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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   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).

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    Summary
    EudraCT Number:2014-003834-21
    Sponsor's Protocol Code Number:80-83600-98-10086
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-04-01
    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 number2014-003834-21
    A.3Full title of the trial
    Effectiveness of penfluridol (oral long acting neuroleptic) as compared to second generation oral neuroleptics in psychotic disorder patients: an open label randomized controlled trial.
    Effectiviteit van penfluridol (oraal lang-werkend neurolepticum) in vergelijking met orale tweede-generatie antipsychotica in patienten met een psychotische stoornis: een open label randomized controlled trial.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effectiveness of penfluridol (oral long acting neuroleptic) as compared to second generation oral neuroleptics in psychotic disorder patients: an open label randomized controlled trial.
    Effectiviteit van penfluridol (oraal lang-werkend neurolepticum) in vergelijking met orale tweede-generatie antispychotica in patienten met een psychotische stoornis: een open label randomized controlled trial.
    A.3.2Name or abbreviated title of the trial where available
    The One for Seven Study
    De One for Seven studie
    A.4.1Sponsor's protocol code number80-83600-98-10086
    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 SponsorErasmus Medical Center Rotterdam
    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 supportZonMw
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus Medical Center Rotterdam
    B.5.2Functional name of contact pointJanneke Gilden
    B.5.3 Address:
    B.5.3.1Street Address's Gravendijkwal 230
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3024 EB
    B.5.3.4CountryNetherlands
    B.5.6E-mailj.gilden@erasmusmc.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Zyprexa
    D.2.1.1.2Name of the Marketing Authorisation holderSandoz B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameolanzapine
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 risperidon
    D.2.1.1.2Name of the Marketing Authorisation holderSandoz B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 namerisperdal
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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.IMP: 3
    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 namepenfluridol
    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 INNpenfluridol
    D.3.9.1CAS number 26864-56-2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    Psychotic disorders
    Psychotische stoornissen
    E.1.1.1Medical condition in easily understood language
    Psychotic disorder
    Psychotische stoornissen
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    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
    The primary objective of this study is to determine the time to all-cause medication discontinuation of penfluridol (acemap; oral long acting neuroleptic) as compared to second-generation oral neuroleptics (olanzapine, risperidone) using an open label randomized controlled trial design in 180 patients.
    Het primaire doel van deze studie is om de tijd tot medicatie disconinuatie van penfluridol (acemap; oraal langwerkende neurolepticum) te bepalen, in vergelijking met de tweede generatie orale neuroleptica (olanzapine, risperidon) met behulp van een open-label gerandomiseerde gecontroleerde trial in 180 patiënten .
    E.2.2Secondary objectives of the trial
    Secondary objectives include the reason for treatment discontinuation, efficacy, safety and tolerability, drug attitude, subjective well-being, insight, healthcare related costs and quality of life.
    Secundaire doelen zijn het bepalen van de reden voor stopzetting van de behandeling, de werkzaamheid, veiligheid en verdraagbaarheid, houding ten opzichte van de medicatie, subjectief welzijn, inzicht, gezondheidszorg gerelateerde kosten en kwaliteit van leven.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be eligible to participate in this study, a subject must meet all of the following criteria:
    1. age 18-65 years
    2. psychotic disorder, including schizophrenia, schizoaffective disorder, delusional disorder or psychosis not otherwise specified
    3. treatment on an outpatient basis (at the start of the study)
    4. psychiatrist treating the patient decides that it is appropriate (based on clinical judgement, guidelines, history and symptoms of the patient) to prescribe either penfluridol, olanzapine or risperidone and that there a no decisive contra-indications
    5. patient is willing to use oral neuroleptic treatment, including penfluridol, olanzapine or risperidone
    6. able to give informed consent
    Om in aanmerking te komen voor deelname aan dit onderzoek, moet een patient voldoen aan alle van de volgende criteria:
    1 leeftijd 18-65 jaar
    2 psychotische stoornis, zoals schizofrenie, schizo-affectieve stoornis, waanstoornis of
    psychose niet anders gespecificeerd
    3. behandeling poliklinisch (aan het begin van de studie)
    4. behandelend psychiater van de patiënt besluit dat het passend (is gebaseerd op klinisch oordeel,
    richtlijnen, de geschiedenis en de symptomen van de patiënt) om voor te schrijven ofwel penfluridol, ofwel olanzapine of risperidon en hier geen contra-indicaties voor bestaan
    5. patiënt is bereid om orale neuroleptica te gebruiken, met inbegrip van penfluridol, olanzapine of risperidon
    6. patient moet informed consent kunnen geven
    E.4Principal exclusion criteria
    A potential subject who meets any of the following criteria will be excluded from participation in this study:
    1. judicial order stating that taking medication is obliged
    2. patient did use penfluridol during the previous six months
    3. serious and unstable medical condition
    4. insufficient proficiency in Dutch language
    5. women who are pregnant
    potentiële proefpersoon die aan één van de volgende criteria voldoet zal worden uitgesloten van deelname aan deze studie:
    1 rechterlijk bevel waarin wordt verklaard dat het nemen van medicatie is verplicht
    2. patient heeft in de afgelopen 6 maanden penfluridol gebruikt.
    3. ernstige en instabiele medische toestand
    4. onvoldoende beheersing van de Nederlandse taal
    5. vrouwen die zwanger zijn
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint of the study will be time to all-cause discontinuation, calculated from the date of randomization to the date of medication discontinuation according to the discontinuation definition.
    Primair eindpunt van de studie is medicatie discontinuatie, gerekend vanaf de datum van randomisatie tot de datum van discontinueren van de medicatie volgens de medicatie discontinuatie definitie.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 52 weeks
    Na 52 weken
    E.5.2Secondary end point(s)
    Secondary endpoints include the reason for treatment discontinuation, and relationship between efficacy, safety and tolerability, drug attitude, subjective well-being, insight and compliance, healthcare related costs and quality of life.
    Secundaire eindpunten omvatten de reden voor stopzetting van de behandeling, en de relatie tussen de werkzaamheid, veiligheid en verdraagbaarheid, drugs attitude, subjectieve welzijn, inzicht en compliance, gezondheidszorg gerelateerde kosten en kwaliteit van leven.













    Secundaire eindpunten omvatten de reden voor stopzetting van de behandeling, en de relatie tussen de werkzaamheid, veiligheid en verdraagbaarheid, drugs attitude, subjectieve welzijn, inzicht en compliance, gezondheidszorg gerelateerde kosten en kwaliteit van leven.












    Secundaire eindpunten omvatten de reden voor stopzetting van de behandeling, en de relatie tussen de werkzaamheid, veiligheid en verdraagbaarheid, houding ten opzichte van de medicatie, subjectief welzijn, inzicht en compliance, gezondheidszorg gerelateerde kosten en kwaliteit van leven.











    E.5.2.1Timepoint(s) of evaluation of this end point
    After 52 weeks
    Na 52 weken
    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) 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 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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned8
    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
    LVLS
    Laatste controle van laatst geincludeerde patient
    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 months0
    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) Yes
    F.1.2.1Number of subjects for this age range: 180
    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 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 state180
    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
    Geen
    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 Decision2015-04-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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