Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2010-024270-19
    Sponsor's Protocol Code Number:CCD-1014-PR-0053
    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:2011-09-02
    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 number2010-024270-19
    A.3Full title of the trial
    A Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Tolerability of Multiple Dose Regimens of CHF 5074 (200, 400, 600 mg/day for up to 12 Weeks) and to Explore the Effects on Potential Markers of Clinical Efficacy in Patients with Mild Cognitive Impairment
    A Randomized , Placebo-Controlled, Multicenter Study to Evaluate the Safety and Tolerability of Multiple Dose Regimens of CHF 5074 (200, 400, 600 mg/day for up to 12 Weeks) and to Explore the Effects on Potential Markers of Clinical Efficacy in Patients with Mild Cognitive Impairment.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A random distribution of trattaments, which one Placebo, Multicenter Study to Evaluate the Safety and Tolerability of Multiple Dose Regimens of CHF 5074 drug (200, 400, 600 mg/day for up to 12 Weeks) and to Explore the Effects on blood indicators of Clinical Efficacy in Patients with Mild Cognitive Impairment
    Studio multicentrico, a distribuzione casuale dei trattamenti uno dei quali placebo, per valutare la sicurezza e la tollerabilita' di somministrazioni multiple del farmaco CHF 5074 (200, 400, 600 mg al giorno per un periodo di 12 settimane di trattamento) e per esplorare gli effetti su possibili indicatori ematici di efficacia clinica in pazienti con deficit cognitivo lieve
    A.3.2Name or abbreviated title of the trial where available
    ND
    ND
    A.4.1Sponsor's protocol code numberCCD-1014-PR-0053
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01303744
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1120-2339
    A.5.4Other Identifiers
    Name:NDNumber:ND
    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 SponsorCHIESI
    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 supportChiesi Pharmaceuticals Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCROM
    B.5.2Functional name of contact pointClinical Research Unit 1
    B.5.3 Address:
    B.5.3.1Street AddressVia scuderlando 10
    B.5.3.2Town/ cityVerona
    B.5.3.3Post code37135
    B.5.3.4CountryItaly
    B.5.4Telephone number045 8222811
    B.5.5Fax number045 8222812
    B.5.6E-mailMCIcromteam@cromgroup.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 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 nameCHF 5074
    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 INNOther nervous system drugs
    D.3.9.1CAS number 749269-83-8
    D.3.9.2Current sponsor codeCHF 5074
    D.3.9.4EV Substance CodePRD209243
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 placeboTablet
    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
    Mild Cognitive Impairment
    Deficit cognitivo lieve
    E.1.1.1Medical condition in easily understood language
    Mild impairment of the cognitive system
    Lieve compromissione del sistema cognitivo
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level SOC
    E.1.2Classification code 10029205
    E.1.2Term Nervous system disorders
    E.1.2System Organ Class 10029205 - Nervous system 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 tolerability of ascending oral doses (200, 400, or 600 mg/day) of CHF 5074 administered once per day for up to 12 weeks to patients with mild cognitive impairment
    Valutare la sicurezza e tollerabilita' di dosi orali crescenti (200, 400 o 600 mg/die) di CHF 5074 somministrate una volta al giorno per un periodo di 12 settimane a pazienti con deficit cognitivo lieve
    E.2.2Secondary objectives of the trial
    The secondary objective of this study is to evaluate the pharmacokinetics of CHF 5074 in patients with mild cognitive impairment.
    L'obbiettivo secondario di questo studio e' valutare la farmacocinetica del CHF 5074 in pazienti con deficit cognitivo lieve.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient’s written informed consent is obtained prior to any study-related procedures. 2. Patient is younger than 80 years of age. 3. Patient has a diagnosis of amnestic or non-amnestic Mild Cognitive Impairment according to modified Petersen, et al`s criteria. 4. Patient has a Mini-Mental State Examination (MMSE) score higher than 24 at screening. 5. MRI scan of the brain at screening with fluid-attenuation inversion recovery (FLAIR) and T2*-weighted gradient-recalled-echo (GRE) sequences. 6. Patient’s informant is available.
