZ is efficacious in reducing the number of vertigo attacks in patients with vestibular paroxysmia measured by a diary.
    Das primäre Studienziel ist der Nachweis der Reduzierung von Schwindelattacken durch Carbamazepin bei Patienten mit Vestibularisparoxysmie, gemessen mit einem Schwindeltagebuch.
    E.2.2Secondary objectives of the trial
    To demonstrate that carbamazepine is efficacious in
    1) improving impairment and qualitiy of life (assessed by the Dizziness Handicap Inventory (DHI), the Vestibular Disorders Activities of Daily Living Scale (VDADL) and the EQ-5D-5L)
    2) shorten the average duration of the attacks and median severity of the attacks of vertigo
    3) shorten the hyperventilation induced vertigo and/or nystagmus
    4) reduce days with vertigo
    To assess the side effects, adverse events, SAEs SUSAR
    Nachzuweisen, dass Carbamazepin wirksam ist bei
    1) Quantifizierung der Einschränkung aufgrund des Schwindels, Erhebung mittels „Dizziness Handicap Inventory“ (DHI) und „Vestibular Disorders Activities of Daily Living Scale“ (VDADL)] sowie Einschränkung der Lebensqualität (Erhebung mittels EQ-5D-5L) während der letzten vier Wochen der Behand-lungsphasen
    2) Quantitative Beschreibung und Vergleich der durchschnittlichen Dauer und Stärke der Attacken während der zweimonatigen Behand-lungsphase, Erhebung tagebuchbasiert
    3) Hyperventilationsinduzierbarer Schwindel und/oder Nystagmus
    4) Reduktion der Anzahl der Tage mit Schwindelattacken
    Untersuchung der Nebenwirkungen, AE, SAE, SUSAR
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Written Informed Consent
    - Over 18 years of age
    - at least 5 attacks in the three months prior to inclusion
    - attacks last less than 5 minutes
    - course of attacks is stereotypical of the individual patient
    - spontaneous occurence or provocation due to certain head movements
    - The symptoms cannot be explained by another disease, in particular Menière’s disease, vestibular migraine, BPPV or perilymph fistula.
    - The ability to follow study instructions and likely to attend and complete all visits
    - Female subjects with childbearing potential and fertile men are eligible if they use a medically accepted highly effective contraceptive method.
    - Schriftlich dokumentierte Einwilligung zur Teilnahme an der Studie liegt vor
    - Alter ≥ 18 Jahre
    - Mindestens 5 Schwindelattacken in den drei Monaten vor der Screeninguntersuchung
    - Dauer der Attacken unter fünf Minuten
    - Stereotyper Attackenablauf im einzelnen Patienten
    - Spontanes Auftreten oder Provokation durch bestimmte Kopfbewegungen
    - Die Symptome können nicht durch eine andere Erkrankung erklärt werden, insbesondere Morbus Menière, Vestibuläre Migräne, BPPV oder Perilymphfistel
    - Patient ist in der Lage, die Studienanweisungen zu befolgen und die wahrscheinlich alle erforderlichen Studienvisiten einhalten werden (Compliance)
    - Bereitschaft teilnehmender gebärfähiger Frauen oder fertiler Männer hocheffektiv zu verhüten
    E.4Principal exclusion criteria
    - Other vestibular disorders such as Menière’s disease, BPPV, vestibular migraine or perilymph fistula at the time of inclusion
    - Paroxysmal brainstem attacks after stroke or in multiple sclerosis
    - Episodic ataxia
    - Absence seizures or types of epilepsy, which include absence seizures
    - Intake of other antiepileptic drugs
    - Severe hepatic, cardiac or renal failure
    - Known intolerance to carbamazepine
    - Known intolerance to structurally related substances, for example tricyclic antidepressants
    - Known damage of the bone marrow or aute and/or previous severe haematological diseases
    - Atrioventricular block
    - Active Pregnancy or breast-feeding
    - Known hepatic porphyria
    - Required therapy with MAO-Inhibitors, voriconazol or stiripentol
    - Hypo- or hypernatraemia
    - Known Myotonic dystrophia
    - Known Alcoholabuse
    - Life expectancy under 12 months
    - Participation in another study with an investigational drug or device within the last 30 days before participating of the study
    - Andere aktive Schwindelerkrankungen wie Morbus Menière, Vestibuläre Migräne, BPPV, Perilymphfistel zum Zeitpunkt der Screeningvisite
    - Paroxysmale Hirnstammattacken, z.B. bei Z.n. Schlaganfall
    oder Multiple Sklerose
    - Episodische Ataxie
    - Absencen bzw. gemischte Epilepsieformen, die solche beinhalten
