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    Summary
    EudraCT Number:2014-003080-38
    Sponsor's Protocol Code Number:GOAT_1-2_1407
    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:2014-12-22
    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 ConcernedGermany - BfArM
    A.2EudraCT number2014-003080-38
    A.3Full title of the trial
    Glutamatergic medication in the treatment of

    Obsessive Compulsive Disorder (OCD) and
    Autism Spectrum Disorder (ASD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Glutamatergic medication in the treatment of

    Obsessive Compulsive Disorder (OCD) and
    Autism Spectrum Disorder (ASD)
    A.3.2Name or abbreviated title of the trial where available
    GOAT
    A.4.1Sponsor's protocol code numberGOAT_1-2_1407
    A.5.4Other Identifiers
    Name:TACTICS GOAT studyNumber:TACTICS GOAT
    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 Sponsor Radboud University Nijmegen Medical Centre, Donders Institute for Brain, Cognition and Behaviour
    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 supportEuropean Union
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCIMH, CAP, Medical Faculty Mannheim, University of Heidelberg
    B.5.2Functional name of contact pointwww.tactics-project.eu
    B.5.3 Address:
    B.5.3.1Street AddressJ5
    B.5.3.2Town/ cityMannheim
    B.5.3.3Post code68159
    B.5.3.4CountryGermany
    B.5.4Telephone number+4962117034532
    B.5.5Fax number+4962117034545
    B.5.6E-mailZI_AGKPPKJ@zi-mannheim.de
    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 Ebixa 5 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderH. Lundbeck A/S
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Film-coated 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 INNMEMANTINE HYDROCHLORIDE
    D.3.9.1CAS number 41100-52-1
    D.3.9.4EV Substance CodeSUB03137MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 Ebixa 10 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderH. Lundbeck A/S
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Film-coated 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 INNMEMANTINE HYDROCHLORIDE
    D.3.9.1CAS number 41100-52-1
    D.3.9.4EV Substance CodeSUB03137MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 placeboCapsule
    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 placeboCapsule
    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
    - Obsessive-compulsive disorder
    - Autistic Diorder, Aspergers' Disorder, PDD NOS
    E.1.1.1Medical condition in easily understood language
    patients with obsessive-compulsive disorder and 'autistic disorders' exhibiting compulsive symptoms will be studied
    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
    Primary objectives are:

    1) To investigate clinical effectiveness of the glutamatergic compound memantine in paediatric patients with:

    - Obessive-Compulsive Disorder (OCD) GOAT-1
    - Autism Spectrum Disorder (ASD) GOAT-2

    with respect to symptoms of
    - ‘compulsivity’ (assessed as CY-BOCs Total score) and/or

    2) To explore tolerability and safety (based on laboratory measures, adverse events) of the compound(s) in these clinical indications.

    E.2.2Secondary objectives of the trial
    Secondary objective(s) are:

    3) To explore the effects of glutamategic interventions at the level of the structure, function and biochemistry of the fronto-striatal circuits (MRI, MRS),
    in subgroups (disorders, age range, meeting inclusion/exclusion criteria of the COMPULS study
    protocol from the TACTICS project).
    4) To collect: blood for genetic analyses and biomarkers.
    5) To explore: additional clinical outcomes, disorder-specific (e.g., core symptoms, response rates,
    social functioning).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    General inclusion criteria for both patient groups (GOAT 1 – 2)

    • Male and female patients
    • Inpatient or outpatient status

    • Aged 6;0 y. (ASD patients) / 8;0 y. (OCD patients)- 17;9 years at initial inclusion
    • IQ > 70 (based on Wechsler scales, 4 subtests, cf. 5.1.3)
    • CGI-S score >/= 4 (moderately ill; anchored to respective disorder) at Baseline (BL, visit 3)
    • Ability to speak and comprehend the native language of the country in which the assessments take place
    • Signed informed consent by parents or legal representative
    • Signed informed assent by patients (indicating that the subject is aware of the investigational nature and the core aspects of the study and the study is run in accordance with the ICH GCP guideline E6 (1996))
    • Female subject must not have a positive beta HCG pregnancy test at screening, and must have a negative urine pregnancy test at baseline (BL), and agree to comply with applicable contraceptive requirements