    1. Il consenso informato del paziente e' stato ottenuto per iscritto prima di qualsiasi procedura relativa allo studio. 2. Il paziente e' di eta' inferiore a 80 anni. 3. Il paziente ha una diagnosi di deficit cognitivo lieve amnesico o non amnesico in base ai criteri modificati di Petersen et al. 4. Il paziente ha un punteggio superiore a 24 nel Mini-Mental State Examination (MMSE). 5. Risonanza magnetica del cervello allo screening con le sequenze FLAIR (Fluid-attenuated Inversion Recovery) e GRE (Gradient-recalled-echo) pesate in T2*. 6. Disponibilita' di una persona a dare informazioni sul paziente
    E.4Principal exclusion criteria
    A diagnosis of Alzheimer’s disease according to the Diagnostic and Statistical Manual of Mental Disorders 4th Edition Text Revision (DSM-IV-TR) or National Institute of Neurological and Communicative Disorders and Stroke-AD and Related Disorders (NINCDS-ADRDA) criteria. 2. Any medical condition that could explain the patients cognitive deficits CT or MRI brain imaging results obtained within 12-months prior to baseline showing evidence of infection, infarction, or focal lesions of clinical significance. 4. MRI scan at screening showing more than 4 cerebral microhemorrhages (lesions with diameter ≤ 10 mm), regardless of their anatomical location or diagnostic characterization as `possible` or “definite`. 5. MRI scan at screening showing single area of superficial siderosis, or evidence of a prior macrohemorrhage (lesion with diameter > 10 mm). 6. A Geriatric Depression Scale (30-point scale) score > 9 at screening. 7. History of stroke. Patients with a history of transient ischemic attack may be enrolled, if occurred at least three months prior to screening. 8. A modified Hachinski ischemic scale score > 4 at screening. 9. Women of childbearing potential. Women of childbearing potential include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal. 10. Women who are breastfeeding or pregnant. 11. Women with a positive pregnancy test within 72 hours prior to administration of first dose of study medication. 12. Sexually active fertile men not using effective birth control if their partners are women of childbearing potential. 13. Patient has vitamin B12 or folate deficiency. Patients with a B12 deficiency may participate in the study if they are on stable vitamin B12 replacement for at least three months prior to screening. 14. All skin cancers and any cancer that is being actively treated, as well as a history of cancers that are considered to have a high probability of recurrence (with supporting documentation of this from the treating oncologist, if necessary). 15. Clinically significant abnormal coagulations tests. 16. Unstable cardiovascular (includes uncontrolled hypertension), pulmonary, gastrointestinal or hepatic disease one month prior to screening. 17. Diagnosis of schizophrenia or recurrent mood disorder (including unipolar and bipolar disorders) within 3 years of screening. 18. Current diagnosis of peptic ulcer or gastrointestinal bleeding within the last year and/or chronic inflammatory bowel disease. 19. History of neurosyphilis as indicated by positive fluorescent treponemal antibody absorption (FTA-ABS), or microhemagglutination assay (MHA-TP), or treponema pallidum particle agglutination assay (TPPA) tests. 20. Concomitant use of donepezil at doses > 5 mg/day or other cholinesterase inhibitors (rivastigmine or galantamine) at any dose. 21. Concomitant use of memantine at doses > 20 mg/day. 22. Concomitant use of psychoactive drugs (sedatives, hypnotics, etc.). Stable doses of sedatives for conditions such as mild to moderate anxiety or insomnia may be permitted if they have been stable for at least 30 days prior to randomization.
