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    Summary
    EudraCT Number:2016-002859-19
    Sponsor's Protocol Code Number:072016
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-09-20
    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 number2016-002859-19
    A.3Full title of the trial
    Withdrawing off-label antipsychotics in people with intellectual disabilities: why does it fail?
    Antipsychotica afbouwen bij mensen met een verstandelijke beperking: waarom lukt het niet?
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Withdrawing off-label antipsychotics in people with intellectual disabilities: why does it fail?
    Antipsychotica afbouwen bij mensen met een verstandelijke beperking: waarom lukt het niet?
    A.4.1Sponsor's protocol code number072016
    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 MC
    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 supportAbrona
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportIpse de Bruggen
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportAmarant
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIpse de Bruggen
    B.5.2Functional name of contact pointDrs. J.G.A. van Hoek
    B.5.3 Address:
    B.5.3.1Street AddressLouis Braillelaan 42
    B.5.3.2Town/ cityZoetermeer
    B.5.3.3Post code2719 EK
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031889675020
    B.5.6E-mailjan.van.hoek@ipsedebruggen.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 Yes
    D.2.1.1.1Trade name Risperidone
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag 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 nameRisperidone
    D.3.4Pharmaceutical form Oral liquid
    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 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 Pipamperone
    D.2.1.1.2Name of the Marketing Authorisation holderEumedica N.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 namePipamperone
    D.3.4Pharmaceutical form Oral liquid
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral liquid
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral liquid
    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
    People with challenging behavior and off-label antipsychotic use
    Mensen met een verstandelijke beperking en gedragsproblemen waarvoor offlabel antipsychotica gebruik
    E.1.1.1Medical condition in easily understood language
    People with challenging behavior and off-label antipsychotic use
    Mensen met een verstandelijke beperking en gedragsproblemen waarvoor offlabel antipsychotica gebruik
    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
    To investigate why withdrawal of off-label antipsychotics for challenging behavior and intellectual disability is (often) not successful, by comparing two blinded groups of antipsychotic users of which only one is actually decreasing their AP.
    Onderzoeken waarom afbouw van off-label antipsychotica voor gedragsproblemen bij mensen met een verstandelijke beperking vaak niet succesvol verloopt door 2 geblindeerde groepen te vergelijken waarvan 1 het antipsychoticum daadwerkelijk afbouwt.
    E.2.2Secondary objectives of the trial
    To investigate patient characteristics that predict outcome of the withdrawal study.
    To evaluate whether in measuring drug induced movement disorders the use of electronic devices is superior to clinical rating scales.
    Onderzoeken of bepaalde patientkarakteristieken de uitkomst van de afbouw kunnen voorspellen.
    Onderzoeken of bewegingsstoornissen gemeten met speciale instrumenten beter zijn vergeleken met de klinische schalen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adults, >18 years
    Intellectual disability, IQ<70
    Living at one of the participating care-organisations
    Off-label use of risperidone or pipamperone because of challenging behavior > half year
    ZZP>3
    Volwassenen, leeftijd ≥ van 18 jaar
    Verstandelijke beperking, IQ < 70
    Woonachtig binnen een van de deelnemende zorgorganisaties (Abrona, Amarant, Ipse de Bruggen)
    Gebruik risperidon of pipamperon voor gedragsproblematiek langer dan een half jaar
    Zorgzwaartepakket inclusief behandeling (ZZP>3)
    E.4Principal exclusion criteria
    On-label antipsychotic use
    Active delirium <1 month
    Failed antipsychotic withdrawal last 6 months
    Use >1 antipsychotic
    On-label antipsychotica gebruik, dus met een juiste indicatie
    Actieve diagnose delier afgelopen maandag
    Een mislukte antipsychoticumafbouw afgelopen half jaar
    Gebruik van >1 antipsychoticum
    E.5 End points
    E.5.1Primary end point(s)
    Primary outcome measures are: interpretation of behavior, challening behavior, psychiatric disorders, circadiane rhythm problems, movement disorders and physical symptoms. They will be measured as follows:
    1. Challenging behavior:
    - Semi-structured interview
    - ABC
    - VAS
    - CGI
    2. Psychiatric disorders:
    - ADESS
    - PAS-ADD
    3. Circadiane rhythm problems:
    - Actigraphy
    - Somnography
    4. Movement disorders:
    - specific devices for measuring: dyskinesia, bradykinesia and akathisia
    - St. Hans Ratingscale and ARMS
    5. Withdrawal symptoms and side effects:
    - MEDS interview
    - Physical examination
    - Laboratory investigation
    De primaire uitkomstmaten zijn onder te verdelen in interpretatie van gedrag door betrokkenen/begeleiding, gedragsproblematiek, psychiatrische stoornissen, circadiaan ritme, bewegingsstoornissen en lichamelijke factoren. Ze worden gemeten worden met:
    1. Gedragsproblematiek:
    - Semi-gestructureerde interview
    - ABC/AGS
    - VAS
    - CGI
    2. Psychiatrische stoornissen:
    - ADESS
    - PAS-ADD
    3. Circadiaan ritme:
    - Actigrafie
    - Somnografie
    4. Bewegingsstoornissen:
    - specifieke meetinstrumenten (dyskinesie, bradykinesie en akathisie meter)
    - klinische scoringsinstrumenten: St. Hans Ratingscale en ARMS
    5. Afbouwverschijnselen/onttrekkingsverschijnselen en andere bekende bijwerkingen
    - MEDS interview
    - Lichamelijk onderzoek
    - Laboratorium onderzoek
    E.5.1.1Timepoint(s) of evaluation of this end point
    Most assessments will be performed at baseline and 2 and 4 weeks after each dose reduction and during follow-up (at 22 and 40 weeks). Some assessments (sleep with somnography and rating scales and electronic devices for diagnosing movement disorders) will be performed less frequently, to minimize the burden on patients.
    De meeste metingen zullen verricht worden op baseline en elke 2 en 4 weken na elke afbouwstap en gedurende de follow-up (week 22 en 40). Sommige metingen (somnografie en metingen van bewegingsstoornissen) zullen minder frequent worden verricht om de belasting van de patient te beperken.
    E.5.2Secondary end point(s)
    - CYP polymorphism
    - specific devices for measuring for dyskinesia, bradykinesia and akathisia VERSUS St. Hans Ratingscale and ARMS
    - physical examinations
    - CYP polymorphism
    - specific devices for measuring for dyskinesia, bradykinesia and akathisia VERSUS St. Hans Ratingscale and ARMS
    - physical examinations
    E.5.2.1Timepoint(s) of evaluation of this end point
    Most assessments will be performed at baseline and 2 and 4 weeks after each dose reduction and during follow-up (at 22 and 40 weeks). Some assessments (sleep with somnography and rating scales and electronic devices for diagnosing movement disorders) will be performed less frequently, to minimize the burden on patients.
    De meeste metingen zullen verricht worden op baseline en elke 2 en 4 weken na elke afbouwstap en gedurende de follow-up (week 22 en 40). Sommige metingen (somnografie en metingen van bewegingsstoornissen) zullen minder frequent worden verricht om de belasting van de patient te beperken.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    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 Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 concerned3
    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
    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 months9
    E.8.9.1In the Member State concerned days10
    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: 125
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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
    participants are adults with intellectual disability
    deelnemers zijn volwassenen met een verstandelijke beperking
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state126
    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 applicable
    niet van toepassing
    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 Decision2016-09-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-22
    P. End of Trial
    P.End of Trial StatusOngoing
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