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    Summary
    EudraCT Number:2009-013702-14
    Sponsor's Protocol Code Number:BETNV009
    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:2010-05-05
    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.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2009-013702-14
    A.3Full title of the trial
    Effects of betahistine on central vestibular compensation in acute unilateral vestibular failure: a double-blind, placebo-controlled trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of betahistine on the symptoms of the balance system failure
    A.3.2Name or abbreviated title of the trial where available
    BETAVEST
    A.4.1Sponsor's protocol code numberBETNV009
    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 supportDeutsches Zentrum für Luft- und Raumfahrt (DLR)
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportBundesministerium für Bildung und Forschung (BMBF)
    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
    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 number++4989440076986
    B.5.5Fax number++4989440078795
    B.5.6E-mailingrid.berger@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 Vasomotal
    D.2.1.1.2Name of the Marketing Authorisation holderMylan Healthcare 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
    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 INNBetahistine
    D.3.9.1CAS number 5638-76-6
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number24
    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
    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
    vestibular failure (vestibular neuritis)
    E.1.1.1Medical condition in easily understood language
    failure of the balance system
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10047386
    E.1.2Term Vestibular disorder
    E.1.2System Organ Class 10013993 - Ear and labyrinth disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10029240
    E.1.2Term Neuritis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate medium-term and short-term superiority of betahistine treatment regarding recovery of postural control or spontaneous nystagmus as compared to placebo.
    E.2.2Secondary objectives of the trial
    To establish a patient orientated endpoint “time to recovery from acute symptoms of acute vestibular neuritis” for phase III trials and to demonstrate faster recovery after betahistine treatment compared to placebo. (Key secondary objective)
    To analyze whether superiority of betahistine treatment is kept up to the end of treatment. To quantitatively describe/compare recovery over time vs. placebo and to determine optimal treatment duration. To shed light on the underlying mechanisms (i. e. peripheral vs. central compensation). To check for the occurrence of the adverse effects reported in the summary of medical product characteristics (SmPC) on the drug.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients male or female who are at least 18 years old
    • patient has a history of acute/sub-acute (i.e., within minutes to hours) onset of severe prolonged rotatory vertigo, nausea, and postural imbalance;
    • the clinical examination reveals horizontal-rotatory spontaneous nystagmus (fast phase) toward the unaffected ear without evidence of a central vestibular lesion, and a pathological head-impulse test (i.e., turning the head of the patient rapidly to the right and left while observing provoked compensatory eye movements) that reveals an ipsilateral deficit of the horizontal semicircular canal (Halmagyi & Curthoys 1988);
    • caloric irrigation shows hypo-/unresponsiveness of the horizontal canal of the affected ear, i.e., the maximum slow phase velocity during caloric irri-gation with 30°C and 44°C water should be less than 3°/s on the affected side and the asymmetry between the two sides is >25 percent according to “Jongkees’s vestibular paresis formula” (Jongkees et al. 1962; Fife et al. 2000); and
    • there is a displacement of the subjective visual vertical toward the affected ear without any vertical divergence of the eyes, i.e., without vertical deviation of one eye above the other (Cnyrim et al. 2008).
    • Written informed consent
    E.4Principal exclusion criteria
    • Patients not able to give consent
    • a history of vestibular dysfunction before the acute symptom onset or vestibular symptoms beginning more than 3 days before patients were re-cruited;
    • additional cochlear symptoms, i.e., tinnitus or acute hearing loss before, during, or after the onset of vertigo;
    • central ocular motor or central vestibular dysfunction;
    • any other brainstem or cerebellar signs or symptoms or abnormal findings on the MRI in the brainstem or cerebellum in diffusion-weighted images or hyperintense lesions in T2-weighted images in combination with contrast enhancement in T1-weighted images;
    • other known vestibular disorders such as vestibular migraine, Menière´s disease/syndrome, phobic postural vertigo, benign paroxysmal po-sitioning vertigo;
    • central disorders such as paroxysmal brainstem attacks;
    • contraindications for treatment with betahistine-dihydrochloride as bron-chiale asthma, pheochromocytoma,
    • pregnancy or breast-feeding,
    • severe dysfunction of liver or kidney, ulcer of the stomach or duodenum,
    • treatment with other antihistaminic drugs;
    • known severe coronary heart disease or heart failure,
    • persistent hypertension with systolic blood pressure > 180 mmHg or diastolic BP > 110 mmHg that cannot be controlled by antihypertensive thera-py,
    • life expectancy < 3 months, other serious illness, e.g., severe hepatic, cardiac or renal failure, acute myocardial infarction, neoplasm or a com-plex disease that may confound treatment assessment.
    • The patient has received any investigational medication within 30 days prior to administration of trial medication or is scheduled to receive an in-vestigational drug up to 30 days after end of trial
    • The patient was previously admitted to this trial or simultaneous participa-tion in another clinical trial or participation in any clinical trial involving an administration of investigational medicinal product within 30 days prior to clinical trial beginning.
    E.5 End points
    E.5.1Primary end point(s)
    "Total sway path" (length per time) on a compliant foam-padded posturography platform for postural control, and peak slow phase velocity of the spontaneous nystagmus.
    Measurements at day 10 (medium-term) and day 3 (short-term) after randomization (which is expected to be close to symptom onset).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Measurements at day 10 (medium-term) and day 3 (short-term) after randomization (which is expected to be close to symptom onset).
    E.5.2Secondary end point(s)
    Time in days from randomization to subjective recovery from acute symptoms of acute vestibular neuritis. (Key secondary endpoint)
    "Total sway path" (length per time) on a compliant foam-padded posturography platform for postural control with the eyes closed. Peak slow phase velocity of spontaneous nystagmus without visual fixation obtained from eye-movement recordings 10-40 sec in duration measured on day 28 after randomization (which is expected to be close to symptom onset)
    • "Subjective visual vertical"
    • Slow phase velocity of nystagmus provoked by caloric irrigation as a measure of peripheral vestibular function
    • Handicap / impairment due to vertigo or dizziness - assessed by the Dizziness Handicap Inventory and the Vestibular Disorders Activities of Daily Living score; these parameters will be measured on days 1, 3, 10, and 28 after randomization and
    • All these parameters 8 weeks after randomization.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Parameters will be measured on days 1, 3, 10, and 28 after randomization and 8 weeks after randomization.
    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) 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 concerned6
    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
    The regular end of trial is defined as “Last Patient Last Visit“.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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.1.3Elderly (>=65 years) Yes
    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 state210
    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)
    Treatment of subjects after discontinuation of the trial is not different from the expected normal treatment of that condition.
    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 Decision2010-08-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-08-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-06-10
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