    Inclusion criteria for subjects with OCD (GOAT-1)
    • DSM-5 diagnosis of OCD (APA, 2013), according to a systematic interview, e.g. DISC interview
    Inclusion criteria for subjects with ASD (GOAT-2)
    • DSM-5 diagnosis of ASD (APA, 2000), according to ADI-R interview (shortened version, focusing on criteria for diagnostic decision)
    E.4Principal exclusion criteria
    Patients/parents will not be excluded from the study(ies) in case they do not agree to participate in certain sets of assessments (e.g., neuroimaging, blood sampling for bioanalytic analyses).

    General exclusion criteria for all subject groups
    • Mental retardation (IQ < 70)
    • Body weight < 20kg at baseline (BL)
    • Major physical illness of the cardiovascular, endocrine, pulmonal, or the gastrointestinal system
    • Contra-indications for memantine, according to the Summary of Product characteristics (SPC)
    • History of or present clinically relevant somatic acute or chronic disorder that, in the opinion of the investigator, might confound the results of tolerability/safety assessment, or prohibit the patients from completing the study, or would not be in the best interest of the patient.
    • Subject has failed to respond, based on investigator judgement, to an earlier adequate course (dose and duration) of the investigational drug therapy, memantine.
    • Subject has a documented allergy, hypersensitivity, or intolerance to, memantine.
    • Subject has a positive urine drug screen result at screening or BL (apart from earlier prescribed medication; retest and negative result at BL needed then)
    • Subject has taken another investigational product or taken part in a clinical study with 30 days prior to screening
    • Subject is female and is pregnant or lactating


    • For those subjects intending to participate in the neuroimaging assessments: All contra indications for MRI assessment, such as the presence of metal objects in or around the body (pacemaker, dental braces)

    E.5 End points
    E.5.1Primary end point(s)
    The endpoints for the primary objective-1 are:

    outcome measures (Baseline-to-Endpoint change) of

    - compulsivity (CY-BOCS Total score (all patients)),

    The endpoints for the primary objective-2 are:
    - adverse event (AE) rates, derived from spontaneous reporting and a structured AE instrument,
    the (shortened/modified) Paediatric Adverse Event Rating Scale (PAERS).
    E.5.1.1Timepoint(s) of evaluation of this end point
    at: visits 3 - 10 each (BL - wk 12), unscheduled visits, and early discontinuation visit (cf. SOE in study protocol)
    E.5.2Secondary end point(s)
    The endpoints for the secondary objectives are:

    - Additional clinical outcomes, e.g. :

    - Response rates, response defined as

     >/= 30% reduction vs. BL on primary outcome scale (CY-BOCS Total score for OCD, ASD patients) plus
     CGI-I score of 1 (very much improved) or 2 (much improved).

    - Baseline-to-Endpoint changes in

     ABC Total score (ASD patients)

    - genotypes of single common and rare variants in candidate genes, and also combined genetic variants in whole genes or neurotransmitter systems / gene pathways;
    - further lab assessments of various proteins in blood plasma.
    E.5.2.1Timepoint(s) of evaluation of this end point
    at: visits 3 - 10 each (BL - wk 12), unscheduled visits, and early discontinuation visit (cf. SOE in study protocol);
    labs for genetics, biomarkers, once at BL (visit 3)
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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 Yes
    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 (in general)

    Possibility to stop the study early in case of severe safety/tolerability issues and/or (new) ethical concerns,
    after consultation with TACTICS consortium's steering committee and the independent scientivic Advisory Board/Data Monitoring Board.
    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
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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: 100
    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: 40
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 60
    F.1.2Adults (18-64 years) No
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2014-12-22. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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
    children and adolescents, by definition, from age 8 - 17;
    they will only be included when having given/signed 'informed assent'
    (cf. respective document)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    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)
    patients will be treated according to standard/routine clinical care at the investigational site or appropriate specialized physicians, clinics or hospitals (e.g., in child and adolescent psychiatry, paediatrics)
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation TACTICS (EU FP7 project) consortium
    G.4.3.4Network Country Netherlands
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-06-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-09-27
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