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    Summary
    EudraCT Number:2013-000356-18
    Sponsor's Protocol Code Number:25051974
    National Competent Authority:Netherlands - Competent Authority
    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
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2013-000356-18
    A.3Full title of the trial
    Effect of repeated intranasal cobalamin administration on cobalamin deficiency in elderly
    Effect van herhaalde intranasale toediening van cobalamine op de cobalamine deficientie bij ouderen.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of intranasal therapy for vitamin B12 deficiency
    Het effect van intranale therapie bij vitamine B12 deficientie
    A.3.2Name or abbreviated title of the trial where available
    ERICA
    ERICA
    A.4.1Sponsor's protocol code number25051974
    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 SponsorStichting Apotheek der Haarlemse Ziekenhuizen
    B.1.3.4CountryNetherlands
    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 supportStichting Apotheek der Haarlemse Ziekenhuizen
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationStichting Apotheek der Haarlemse Ziekenhuizen
    B.5.2Functional name of contact pointMonique Tillemans
    B.5.3 Address:
    B.5.3.1Street AddressBoerhaavelaan 24
    B.5.3.2Town/ cityHaarlem
    B.5.3.3Post code2035RC
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031235464054
    B.5.5Fax number0031235464028
    B.5.6E-mailmtillemans@sahz.nl
    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 nameCyanocobalamin, nasal spray 500 microgram/spray
    D.3.4Pharmaceutical form Nasal spray, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntranasal use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCYANOCOBALAMIN
    D.3.9.1CAS number 68-19-9
    D.3.9.3Other descriptive nameCYANOCOBALAMIN
    D.3.9.4EV Substance CodeSUB06837MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5495
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cobalamin (vitamin B12) deficiency
    Cobalamine (vitamine B12) deficientie
    E.1.1.1Medical condition in easily understood language
    Vitamin B12 deficiency
    Vitamine B12 tekort
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    In this study we investigate the effects of two intranasal cobalamin dosing regimens i.e. 1000 microgram administered once every three days and 1000 microgram administered once every day for two weeks, followed by once every week in elderly cobalamin deficient subjects on total transcobalamin and holotranscobalamin concentration.

    The objective of this study is to establish the optimal intranasal cobalamin dosing regimen in elderly.
    In deze studie wordt het effect van twee intranasale cobalamine doseerregimes; 1000 microgram elke 3 dagen toegediend en 1000 microgram elke dag toegediend gedurende twee weken, gevolgd door 1000 microgram elke week bij cobalamine deficiente ouderen op de transcobalamine en holotranscobalamine serum concentraties met elkaar vergeleken.
    Het doel van dit onderzoek is om het optimale intranasale doseerregime bij ouderen vast te stellen.
    E.2.2Secondary objectives of the trial
    Not applicable
    Niet van toepassing
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - 65 years of age or over
    - Total cobalamin serum level less than 250 pmol/l
    - Suspect for cobalamin deficiency; hyperhomocysteinemia (> 15 micromoles/l) and/or 2 or more symptoms of cobalamin deficiency e.g. fatigue, memory impairment, irritability, personality changes, muscle weakness, depression, poor appetite, weight loss
    - Capable of understanding the study information
    - Informed consent
    - 65 jaar of ouder
    - Cobalamineconcentratie in serum kleiner dan 250 pmol/l
    - Aanwijzigingen voor cobalamine deficientie; hyperhomocysteinemie (> 15 micromol/l) en/of twee of meer symptomen van cobalamine deficientie zoals moeheid, geheugenstoornissen, geirriteerdheid, gedragsveranderingen, spierzwakheid, depressie, verminderde eetlust, gewichtsverlies
    - In staat om de studieinformatie te begrijpen
    - Informed consent
    E.4Principal exclusion criteria
    - Concomitant use intranasally administered medication
    - Chronic rhinitis
    - Use of cobalamin containing dietary supplements
    - Severe Renal impairment i.e. MDRD less than 20 ml/min
    - Gelijktijdig gebruik van andere nasaal toegediende medicatie
    - Chronische rhinitis
    - Gebruik van cobalamine bevattende voedingssupplementen
    - Nierinsufficientie MDRD klaring kleiner dan 20 ml/min
    E.5 End points
    E.5.1Primary end point(s)
    Change in total transcobalamin and holotranscobalamin (holoTC) serum concentrations over time.
    Verandering in totale transcobalamine en holotranscobalamine (holoTC) serumconcentraties in de tijd.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Total transcobalamin and holotranscobalamin serum concentrations will be established at t = 11, 7, 14, 30, 60 and 90 days.
    Totale transcobalamine en holotranscobalamine serum concentraties worden bepaald op t = 1, 7, 14, 30, 60 en 90 dagen.
    E.5.2Secondary end point(s)
    Changes in methylmalonic acid (MMA) and homocysteïne (tHcy) serum concentrations and changes in Geriatric Depression Scale (GDS) 5 and Mini Mental State Examination (MMSE) scores over time.
    Veranderingen in methylmalonzuur en homocysteine serumconcentraties en veranderingen in de GDS (5) en MMSE scores in de tijd.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Methylmalonicacid and homocysteine serumconctrations will be evaluted at t = 1, 14 and 90 days
    GDS and MMSE scores will be evaluated at t = 1 and 90 days
    methylmalonzuur en homocysteine serumconcentraties worden bepaald op dag 1, 14 en 90.
    De GDS en MMSE scores zullen op dag 1 en 90 worden bepaald.
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    zelfde product maar met een ander doseerregime
    same medicinal product but different dosing regimen
    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
    The last visit of the last subject undergoing the trial.
    Het laatste bezoek van de laatste patient in het onderzoek.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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
    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)
    In case the patient still needs treatment for cobalamin deficiency, the patient will receive the standard care for cobalamin deficiency.
    Wanneer een patient na de studie nog (onderhouds) behandeling nodig heeft voor de cobalamine deficientie, zal de patient de standaard behandeling voor cobalamine deficientie krijgen.
    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 Decision2023-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-03-17
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