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    Summary
    EudraCT Number:2007-005054-23
    Sponsor's Protocol Code Number:V00251 IV 201
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-03-23
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2007-005054-23
    A.3Full title of the trial
    A DOUBLE-BLIND PLACEBO CONTROLLED STUDY OF 1g, 2g, AND 4 g V0251 EFFICACY AND TOLERANCE IN VESTIBULAR NEURITIS
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberV00251 IV 201
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPIERRE FABRE MEDICAMENT
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 No
    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.3.1Product nameACETYL-L-LEUCINE
    D.3.2Product code V0251
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNACETYL-L-LEUCINE
    D.3.9.1CAS number 1188-21-2
    D.3.9.2Current sponsor codeV0251
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    V0251 is a new investigational agent which is being developped for the treatment of symptomatic vertiginous crisis.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10047339
    E.1.2Term Vertiginous syndromes and other disorders of vestibular system
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine efficacy on central vestibular compensation of 3 doses versus placebo of L-acetylleucine within 4 days of intravenous administration in patient hospitalised for acute vestibular neuritis
    E.2.2Secondary objectives of the trial
    To determine treatment duration - To assess a dose-effect relationship - To determine tolerance of 3 doses of L-acetylleucine within 4 days of intravenous administration in patient hospitalised for vestibular neuritis. - To determine optimal dose (efficacy and tolerance) of L-acetylleucine within 4 days of intravenous administration in patient hospitalised for vestibular neuritis. - To evaluate the primary criteria and the endpoint choices
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patient aged above 18 years, - Patient admitted to the hospital for vertigo related to acute vestibular neuritis, - Vestibular neuritis (acute unilateral vestibulopathy) defined as : acute or subacute onset of severe, prolonged rotatory vertigo, nausea and postural imbalance that began less than 48h before the inclusion visit, horizontal spontaneous nystagmus with a rotational component beating toward the unaffected ear (fast phase), without evidence of central vestibular lesion, peak slow phase velocity during caloric irrigation with 30C warm and 44C hot water less than three degrees per second on the affected side for each irrigation ; with an asymetry between the two sides more than 25 percent according to Jongkees’ s formula during the bithermal caloric test which will be performed 3 days after treatment (initiated at inclusion visit), - Negative pregnancy test at inclusion for woman of child bearing potential and using an efficient contraceptive (implants, injectables, combined oral contraceptives, some intra-uterine devices, sexual abstinence or vasectomised partner related to note 3 of the CPMP/ICH/286/95, see appendix 17.5) for at least 2 months before the study and one month after the end of the study, - Patient accepting to participate to the study and able to understand and sign an approved Informed Consent Form, - Patient able to understand the protocol and to come to the control visits, - Patient who, in the judgement of the investigator is likely to be compliant during the study - Registered with a social security or health insurance system
    E.4Principal exclusion criteria
    * Criteria related to pathologies - Vestibular dysfunction before the acute onset of symptoms, - Acute, unilateral (same side as the affected ear) tinnitus during, or after the onset of vertigo, ¬- Acute hearing loss during, or after the onset of vertigo, - Central ocular motor dysfunction - Central vestibular dysfunction - Symptoms of cerebellar disorder - Symptoms of central neurological disorder - History or symptoms of vestibular migraine - Recent history of ear and/or head trauma, - Tympanic membrane perforation - Chronic otitis, * Criteria related to treatments - Patient with history of hypersensitivity to ace`tylleucine or excipients, - History of systemic or transtympanic administration of aminoglycosides or any other ototoxic substances, - More than one antivertigo drug oral or intravenous administration before inclusion visit, - Hypnotics, antidepressants, if prescription initiated or modified within the 3 previous months before inclusion visit, * Criteria related to the population - Medical history of major medical, psychiatric illness or surgery which, in the judgement of the investigator, puts them ‘at risk’ or is likely to modify their handling of the study drug, - Female who is pregnant or breast feeding or not using contraception, or planning to become pregnant, - Participation to an other clinical trial in the previous month or during the study, - Patient who, is not able to understand the information (for linguistic or psychiatric reasons) and to give informed consent, - Patient who, in the judgement of the investigator, is not likely to be compliant during the study, - Patient who has forfeited his/her freedom by administrative or legal decision, or who is under guardianship.
    E.5 End points
    E.5.1Primary end point(s)
    PEAK SLOW PHASE EYE VELOCITY OF HORIZONTAL SPONTANEOUS NYSTAGMUS ON DAY 4
    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 No
    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) No
    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.8.3 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 Yes
    E.8.5.1Number of sites anticipated in the EEA38
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 120
    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 Decision2008-06-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-06-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-04-19
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