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    The EU Clinical Trials Register currently displays   41200   clinical trials with a EudraCT protocol, of which   6743   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2013-000101-24
    Sponsor's Protocol Code Number:200453
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-05-08
    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 ConcernedFinland - Fimea
    A.2EudraCT number2013-000101-24
    A.3Full title of the trial
    The effect of antiherpes medication with valaciclovir on cognition and function in patients with Alzheimer disease
    The HEVALITZ Study - Pilot study
    Hiljaisen herpesvirusinfektion merkitys Alzheimerin taudin patofysiologiassa
    Hoitotutkimus valasikloviirin vaikutuksesta kotona-asuvien Alzheimerpotilaiden toimintakykyyn ja kognitioon HEVALITZ-tutkimus - pilottitutkimusvaihe
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of herpesviridae in the treatment of Alzheimer disease
    Herpesviruksen hoidon merkitys Alzheimerin taudin hoidossa
    A.3.2Name or abbreviated title of the trial where available
    HEVALITZ - Pilot study
    HEVALITZ-pilottitutkimus
    A.4.1Sponsor's protocol code number200453
    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 SponsorUniversity of Helsinki
    B.1.3.4CountryFinland
    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 supportUniversity of Helsinki
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Helsinki
    B.5.2Functional name of contact pointDepartment of Medicine
    B.5.3 Address:
    B.5.3.1Street AddressStenbackinkatu 29 A
    B.5.3.2Town/ cityHelsinki
    B.5.3.3Post code00029
    B.5.3.4CountryFinland
    B.5.4Telephone number358405969285
    B.5.6E-mailtimo.strandberg@oulu.fi
    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 Valtrex/Valavir (valaciclovir)
    D.2.1.1.2Name of the Marketing Authorisation holderGSK, Orion Pharma
    D.2.1.2Country which granted the Marketing AuthorisationFinland
    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 nameValtrex/valavir
    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 INNVALACICLOVIR
    D.3.9.1CAS number 124832-26-4
    D.3.9.4EV Substance CodeSUB00003MIG
    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
    Alzheimer disease
    Alzheimerin tauti
    E.1.1.1Medical condition in easily understood language
    Alzheimer disease
    Alzheimerin tauti
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    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
    ”Proof-of-concept”-type of trial whether it is possible to slow down cognitive and functional decline among patients with stabile and early Alzheimer disease with valaciclovir - pilot study with valaciclovir only
    ”Proof-of-concept”-tyyppisessä tutkimuksessa voidaan stabiilissa vaiheessa olevien, varhaista/lievää Alzheimerin tautia sairastavien potilaiden kognition ja toimintakyvyn heikentymistä merkittävästi hidastaa valasikloviirihoidolla - pilottitutkimus vain valasikloviirilla.
    E.2.2Secondary objectives of the trial
    Effect may be especially clear among individuals with a APO E 4 genotype
    Vaikutus saattaa tulla erityisen selvästi esiin niillä potilailla, joilla on APOE 4-genotyyppi.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Finnish-speaking
    - Caregiver with the same address
    - Living in the Helsinki capital area or in the Oulu region
    - At least65 years of age
    - No terminal illness (life expectancy>1 year)
    - Stable AD (if ongoing AD medication, at least for 3 months)
    - MMSE-points >15
    - HSV-seropositive
    diagnosoidun Alzheimerin taudin lisäksi: suomenkielinen, läheinen/omainen asuu samassa osoitteessa tutkimuspaikan alueella, 65 vuotta täyttäneitä, ei terminaalivaiheen sairautta, stabiili Alzheimerin tauti (diagnoosista vähintään 6 kuukautta, jos lääkehoito, se vähintään 3 kuukauden ajan), MMSE-pisteet >15, HSV1-seropositiivinen (näyte otetaan 1. käynnillä).
    E.4Principal exclusion criteria
    - Allergy towardsvalaciclovir, or other reasons that would hinder takingthe trial medication regularly
    - Clinically significant interaction between valaciclovir and ongoing medication
    - Instable or severe clinical condition (cardiovascular disease, cancer)
    - Untreated depression
    - Prognosis < 1 year
    - Symptomsreducingadherence
    - Severe renal insufficiency (GFR <20, Cockgroft-Gault).
    yliherkkyys valasikloviirille tai ei pysty muusta syystä ottamaan tutkimuslääkettä säännöllisesti, kliinisesti merkittävä interaktio olemassa olevan lääkityksen kanssa (teofyllamiini), epästabiili tai vaikea kliininen tila (sydän- ja verisuonisairaudet, syöpä) ja elinajan odote alle 1 vuosi, hoitamaton depressio, muu etenevä keskushermoston sairaus, voimakas aivoverenkierron sairaus, hoitomyöntyvyyttä haittaavat käytösoireet, vaikea munuaisten vajaatoiminta (kreatiniinipuhdistuma <20 ml, Cockgroft-Gault kaavalla arvioituna).
    E.5 End points
    E.5.1Primary end point(s)
    Cognition 8( ADAS-cog) , function (ADCS-ADL) at 12 weeks
    Alzheimerpotilaan kognitio ( ADAS-cog) ja toimintakyky (ADCS-ADL) 12 viikon kohdalla
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 viikkoa
    E.5.2Secondary end point(s)
    Alzheimer patient: time at home or in institution, NPI, clock test, verbal fluency, CIBIC-plus. Use of health care for the dyad during 24 months. Side-effects. Cost-effectiveness, total mortality. RUD. Caregiver burden (RAND-36).
    Alzheimerpotilaan kotona vs. laitoshoidossa vietetty aika, NPI, kellotesti, verbal fluency, CIBIC-plus. , Intervention kustannusvaikuttavuus. Kokonaiskuolleisuus. Pitkäaikaishoitoon joutuminen. Sivuvaikutukset. Resurssien käyttö (RUD). Lähiomaisen kuormittuneisuus (elämänlaatu RAND-36-mittarilla).
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 viikkoa
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Pilot phase of a later randomised trial
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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
    12 weeks from start of trial
    12 viikkoa aloituksesta
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months3
    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: 30
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Alzheimer patients
    Alzheimerpotilaita
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    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)
    Normal clinical treatment
    tavaomainen potilashoito
    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 Decision2013-09-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-08-28
    P. End of Trial
    P.End of Trial StatusOngoing
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