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    Summary
    EudraCT Number:2014-003718-10
    Sponsor's Protocol Code Number:2014RISP-ID01
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-09-09
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2014-003718-10
    A.3Full title of the trial
    A placebo-controlled discontinuation trial of off-label used risperidone in people with intellectual disability
    Een placebo-gecontroleerde afbouwstudie naar off-label risperidon gebruik door mensen met een verstandelijke beperking
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    off-label use of risperidone in people with intellectual disability: A discontinuation study
    Off-label gebruik van risperidon door mensen met een verstandelijke beperking: een afbouwstudie
    A.3.2Name or abbreviated title of the trial where available
    Discontinuation of risperidone in people with intellectual disability
    A.4.1Sponsor's protocol code number2014RISP-ID01
    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 SponsorUMCG
    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.4.1Name of organisation providing supportHet Zorgondersteuningsfonds
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUMCG
    B.5.2Functional name of contact pointRisperidone ID trial information
    B.5.3 Address:
    B.5.3.1Street AddressPostbus 30.001
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9700RB
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031592334100
    B.5.6E-maillotte.ramerman@ggzdrenthe.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 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 nameRisperidone
    D.3.4Pharmaceutical form Oral solution
    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 INNrisperidone
    D.3.9.3Other descriptive nameRISPERIDONE
    D.3.9.4EV Substance CodeSUB10335MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 solution
    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
    no specific condition, we will investigate people with intellectual disability who have been using risperidone on an off-label basis for at least one year.
    E.1.1.1Medical condition in easily understood language
    no specific condition, we will investigate people with intellectual disability who have been using risperidone on an off-label basis for at least one year.
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]
    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 study the effect of controlled discontinuation of long-term used risperidone, for the treatment of challenging behavior, on behaviour and health. Our hypothesis is that long-term use of risperidone for challenging behaviour is not more effective than a placebo.
    E.2.2Secondary objectives of the trial
    1) To study the effect of controlled discontinuation on physical health parameters, including physical parameters of side-effects.
    2) To study the effect of controlled discontinuation of risperidone on Health-related Quality of Life (HQoL).
    3) To study whether there is an association between HQoL and severity of challenging behaviour and physical health parameters.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. IQ<70 as assessed by an authorized behavioral therapist
    2. Age > 6 years
    3. No history of chronic psychosis
    4. Risperidone use>1 year
    5. Challenging behavior was the reason of prescription of risperidone
    6. Informed consent obtained from legal representative
    E.4Principal exclusion criteria
    1. A history of schizofrenia, a bipolar disorder, or affective psychosis according to DSM IV or ICD-10 criteria
    2. A history of unsuccessful withdrawal of antipsychotics in the past 6 months
    3. The use of other antipsychotics in addition to risperidone use
    4. Risperidone is administered as long-acting injections
    5. Clients that do not receive 24 hour/a day care (by either a service provider or parents/family)
    E.5 End points
    E.5.1Primary end point(s)
    The primary end point is behaviopr meassured by the irritability subscale of the Aberrant Behaviour Checklist (ABC). The ABC was developed to assess (pharmaceutical) treatment effects on the challenging behaviors of people with intellectual disability (35-37). The ABC has 58 items divided over five subscales i.e., irritability (15 items), lethargy (16 items), stereotypic behavior (7 items), hyperactivity (16 items) and inappropriate speech (4 items).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, week 6, 10, 14, 18, blinded follow-up at week 24 and natural follow-up at week 42.
    E.5.2Secondary end point(s)
    - Other ABC subscales
    - Clinical Global Impression Scale (CGI)
    - Abnormal Involuntary Movement Scale (AIMS)
    - Barnes Akathisia Rating Scale (BARS)
    - Unified Parkinsons Disease Rating Scale (UPDRS)
    - Scales for Outcomes in Parkinson’s disease AUTonomic symptoms (SCOPA-AUT)
    - Epworth Sleepiness Scale (ESS)
    - Personal Outcome Scale (POS)
    - RAND-36
    - Physical measures: length, weight, waist circumference, heart rate and blood pressure
    - Blood counts

    From a blood draw, we will obtain measures on:
    •Metabolism: fasting glucose, insulin, triglycerides, high-density
    lipoproteins (HDL), low-density lipoproteins (LDL), leptine, total
    cholesterol, and HbA1C.
    •Endocrine parameters: prolactin, testosterone
    •Bone turnover: P1NP, CTx, osteocalcine, BAF, vitamin D, and calcium.
    •Thyroid function: TSH, T4, and parathyreoid hormone.
    •Pharmacokinetics: risperidone and 9-hydroxyrisperidone
    concentrations.
    •Albumine, creatine, potasium and sodium levels.
    Predictor variables:
    - Demographic data and socio-economic status
    - Treatment history and psychiatric diagnosis
    - Tanner stages of pubertal development
    - Challenging Behavior Self-Efficacy Scale
    - the Emotional Reactions to Challenging Behavior Scale
    - knowledge of psychotropic drugs
    - beliefs of caregivers
    E.5.2.1Timepoint(s) of evaluation of this end point
    All questionnaires (excl POS and RAND-36): Baseline, week 6, 10, 14, 18, blinded follow-up at week 24 and natural follow-up at week 42.

    POS and RAND-36: Baseline, week 10, 18, blinded follow-up at week 24 and natural follow-up at week 42.

    Blood counts: Baseline, 18, blinded follow-up at week 24

    predictor variables: Baseline
    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 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 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 concerned5
    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
    The end of the study is defined as the last subject last visit. The study will be terminated prematurely when in line with the revised CCMO Directive on the Assessment of Clinical Trial Agreements.
    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 days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 20
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 10
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 10
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 95
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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
    People with intellectual disability with an IQ below 70. Most people with have a legal representative.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state120
    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. Treatment with risperidon is allowed to continue or discontinue after the end of the trial.
    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 Decision2015-09-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-08-26
    P. End of Trial
    P.End of Trial StatusCompleted
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