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    Summary
    EudraCT Number:2013-005122-33
    Sponsor's Protocol Code Number:NIMOBET-1
    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:2014-01-09
    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 number2013-005122-33
    A.3Full title of the trial
    A phase II, randomized, double-blind, parallel groups study to assess the efficacy and safety of Nimodipine 20 mg + Betahistine 16 mg versus Placebo + Betahistine 16 mg in the treatment of vertigo
    Studio di fase II, randomizzato, in doppio cieco a gruppi paralleli per valutare l’efficacia e la sicurezza di Nimodipina 20 mg + Betaistina 16 mg versus Placebo + Betaistina 16 mg nel trattamento della vertigine
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase II, randomized, double-blind, parallel groups study to assess the efficacy and safety of Nimodipine 20 mg + Betahistine 16 mg versus Placebo + Betahistine 16 mg in the treatment of vertigo
    A phase II, randomized, double-blind, parallel groups study to assess the efficacy and safety of Nimodipine 20 mg + Betahistine 16 mg versus Placebo + Betahistine 16 mg in the treatment of vertigo
    A.4.1Sponsor's protocol code numberNIMOBET-1
    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 SponsorMDM S.p.A.
    B.1.3.4CountryItaly
    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 supportMDM S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMDM S.p.A.
    B.5.2Functional name of contact pointServizio Segreteria MDM
    B.5.3 Address:
    B.5.3.1Street AddressVia Volturno, 29/b
    B.5.3.2Town/ cityMONZA
    B.5.3.3Post code20052
    B.5.3.4CountryItaly
    B.5.4Telephone number0039039 3909110
    B.5.5Fax number0039039 322888
    B.5.6E-mailmdm@mdmspa.com
    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 ISKIDROP 30 mg/ 0,75 ml gocce orali, soluzione
    D.2.1.1.2Name of the Marketing Authorisation holderMDM S.p.A., Viale Papiniano, 22/b – 20123 Milano
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameISKIDROP 30 mg/ 0,75 ml gocce orali, soluzione
    D.3.4Pharmaceutical form Oral drops, solution
    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 INNNIMODIPINE
    D.3.9.1CAS number 66085-59-4
    D.3.9.4EV Substance CodeSUB09297MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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.IMP: 2
    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 Betaistina ratiopharm 16 mg compresse
    D.2.1.1.2Name of the Marketing Authorisation holderratiopharm GmbH, Graf-Arco Str. 3 - 89079 Ulm (Germania)
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameBETAISTINA RATIOPHARM 16 mg compresse
    D.3.4Pharmaceutical form Tablet
    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.3.9.4EV Substance CodeSUB05794MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number16
    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 placeboOral drops, solution
    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
    Vertigo
    Vertigine
    E.1.1.1Medical condition in easily understood language
    Vertigo
    Vertigine
    E.1.1.2Therapeutic area Diseases [C] - Ear, nose and throat diseases [C09]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10047340
    E.1.2Term Vertigo
    E.1.2System Organ Class 10013993 - Ear and labyrinth 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 evaluate the efficacy of Nimodipine 20 mg + Betahistine 16 mg (b.i.d) for the treatment of vertigo, compared to Betahistine 16 mg (b.i.d), as assessed by the Dizziness Handicap Inventory (DHI) after 4 weeks of treatment
    Valutare l'efficacia di Nimodipina 20 mg + Betaistina 16 mg (b.i.d) nel trattamento della vertigine, rispetto a Betaistina 16 mg (b.i.d), misurata tramite la Dizziness Handicap Inventory (DHI) dopo 4 settimane di trattamento
    E.2.2Secondary objectives of the trial
    1. To evaluate the self-perceived vertigo disability as assesed by the change of Mean Vertigo Score (MVS), based on the sum of vertigo, dizziness, unsteadiness divided by three
    2. To evaluate the quality of life in patients with vertigo, using the SF-12 questionnaire