    - Einnahme von Antiepileptika
    - Schwere Herz-, Leber- oder Niereninsuffizienz
    - Bekannte Unverträglichkeit gegenüber CBZ
    - Bekannte Überempfindlichkeit gegen strukturell verwandte Me-dikamente wie trizyklische Antidepressiva
    - Bekannte akute Knochenmarksschädigung oder vorhergegan-gene schwerwiegende hämatologische Erkrankungen
    - Atrioventrikulärer Block
    - Eine aktive oder geplante Schwangerschaft, Stillzeit
    - Bekannte hepatische Porphyrie
    - Notwendige Therapie mit MAO-Inhibitoren, Voriconazol oder Stiripentol während der Studie
    - Hypo- oder Hypernatriämie
    - Bekannte myotone Dystrophie
    - Bekannter Alkoholabusus
    - Lebenserwartung unter 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 vertigo attacks per month during the 6-week treatment periods
    Anzahl der Schwindelattacken pro Monat während der sechswöchigen Behandlungsphasen
    E.5.1.1Timepoint(s) of evaluation of this end point
    Assessment with a diary during the 6week treatment period and the 6-week placebo period
    Collection at visit V5 and V9 at the end of the treatment periods
    Untersuchung mittels Patiententagebuch während der sechswöchigen Behandlungs- und Placebophase
    Einsammeln der Tagebücher am Ende der jeweiligen Phasen bei Visite V5 und V9
    E.5.2Secondary end point(s)
    1) Days with vertigo during the two treaments periods
    2) Change of the Dizziness Handicap Inventory (DHI), the Vestibular Disorders Activities of Daily Living Scale (VDADL) and the EQ-5D-5L), administration evaluated at the start as well as the end of both treatment periods and the last study visit
    3) average (per day) duration of the attacks of vertigo and median severity of the attacks of vertigo reported by the patient during both treatment periods
    4) change of hyperventilation induced vertigo and/or nystagmus, administration at the start, at the end of both treatment periods and at the end of the study
    1) Anzahl der Tage mit Schwindelattacken während der sechswöchigen Behandlungsphasen
    2) Absolute Änderung des DHI, des VDADL und des EQ-5D-5L, gemessen vor Beginn der Therapie (V1) sowie jeweils am Ende der sechswöchigen Behandlungsphase (V5, V9), sowie nach Beendigung der Auswaschphase (V10)
    3) Durchschnittliche (pro Tag) vom Patienten angegebene Attackendauer und -stärke während der sechswöchigen Behandlungsphasen
    4) Veränderung der Nachweisbarkeit und Stärke eines hyperventilationsinduzierten Schwindels und/oder Nystagmus gemessen vor Beginn der Therapie (V1) sowie jeweils am Ende der sechswöchigen Behandlungsphase (V5, V9), sowie nach Beendigung der Auswaschphase (V10)
    E.5.2.1Timepoint(s) of evaluation of this end point
    administration at the start, at the end of both treatment periods and at the end of the study
    Durchführung vor Beginn der Therapie (V1), jeweils am Ende der sechswöchigen Behandlungsphasen (V5, V9), sowie nach Beendigung der Studie (V10)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    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) No
    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 No
    E.8.1.6Cross over Yes
    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 concerned4
    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 days15
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 53
    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 state153
    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)
    All patients are already known in the study centers and will be under physician's care after the end of the clinical trial. The medical file will contain details about the participation in the trial with all collected clincial findings. If a patient improved under the drug tested in the trial, further treatment with this IMP can be offered by the clinical centers.
    Alle Patienten, die an dieser klinischen Studie teilnehmen werden bereits im jeweiligen Prüfzentrum behandelt, so dass die weitergehende Versorgung dort auch nach Ende der klinischen Prüfung erfolgen kann. Falls die Patienten durch die Einnahme des Prüfpräparates eine Besserung merken, wird Ihnen die Weiterbehandlung angeboten. Auch nach individuellen oder kompletten 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 Decision2016-04-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-08-31
    P. End of Trial
    P.End of Trial StatusOngoing
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