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    Summary
    EudraCT Number:2008-000584-42
    Sponsor's Protocol Code Number:FH1/08
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-04-14
    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 ConcernedGermany - BfArM
    A.2EudraCT number2008-000584-42
    A.3Full title of the trial
    Effekte von Zuclopenthixol auf aggressives Verhalten bei Kindern und Jugendlichen mit einer geistigen oder Lernbehinderung (unterdurchschnittlichen Intelligenz)
    A.4.1Sponsor's protocol code numberFH1/08
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversität Rostock, für diese handelnd Universitätsklinikum
    B.1.3.4CountryGermany
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Ciatyl-Z
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Vital GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameZuclopenthixol
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboCoated tablet
    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
    Aggressive Verhaltensstörungen bei intelligenzgeminderten Kindern und Jugendlichen
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10001490
    E.1.2Term Aggressive behaviour
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    gewichteter Score der Modified Overt Agression Scale (MOAS)
    E.2.2Secondary objectives of the trial
    - Child Behaviour Check List (CBCL 4-18, Elterfragebogen)
    - Disability Assessment Schedule (DAS), Sektion VII
    - Klinischer Gesamteindruck (Clinical Global Impression Scale - CGI)
    - Beobachtungen des Pflegepersonals (Nurse’s Observation Scale for Inpatient Evaluation – NOSIE)
    - KINDL – Fragebogen zur Lebensqualität
    - Fragebogen zur Behandlungsbeurteilung (FBB)
    - Gewicht – BMI
    - Prolaktinkonzentration im Serum
    - Serumspiegel von Zuclopenthixol
    - Lipidparameter
    - Compliance
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - unterdurchschnittliche Intelligenz (IQ 30 bis < 85)
    - männliches Geschlecht
    - Alter 8 bis 18 Jahre
    - aggressives Verhalten, DAS-Score Komplex VII < 40 und Summe der Items A, B, C und H </= 8 und der Items A und B </=4, CBCL/4-18 Elternfragebogen in den 19 Items einen T-Wert über 70, d.h. mit der dreistufigen Skalierung von 0 „nicht zutreffend“ bis 2 „genau oder häufig zutreffend“ ein Summenscore von 20 (bis 11 Jahre) oder 18 (12-18 Jahre), MOAS > 0.
    - Schriftliche Einwilligungserklärung der Eltern (Sorgeberechtige) und des Patienten
    - Aktuelles EKG, das einem Einschluss nicht entgegensteht
    E.4Principal exclusion criteria
    - Infantile Zerebralparese
    - Neurologische Erkrankungen (außer Epilepsie)
    - Psychosen
    - Lithium Behandlung
    - Teilnahme an dieser Studie zu einem früheren Zeitpunkt
    - Teilnahme an einer anderen Studie zur gleichen Zeit oder innerhalb der vergangenen 30 Tage
    - Notwendigkeit einer anderen als der erlaubten psychotropen Begleitmedikation (keine Veränderung während der Studie), erlaubt sind Antiepileptika in gleich bleibender Dosierung und Benzodiazepine zur antiepileptischen Notfallbehandlung sowie kurzzeitig Lorazepam, max. 5x für jeweils 3 Tage
    - Patienten mit aus der Krankengeschichte bekannten Allergie oder Empfindlichkeit gegen Zuclopenthixol
    - Gegenanzeigen von Zuclopenthixol wie akute Alkohol-, Schlafmittel-, Schmerzmittel- und Psychopharmakointoxikation, Kreislaufschock, Koma und Leistungsminderung des hämatopoetischen Systems
    E.5 End points
    E.5.1Primary end point(s)
    Ausmass an aggressiven Verhalten gem. der MOAS. Erfasst werden verbale Aggression, Aggression gegen Objekte, Autoaggression und Fremdaggression
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Diskontinuierunggsstudie (withdrawal design)l
    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.8.3 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 Information not present in EudraCT
    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
    Letze Visite des letzten Patienten
    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 months6
    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 Yes
    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.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    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
    Es handelt sich um intelligenzgeminderte/lernbehinderte (IQ 30-<85) Kinder und Jugendliche im Alter von 8.0 bis 17.11 Jahre. Die Einwilligung wird somit von den Betroffenen und ihren Eltern bzw. gesetzlichen Betreuern eingeholt.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state66
    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 Decision2008-08-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-08-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-07-05
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