    1.Una diagnosi di morbo di Alzheimer secondo il Manuale diagnostico e statistico dei disturbi mentali IV edizione, revisione del testo (DSM-IV-TR) o i criteri del NINCDS-ADRD. 2.Qualsiasi condizione medica che possa spiegare i deficit cognitivi del paziente 3.Risultati di diagnostica per immagini (TAC o RM) ottenuti nei 12 mesi precedenti la visita basale indicanti evidenza di infezione, infarto o lesioni focali clinicamente significative. 4. RM allo screening indicante piu` di 4 microemorragie cerebrali indipendentemente dalla loro localizzazione anatomica o caratterizzazione diagnostica come `possibili` o `accertate`(lesioni con diametro superiore a 10 mm). 5. RM allo screening indicante singola area di siderosi superficiale o evidenza di precedente macroemorragia (lesioni con diametro superiore a 10 mm).. 6. Punteggio &gt; 9 nella Geriatric Depression Scale (scala a 30 punti) allo screening. 7. Anamnesi di ictus. Si possono arruolare pazienti con anamnesi di attacco ischemico transitorio se si e` verificato almeno tre mesi prima dello screening. 8. Punteggio &gt; 4 nella scala ischemica di Hachinski modificata. 9. Donne potenzialmente fertili. Per donne potenzialmente fertili si intendono donne che hanno raggiunto il menarca e non hanno subito interventi di sterilizzazione chirurgica (isterectomia, legatura bilaterale delle tube oppure ooforectomia bilaterale) o non sono in menopausa. 10. Donne in allattamento o gravidanza. 11. Donne con un risultato positivo al test di gravidanza nelle 72 ore de precedenti la somministrazione della prima dose del farmaco in studio. 12. Uomini fertili e sessualmente attivi che non usano metodi efficaci di contraccezione se le loro partner sono donne potenzialmente fertili. 13. Pazienti con carenza di vitamina B12 o di acido folico. I pazienti con carenza di B12 possono partecipare allo studio se assumono stabilmente integratori di vitamina B12 da almeno tre mesi prima dello screening. 14. Qualsiasi tipo di cancro della pelle e qualsiasi cancro che sia in trattamento attivo,cosi` come una precedente storia clinica di qualsiasi cancro la cui probabilita` di recidiva sia ritenuta alta (con documentazione a supporto fornita dall`oncologo che ha in cura il paziente, se necessario). 15. Anomalie clinicamente significative nei test di coagulazione. 16. Malattia cardiovascolare instabile (inclusa ipertensione non controllata), malattia polmonare, gastrointestinale o epatica nel mese precedente lo screening. 17. Diagnosi di schizofrenia o disturbo dell`umore ricorrente (inclusi disturbi unipolari e bipolari) entro 3 anni dallo screening. 18. Attuale diagnosi di ulcera peptica o sanguinamento gastrointestinale nel corso dell`ultimo anno e/o malattia infiammatoria cronica intestinale. 19. Anamnesi di neurosifilide come indicato da positivita` al test di assorbimento (FTA-ABS) o di microemoagglutinazione (MHA-TP) degli anticorpi contro Treponema fluorescenti, o al test di agglutinazione di particelle di Treponema Pallidum (TPPA) . 20. Uso concomitante di donepezil a dosi &gt; 5 mg/die o altri inibitori delle colinesterasi (rivastigmina o galantamina) a qualsiasi dosaggio. 21. Uso concomitante di memantina a dosi &gt; 20 mg/die. 22. Uso concomitante di farmaci psicoattivi (sedativi, ipnotici, ecc.) Dosi stabili di sedativi per condizioni quali ansia o insonnia da lieve a moderata potrebbero essere consentite se stabili da almeno 30 giorni prima della randomizzazione.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is to determine the maximum tolerated dose (MTD) of CHF 5074 after multiple oral once-daily administrations (up to 12 weeks) to patients with mild cognitive impairment. The MTD of CHF 5074 is defined as the highest dose of the drug that does not, in the opinion of the Data Safety and Monitoring Board (DSMB), cause an intolerable adverse event that is related or possibly related to CHF 5074.
    L'endpoint primario dello studio e' determinare la massima dose tollerabile (MTD) di CHF 5074 dopo somministrazioni multiple per via orale una volta al giorno (per 12 settimane)in pazienti con deficit cognitivo lieve. La MTD del CHF 5074 e' definita come la dose massima di farmaco che, secondo il Data Safety e il Monitoring Board (DSMB), non causa eventi avversi intollerabili correlati o presumibilmente correlati con il CHF 5074.
    E.5.1.1Timepoint(s) of evaluation of this end point
    16 month
    16 mesi
    E.5.2Secondary end point(s)
    The secondary objective of this study is to evaluate the pharmacokinetics of CHF 5074 in patients with mild cognitive impairment
    L`endpoint secondario è di valutare la farmacocinetica del CHF 5074 in pazienti con deficit cognitivo lieve
    E.5.2.1Timepoint(s) of evaluation of this end point
    16 month
    16 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 Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Information not present in EudraCT
    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.8.2.3.1Comparator description
    Placebo nella stessa forma del farmaco in studio
    Placebo in the same form of study drug
    E.8.2.4Number of treatment arms in the trial2
    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 concerned13
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA13
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    E.8.7Trial has a data monitoring committee Yes
    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 months16
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months16
    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 Information not present in EudraCT
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 46
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state83
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 83
    F.4.2.2In the whole clinical trial 96
    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)
    not aplicable
    non applicabile
    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 Decision2011-05-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-08
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 19 21:30:01 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA