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    Summary
    EudraCT Number:2010-023099-13
    Sponsor's Protocol Code Number:V00251 ST 201 1A
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-12-14
    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 ConcernedFrance - ANSM
    A.2EudraCT number2010-023099-13
    A.3Full title of the trial
    V0251 oral suspension efficacy and tolerance in vestibular neuritis. A randomised double-blind placebo controlled study
    A.4.1Sponsor's protocol code numberV00251 ST 201 1A
    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 -IRPF- PIERRE FABRE INNOVATION
    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 nameL-acetylleucine
    D.3.2Product code V0251 ST 01A
    D.3.4Pharmaceutical form Granules for oral suspension
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNL-acetylleucine
    D.3.9.2Current sponsor codeV0251
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 placeboGranules for oral suspension
    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 aim of this exploratory study is to assess the efficacy of the L-enantiomer V0251 oral form in the treatment of acute episodes of vertigo.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10047393
    E.1.2Term Vestibular neuronitis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to determine the efficacy of the daily administration of 8g of V0251 by oral route during 14 days on vertigo symptom relief in patients suffering from acute vestibular neuritis.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are:
    - To determine the efficacy of the daily administration of 8g of V0251 by oral route during 14 days on central vestibular compensation in patient suffering from acute vestibular neuritis,
    - To determine the tolerance of the daily administration of 8g of V0251 by oral route during 14 days in patient suffering from acute vestibular neuritis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age 18 to 80 years, included
    - Acute vestibular neuritis, defined as:
     Acute or subacute onset of severe, prolonged rotatory vertigo, nausea and postural imbalance that began within 2 days before the inclusion
     Horizontal spontaneous nystagmus with a rotational component toward the unaffected ear (fast phase)
     Suppression or reduction of the nystagmus by visual fixation
     Horizontal gaze-evoked nystagmus (i.e. increase of the nystagmus with gaze directed toward the fast phase of the spontaneous nystagmus and a decrease with gaze directed toward the slow phase)
     Horizontal head impulse test showing an ipsilateral deficit (i.e. rotation of the head toward the affected ear inducing catch-up saccade toward the unaffected ear)
     No skew deviation at the cover test for skew (i.e. no vertical misalignment of the visual axes during ocular alternate cover testing)
    - For woman of child bearing potential: negative urine pregnancy test at inclusion and using an efficient contraceptive (surgical or hormonal birth control or intra-uterine device) for at least 2 months before the study and one month after the end of the study, in order to avoid pregnancy while being exposed to the study treatment.
    - Able to understand the protocol and having signed the written Informed Consent Form. In case of intense vertigo the Informed Consent Form could be signed by a third party (a trustworthy person except an investigator’s team representative or a sponsor representative) after oral consent of the patient, the Informed Consent Form then being signed by the patient within 2 days.
    - Likely to be compliant during the study, in the judgement of the investigator
    - Affiliated to a social security or health insurance system, or is a beneficiary (if applicable in the national regulation)
    E.4Principal exclusion criteria
    Target disease characteristics:
    - Onset of acute vestibular neuritis more than 2 days before the recruitment
    Other diseases:
    - Acute, unilateral tinnitus, during or after the onset of vertigo
    - Acute hearing loss, during or after the onset of vertigo
    - Acute pressure sensation in the ear, during or after the onset of vertigo
    - Acute tympanic membrane perforation
    - Recent history of ear and/or head trauma
    - Signs of central vestibular lesion in the history and in the clinical evaluation (e.g. pure vertical and/or torsional nystagmus, change of nystagmus direction on eccentric gaze away from the direction of the quick phase)
    - Signs of brain, brainstem and/or cerebellar dysfunction (e.g. perioral hypoesthesia, facial paresis/palsy, dysphagia, dysarthria, limb paresis and/or hypesthesia, coordination deficit, confusion/loss of consciousness)
    - Ménière’s disease
    - Benign paroxysmal positioning vertigo
    - Chronic vestibular dysfunction
    - Vestibular migraine
    - Chronic otitis
    - History of hypersensitivity to acetylleucine or excipients
    - History of hypersensitivity to gluten
    - Narrow angle glaucoma
    - Moderate to severe prostatic hypertrophy or bladder neck obstruction
    - Any medical history of major medical, psychiatric illness or surgery which, in the judgement of the investigator, could jeopardize his / her health or is likely to modify his / her handling of the study drug
    Relating to treatments:
    - History of systemic or transtympanic administration of aminoglycosides or any other ototoxic substances
    - Use of the following medications within the last 12 hours prior to inclusion:
     Antihistamines: diphenhydramine, cyclizine, dimenhydrinate, meclozine, hydroxyzine, promethazine
     Calcium antagonists: cinnarizine, flunarizine
     Central antidopaminergics: neuroleptics (benzodiazepines and non-benzodiazepines), except if their dosage is stable for at least one month before the inclusion
     Peripheral antidopaminergics: metoclopramide, alizapride
     Histaminergics: betahistine
     Anticholinergics: scopolamine (hyoscine), homatropine
     GABA agonists: gabapentin, pregabalin
     Acetylleucine, piribedil, ondansetron, piracetam, trimetazidine, ginkgo biloba
     Steroids, except inhaled steroids if their dosage is stable for at least one month before the inclusion
    Others:
    - Is a family member or work associate (secretary, nurse, technician,…) of the Investigator
    - Is pregnant or in post-partum period or a nursing mother
    - Has received treatment with known persistent effects or undergone investigation liable to interfere with the present clinical trial
    - Mentally unable to understand the nature, objectives and possible consequences of the trial; or refusing its constraints
    - Has forfeited his / her freedom by administrative or legal award or is under guardianship
    E.5 End points
    E.5.1Primary end point(s)
    VSS-SF (Vertigo Symptom Scale) and VRS (Verbal Rating scale)
    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 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) 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    last visit last patient
    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 months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    In case of intense vertigo the Informed Consent Form could be signed by a third party after oral consent of the patient, the Informed Consent Form then being signed by the patient within 2 days
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state24
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 168
    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 Decision2011-01-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-12-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-04-30
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