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    Summary
    EudraCT Number:2010-018904-94
    Sponsor's Protocol Code Number:2010-018904-94
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-03-14
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2010-018904-94
    A.3Full title of the trial
    EFFICACY AND SAFETY OF INTRAMUSCULAR NERIDRONATE IN OSTEOPOROTIC PATIENTS AFFECTED BY PARKINSON'S DISEASE
    EFFICACIA E SICUREZZA DEL NERIDRONATO INTRAMUSCOLARE NEL TRATTAMENTO DELL OSTEOPOROSI IN PAZIENTI PARKINSONIANI
    A.4.1Sponsor's protocol code number2010-018904-94
    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 SponsorFONDAZIONE SALVATORE MAUGERI - CLINICA DEL LAVORO E DELLA RIABILITAZIONE
    B.1.3.4CountryItaly
    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 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 Yes
    D.2.1.1.1Trade name NERIXIA*IM EV 1F 25MG
    D.2.1.1.2Name of the Marketing Authorisation holderABIOGEN PHARMA SpA
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBisphosphonates
    D.3.9.3Other descriptive nameNeridronic acid
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number25
    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 Yes
    D.3.11.13.1Other medicinal product typeBisfosfonato
    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 placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Osteoporosis in patients affected by Parkinson's disaease at the stages 1-2-3-4 following Hoehn and Yahr criteria
    Osteoporosi in pazienti con m. di Parkinson stadi 1-2-3-4 sec Hoehn e Yahr
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level SOC
    E.1.2Classification code 10028395
    E.1.2Term Musculoskeletal and connective tissue disorders
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue 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 safety and the improvement in lumbar BMD after 24 months of intramuscular neridronate at the monthly dose of 25 mg.
    Valutare a 24 mesi l efficacia e la sicurezza del NE al dosaggio mensile di 25 mg im in termini di miglioramento della BMD lombare.
    E.2.2Secondary objectives of the trial
    To evaluate the safety and the improvement in femural BMD after 24 months of intramuscular neridronate at the monthly dose pf 25 mg. To evaluate the ability of neridronate to prevent femural fractures in patients affected by Parkinson's disease. To evaluate the effects of intramuscular neridronate on markers of bone turnover in osteoporotic patients affected by Parkinson's disease. To evaluate the patients' adherence to the intramuscular treatment with neridronate.
    Valutare a 24 mesi l efficacia e la sicurezza del NE IM al dosaggio mensile di 25 mg im in termini di miglioramento della BMD del collo femorale e di prevenzione delle fratture osteoporotiche in pazienti parkinsoniani. Valutare inoltre le variazioni degli indici del turnover osseo in corso di terapia con NE IM 25 mg/mese in pazienti osteoporotici parkinsoniani. Valutare l aderenza allo schema terapeutico proposto.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    OTHER SUBSTUDIES:


    ALTRI SOTTOSTUDI:
    Aderenza alla terapia

    E.3Principal inclusion criteria
    ° males and females aged between 65 and 80 °patients affected by Parkinson's disease following international guidelines, in treatment with levodopa and/or dopamine agonists ° spine or femoral neck BMD T-score (using DXA) at least < -2.5 ° previuos low adherence or gastric/oesophageal intolerance to oral bisphosphonates stopped at least 3 months before the enrolment written informed consent to the treatment
    ° maschi e femmine dai 65 agli 80 anni ° affetti da malattia di Parkinson diagnosticata sec. le linee guida internazionali in trattamento farmacologico con levodopa e/o dopamino-agonisti. ° valori della BMD valutati con metodica DXA &lt; -2.5DS in almeno una delle 2 sedi principali (colonna lombare e collo femore) ° mancata aderenza all utilizzo dei bisfosfonati orali o provata intolleranza gastrica. In questo ultimo caso e' previsto un wash-out di almeno 3 mesi prima dell inizio del presente studio. ° consenso informato
    E.4Principal exclusion criteria
    °patients in efficaciuos treatment with oral bisphosphonates or SERMS °patients in treatment with oestrogens, glucocorticoids, calcitonin during last 12 months ° previous femural osteoporotic fractures °patients affected by bone metabolic diseses othe than osteoporosis, osteomalacia, hyperparathyroidism, hypocalcemia ° affected by renal, cardiovascular or neoplastic diseases ° affected by neurological diuseases other than Parkinson's disease ° affected by Parkinson's disease at stages 0 and 5 following Hoehn and Yahr criteria
    ° in trattamento efficace con bisfosfonati orali o SERMS ° in trattamento con estrogeni, glucocorticoidi, calcitonina negli ultimi 12 mesi. ° precedenti fratture osteoporotiche di femore ° affetti da malattie metaboliche ossee diverse dall osteoporosi, iperparatiroidismo, osteomalacia, ipocalcemia. ° affetti da malattie renali, cardiovascolari e neoplastiche ° affetti da malattie psichiatriche e/o neurologiche rilevanti diverse dalla malattia di Parkinson. ° Malattia di Parkinson allo stadio 0 e 5 sec. Hoehn and Yahr.
    E.5 End points
    E.5.1Primary end point(s)
    IMprovement in luimbar BMD at 24 months
    Incremento della BMD lombare a 24 mesi
    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) 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 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.8.4.1Number of sites anticipated in Member State concerned1
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    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.1.1Number of subjects for this age range: 0
    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) No
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state60
    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 Decision2010-05-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-05-31
    P. End of Trial
    P.End of Trial StatusOngoing
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