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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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:2005-001017-17
    Sponsor's Protocol Code Number:767
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2006-04-11
    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 number2005-001017-17
    A.3Full title of the trial
    µ-Opiatrezeptorvermittelte Dopaminfreisetzung bei Alkoholabhängigkeit:
    PET-Studien mit [18F]Fallypride
    A.4.1Sponsor's protocol code number767
    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 SponsorUniversity of Aachen
    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 Ultiva
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline
    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 nameUltiva
    D.3.4Pharmaceutical form Injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRemifentanil
    D.3.9.1CAS number 132539-07-2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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) 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 Information not present in EudraCT
    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 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 name[18F]Fallypride
    D.3.4Pharmaceutical form Injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive name[18F]Fallypride
    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 Yes
    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 Information not present in EudraCT
    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
    Beide Gruppen (15 Patienten und 15 Probanden) werden im Abstand von 7 Tagen einem PET-Scan mit [18F]Fallypride im Abstand von 7 Tagen unterzogen. Vor der 2. Injektion des Radiotracers wird den Probanden bzw. Patienten ein extrem kurzwirksamer (HWZ 5-10 min.) µ-Opiatrezeptor-Agonist (Remifentanil) intravenös injiziert. Eine Minute später wird der Radiotracer appliziert.
    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
    Mit der Untersuchung soll die Hypothese überprüft werden, dass Patienten mit einer Alkoholabhängigkeit im Vergleich zu gesunden Probanden auf einen opioidergen Stimulus eine gesteigerte Dopaminfreisetzung vor allem im ventralen Striatum aufweisen.
    E.2.2Secondary objectives of the trial
    Weiter wird hypostasiert, dass das Ausmaß der Steigerung der Dopaminfreisetzung auf einen opioidergen Stimulus positiv mit dem Alkoholverlangen zum Zeitpunkt der PET-Untersuchung und der Rückfallneigung korreliert.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Einschlusskriterien Probanden:
    • Alter zwischen 18 und 65 Jahren,
    • keine psychische Störung nach ICD 10 (F0 - F5) bzw. keine Achse I-Störung nach DSM IV,
    • mindestens 4-wöchige Medikamentenfreiheit (6monatige Freiheit von zentral wirksamen Substanzen) und 1-wöchige Alkoholkarenz.

    Einschlusskriterien Patienten:
    • Alter zwischen 18 und 65 Jahren,
    • die Kriterien für eine Alkoholabhängigkeit nach ICD 10 bzw. nach DSM IV sind erfüllt,
    • die Patienten müssen sich in einem Zustand der Einsichts- und Zustimmungsfä-higkeit befinden und nach Aufklärung eine schriftliche Einverständniserklärung abgeben,
    • die Patienten sollen über einen Zeitraum von mehr als sechs Wochen frei von jeder psychotropen Substanz sein. Ausgenommen sind Alkohol und Substanzen, mit denen die Alkoholentgiftung durchgeführt wird (nur Clomethiazol oder Benzo-diazepine). Diese dürfen mindestens zwei Wochen lang nicht mehr gegeben worden sein (langwirksame Benzodiazepine mit aktiven Metaboliten, z.B. Diaze-pam: vier Wochen).
    E.4Principal exclusion criteria
    Ausschlußkriterien:

    • Andere als die zugelassene Achse I-Diagnose nach ICD 10 bzw. DSM IV,
    • bei Probanden: Vorliegen einer psychischen Störung nach ICD 10 (F0 - F5) bzw. einer Achse I- bzw. Achse II-Störung nach DSM IV, insbesondere Alkohol- oder Drogenabhängigkeit bzw. missbrauch (Anamnese, Labor, Drogenscreening),
    • körperliche Erkrankungen, die nach Art und Schwere mit den geplanten Untersu-chungen interferieren, Einfluss auf die zu untersuchenden Parameter haben könnten oder den Patienten bzw. Probanden während des Untersuchungsablaufs gefährden könnten,
    • klinisch bedeutsame Abweichungen in der klinischen Chemie oder Hämatologie oder klinisch bedeutsame Auffälligkeiten im EKG oder im EEG,
    • Unfähigkeit, das Studienprotokoll einzuhalten,
    • Teilnahme an einer wissenschaftlichen Studie, bei der der Proband bzw. Patient ionisierender Strahlung ausgesetzt war, während der zurückliegenden zwölf Mo-nate,
    • stationärer Aufenthalt oder Behandlung auf nicht freiwilliger Basis,
    • beschränkte oder vollständig aufgehobene Geschäftsfähigkeit,
    • akute Suizidalität oder Fremdgefährdung,
    • die Unmöglichkeit der Durchführung einer MR-Untersuchung (z.B. Metall-Implantate, Schrittmacher, Klaustrophobie).
    E.5 End points
    E.5.1Primary end point(s)
    Endpunkt ist die durch einen Opiat-Agonisten hervorgerufene Dopaminfreisetzung, quantifiziert mit der PET.
    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 No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    Die Studie gilt als abgeschlossen, wenn alle 30 Versuchspersonen untersucht wurden. Abbruchkriterien sind nicht definiert.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    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 Yes
    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 Information not present in EudraCT
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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)
    Alle Probanden und Patienten werden für 2-3 Tage stationär aufgenommen und an beiden Untersuchungstagen detailliert psychopathologisch und neuropsychologisch untersucht. Die stationäre Aufnahme ermöglicht eine sorgfältige Nachbeobachtung. Nach der Untersuchung erfolgt über 6 Monate zunächst einmal wöchentlich, später in 14tägigen Abständen, ein Kontakt, in dem Psychopathologie und Craving erfaßt werden sollen.
    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 Decision2006-12-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusOngoing
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