    ▪ Safety Objectives
    1. To investigate the safety and tolerability of Nimodipine 20 mg + Betahistine 16 mg (b.i.d.)
    1. Valutare la disabilità auto-percepita dovuta a vertigine tramite il cambiamento del Mean Vertigo Score (MVS), calcolato come somma dei valori relativi a vertigini, capogiri e instabilità diviso per tre
    2. Valutare la qualità della vita in pazienti con vertigine utilizzando il questionario SF-12

    ▪ Obiettivi di sicurezza (Safety)
    1. Studiare la sicurezza (safety) e la tollerabilità di Nimodipina 20 mg + Betaistina 16 mg (b.i.d)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age > 20 years (both gender)
    2. Patients with a complaint of vertigo attacks lasting at least 3 months
    3. Baseline total DHI score > 40
    4. Negative pregnancy test for women of childbearing potential (to be performed at Visit 1) and use of an acceptable mean of contraception in the previous 2 months and for whole duration of the study
    5. Signed Informed Consent
    1. Età > 20 anni (entrambi i sessi)
    2. Pazienti che presentano attacchi vertiginosi della durata di almeno 3 mesi
    3. Punteggio totale DHI > 40 alla baseline
    4. Test di gravidanza negativo per le donne in età fertile (da effettuare alla Visita 1) e l'uso di un mezzo accettabile di contraccezione nel corso degli ultimi 2 mesi e per tutta la durata dello studio
    5. Consenso Informato firmato
    E.4Principal exclusion criteria
    1. Cerebellopontine lesions, multiple sclerosis, acustic neuroma or other CNS tumor, as demonstrated by a CT scan or NMR (will be valid a CT scan/NMR performed within 3 months from visit 1)
    2. Patients treated with calcium channel blockers, antihistamines, rifampicin, phenobarbital, phenytoin or carbamazepine
    3. Known allergies, hypersensitivity, or intolerance to nimodipine or betahistine or any excipients used in their manufacture
    4. Patient with clinical gastrointestinal malabsorption
    5. Patients with blood pressure <100/70 mmHg
    6. Patients with bronchial asthma
    7. Patients with a history of peptic ulcer
    8. Patients with urticaria, exanthema or allergic rhinitis
    9. Patients with phaeochromocytoma
    10. Pregnancy, breast feeding
    11. Use of vestibular suppressants drugs 7 days prior to study treatment start
    12. ALT > 1.5 upper normal limit (UNL), AST > 1.5 UNL, alkaline phosphatase > 1.5 UNL, total bilirubin > 2 UNL, creatinine > 1.5 UNL
    13. Treatment with another investigational agent within the last 30 days
    14. Subjects with evidence of clinically unstable disease, as determined by medical history, physical examination, that, in the Investigator's opinion, preclude entry into the study
    15. Known or suspected history of alcohol or drug abuse based on medical history, physical examination, or the Investigator's clinical judgment
    1. Lesione ponto-cerebellare, sclerosi multipla, neurinoma acustico o altri tumori del SNC, come dimostrato da TAC o RMN (sarà valida una TAC/RMN eseguita entro 3 mesi dalla visita 1)
    2. Pazienti trattati con calcio-antagonisti, antistaminici, rifampicina, fenobarbital, fenitoina or carbamazepina
    3. Ipersensibilità nota al principio attivo (nimodipina, betaistina) o ad uno qualsiasi degli eccipienti
    4. Pazienti affetti da malassorbimento
    5. Pazienti con valori di pressione arteriosa <100/70 mmHg
    6. Pazienti affetti da asma bronchiale
    7. Pazienti con storia di ulcere peptiche
    8. Pazienti affetti da orticaria, esantema, rinite allergica
    9. Pazienti con feocromocitoma
    10. Gravidanza, allatamento
    11. Uso di farmaci vestibolo-soppressori 7 giorni prima dell'inizio del trattamento
    12. ALT > 1.5 limite superiore della norma (UNL), AST > 1.5 UNL, fosfatasi alcalina > 1.5 UNL, bilirubina totale > 2 UNL, creatinina > 1.5 UNL
    13. Pazienti che abbiano preso parte ad altre sperimentazioni cliniche nei 30 giorni precedenti
    14. Soggetti che presentano condizioni cliniche instabili basate sull'anamnesi e sull'esame fisico e che secondo il giudizio dello sperimentatore precludono la partecipazione allo studio
    15. Nota o sospetta storia di abuso di alcol o di droghe basata sull'anamnesi, sull'esame fisico o sulla valutazione clinica dello sperimentatore
    E.5 End points
    E.5.1Primary end point(s)
    Reduction of DHI after 4 weeks of treatment
    Riduzione della DHI dopo 4 settimane di trattamento
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 4 weeks of treatment
    Dopo 4 settimane di trattamento
    E.5.2Secondary end point(s)
    1. Reduction of MVS after 4 weeks of treatment
    2. Change in SF-12 scores after 4 weeks of treatment
    3. Percentage of patients presenting adverse events
    4. Number of patients presenting laboratorial changes
    1. Riduzione della MVS dopo 4 settimane di trattamento
    2. Variazione punteggio della SF-12 dopo 4 settimane di trattamento
    3. Percentuale di pazienti che presentano eventi avversi
    4. Numero di pazienti che presentano variazioni significative degli esami di laboratorio
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. After 4 weeks of treatment
    2. After 4 weeks of treatment
    3. During all the study
    4. After 4 weeks of treatment
    1. Dopo 4 settimane di trattamento
    2. Dopo 4 settimane di trattamento
    3. Durante tutta la durata dello studio
    4. Dopo 4 settimane di trattamento
    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) 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.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned 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.1.2.1Number of subjects for this age range: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state80
    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)
    None
    Nessuno
    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 Decision2014-01-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-04
    P. End of Trial
    P.End of Trial StatusCompleted
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