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    Summary
    EudraCT Number:2015-002520-82
    Sponsor's Protocol Code Number:CLO-MEAS
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-07-01
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2015-002520-82
    A.3Full title of the trial
    The significance of deviation in time from the 12-hour standard serum-clozapine monitoring
    Betydningen af afvigelser fra 12-timers blodprøvetidspunktet ved serum-clozapin monitorering
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The significance of deviation in time from the 12-hour standard serum-clozapine monitoring
    Betydningen af afvigelser fra 12-timers blodprøvetidspunktet ved serum-clozapin monitorering
    A.4.1Sponsor's protocol code numberCLO-MEAS
    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 SponsorProf., dr. med. Anders Fink-Jensen
    B.1.3.4CountryDenmark
    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 supportPsykiatrisk Center København
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPsykiatrisk Center København
    B.5.2Functional name of contact pointPsykiatrisk Afdeling O
    B.5.3 Address:
    B.5.3.1Street AddressEdel Sauntes Allé 10
    B.5.3.2Town/ cityKøbenhavn Ø
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.4Telephone number004538647072
    B.5.5Fax number004538647077
    B.5.6E-maila.fink-jensen@dadlnet.dk
    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 leponex
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Healthcare A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 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 INNClozapine
    D.3.9.1CAS number 5786-21-0
    D.3.9.3Other descriptive nameCLOZAPINE
    D.3.9.4EV Substance CodeSUB06787MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number25 to 100
    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
    Treatment-resistant schizophrenia
    Behandlingsresistent skizofreni
    E.1.1.1Medical condition in easily understood language
    Treatment-resistant schizophrenia i.e. schizophrenic patients who are non-responsive to, or intolerant of, other antipsychotic drugs.
    Behandlingsresistent skizofreni forstået som skizofrene patienter som ikke responderer på, eller ikke tolererer, andre antipsykotika
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10039642
    E.1.2Term Schizophrenic disorders
    E.1.2System Organ Class 100000004873
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the significance of deviation in time from the 12-hour standard blood sampling timepoint when Therapeutic Drug monitoring (TDM) clozapine
    At undersøge betydningen af at fravige tidspunktet for 12-timers målingen ved Therapeutic Drug Monitoring (TDM) af clozapin
    E.2.2Secondary objectives of the trial
    To describe changes of s-clozapine and s-N-desmethyl-clozapine within the range 10-14 hours after the last administration of clozapine .
    To describe what covariates that might affect the change of s-clozapine and s-N-desmethyl clozapine, including gender, age , BMI, co-medications, signs of infection, caffeine intake and smoking
    At beskrive ændringen af s-clozapin og s-N-desmethyl-clozapin indenfor intervallet 10-14 timer efter sidste clozapin administration.
    At beskrive hvilke kovariater der evt. påvirker ændringen af s-clozapin og s-N-desmethyl-clozapin, herunder køn, alder, BMI, medicin, infektionstegn, koffeinindtag og rygning
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age 18-65
    • Diagnosed with schizophrenia according to the criteria of ICD10 (International Classification of Diseases, World Health Organization) or the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, the American Psychiatric Association)
    • Unchanged dose of clozapine for the last 30 days
    • Usual time of administration of the clozapine evening-dose between 21:00 and 24:00
    • Alder 18-65 år
    • Diagnosticeret med skizofreni iht. ICD10 (International Classification of Diseases, World
    Health Organization) kriterierne eller DSM-IV (Diagnostic and Statistical Manual of Mental
    Disorders, Fourth Edition, the American Psychiatric Association)
    • Uændret dosis af clozapin gennem de sidste 30 dage
    • Vanlig administration af clozapin aftendosis mellem kl. 21:00 og 24:00
    E.4Principal exclusion criteria
    • Significant abuse that affects participation in this trial
    • Non- or partial compliance of clozapine the day before the trial (judged by interview)
    • can not be contacted by telephone the evening before the test
    • Has taken clozapine in the morning on the day of the trial
    • Significant change in smoking habits within the last 30 days ( rated at interview)
    • Significant change of caffeine intake within the last 7 days ( rated at interview)
    • Modified use of other antipsychotics within the last 30 days
    • Within the last 30 days (7 days for hormone based contraceptives) changed use of other medications that can affect s- clozapine during the trial :
    - medications that increases s-clozapine ( fluvoxamine, ciprofloxacin , hormone based contraceptives)
    - medications that lowers s-clozapine ( carbamazepine , phenytoin , rifampicin, omeprazole )
    • Females who are pregnant or breast-feeding
    • Signifikant misbrug, som påvirker deltagelsen i dette forsøg
    • Non- eller partiel compliance af clozapin dagen inden forsøget (bedømt ved interview)
    • kan ikke kontaktes telefonisk aftenen inden forsøget
    • Har taget clozapin om morgenen på forsøgsdagen
    • Markant ændring i rygevaner inden for de sidste 30 dage (bedømt ved interview)
    • Markant ændring af koffeinindtag inden for de sidste 7 dage (bedømt ved interview)
    • Ændret brug af andre antipsykotika inden for de sidste 30 dage
    • Inden for de sidste 30 dage (7 dage for hormonbaseret antikonception) ændret brug af anden medicin, som kan påvirke s-clozapin under forsøget:
    - Medicin, som øger s-clozapin (fluvoxamin, ciprofloxacin, p-piller og anden hormonbaseret antikonception)
    - Medicin, som sænker s-clozapin (carbamazepin, fenytoin, rifampicin, omeprazole)
    • Graviditet eller amning
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint is the relative change in s-clozapine and s-N-desmethyl clozapine over time , within the range of 10 to 14 hours after last clozapine administration.
    In addition the ratio between clozapine and N- desmethyl clozapine throughout the trial will be calculated.
    Primære endpoint er relativ ændring i s-clozapin og s-N-desmethyl-clozapin over tid, indenfor intervallet 10-14 timer efter sidste clozapin administration.
    I tillæg udregnes ratio mellem clozapin og N-desmethyl-clozapin igennem forsøget.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation takes place when inclusion has ended and after the simultaneous blood analysis
    Evaluering finder sted efter samlet blodprøveanalyse efter endt inklusion
    E.5.2Secondary end point(s)
    Subgroup analyzes will be performed in order to characterise any groups with particularly high or low risk of significant s-clozapine changes.
    Subgruppeanalyser vil blive foretaget med henblik på karakteristik af eventuelle grupper med særlig høj eller lav risiko for betydende s-clozapin-ændringer.
    E.5.2.1Timepoint(s) of evaluation of this end point
    When inclusion has ended
    Efter endt inklusion
    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 No
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    Evaluation of the s-clozapine monitoring regime
    Evaluering af s-clozapin monitorerings regimet
    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
    Eksplorativt
    Exploratory
    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.8.5The 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 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
    Sidste patients sidste besøg
    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 months7
    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) No
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Severe mental illness
    Svær psykiatrisk sygdom
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    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
    Ingen
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation GLP-1 projektet
    G.4.3.4Network Country Denmark
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-07-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-08-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-12-09
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