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    Summary
    EudraCT Number:2013-005399-16
    Sponsor's Protocol Code Number:ROAC2014
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-06-09
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2013-005399-16
    A.3Full title of the trial
    Randomized, flexible-dose, open-label comparison to investigate the effectivenes of second generation antipsychotics in first episode psychosis patients.
    Estudio abierto randomizado a dosis flexibles de la efectividad de antipsicoticos de segunda generacion en el tratamiento de pacientes con un primer episodio de psicosis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effectivenes of second generation antipsychotics in first episode psychosis patients.
    Efectividad de antipsicoticos de segunda generacion en el tratamiento de pacientes con un primer episodio de psicosis.
    A.3.2Name or abbreviated title of the trial where available
    second generation antipsychotics in first episode psychosis patients
    A.4.1Sponsor's protocol code numberROAC2014
    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 SponsorDr. Benedicto Crespo. Servicio Psiquiatría. Hospital Universitario Marqués de Valdecilla/IDIVAL
    B.1.3.4CountrySpain
    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 supportIDIVAL / Hospital Universitario Marqués de Valdecilla
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Universitario Marqués de Valdecilla / IDIVAL
    B.5.2Functional name of contact pointBenedicto Crespo-Facorro
    B.5.3 Address:
    B.5.3.1Street AddressResidencia Cantabria.Planta 12. Unidad Investigacion Psiquiatria.Av Cardenal Herrera Oria s/n
    B.5.3.2Town/ citySantander
    B.5.3.3Post code39011
    B.5.3.4CountrySpain
    B.5.4Telephone number+34942202545
    B.5.5Fax number+34942203447
    B.5.6E-mailcrespob@unican.es
    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 ABILIFY
    D.2.1.1.2Name of the Marketing Authorisation holderLUNDBECK/OTSUKA
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 namearipiprazole
    D.3.2Product code aripiprazole
    D.3.4Pharmaceutical form Capsule, hard
    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 INNARIPIPRAZOLE
    D.3.9.1CAS number 129722-12-9
    D.3.9.2Current sponsor codeEU/1/04/276/036
    D.3.9.3Other descriptive nameARIPIPRAZOLE
    D.3.9.4EV Substance CodeSUB05564MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number10 to 30
    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 RISPERDAL
    D.2.1.1.2Name of the Marketing Authorisation holderJANSSEN CILAG
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.2Product code RISPERIDONE
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPBuccal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRISPERIDONE
    D.3.9.1CAS number 106266-06-2
    D.3.9.2Current sponsor code62.096
    D.3.9.3Other descriptive nameRISPERIDONE
    D.3.9.4EV Substance CodeSUB10335MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1 to 6
    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: 3
    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 ZYPREXA
    D.2.1.1.2Name of the Marketing Authorisation holderLILLY
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameOLANZAPINA
    D.3.2Product code OLANZAPINA
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPBuccal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOLANZAPINE
    D.3.9.1CAS number 132539-06-1
    D.3.9.2Current sponsor codeEU/1/96/022/022
    D.3.9.3Other descriptive nameOLANZAPINE
    D.3.9.4EV Substance CodeSUB09426MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number5 to 20
    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: 4
    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 LEPONEX
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS PHARMACEUTICAL
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameCLOZAPINA
    D.3.2Product code CLOZAPINA
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPBuccal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCLOZAPINE
    D.3.9.1CAS number 5786-21-0
    D.3.9.2Current sponsor code59.547
    D.3.9.3Other descriptive nameCLOZAPINE
    D.3.9.4EV Substance CodeSUB06787MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number100 to 500
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    FIRST EPISODE DRUG-NAÏVE OF PSYCHOSIS (SCHIZOPHRENIA SPECTRUM DISORDERS)
    PRIMER EPISODIO DE PSICOSIS (ESPECTRO DE ESQUIZOFRENIA) SIN MEDICACION
    E.1.1.1Medical condition in easily understood language
    PACIENTS WITH A FIRST EPISODE OF PSYCHOSIS WITHOUT AFFECTIVE SYMPTOMS WHO HAVE NEVER RECEIVED ANTIPSYCHOTIC TREATMENT BEFORE
    PACIENTES CON UN PRIMER EPISODIO DE PSICOSIS (ESPECTRO DE ESQUIZOFRENIA) QUE NUNCA HAN RECIBIDO TRATAMIENTO FARMACOLOGICO ANTES
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level HLGT
    E.1.2Classification code 10039628
    E.1.2Term Schizophrenia and other psychotic disorders
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    TO HEAD-TO-HEAD COMPARE THE CLINICAL EFFECTIVENESS OF ARIPIPRAZOLE AND RISPERIDONE IN TREATING PATIENTS WITH A FIRST EPISODE OF NON-AFFECTIVE PSYCHOSIS.
    COMPARAR DIRECTAMENTE LA EFECTIVIDAD CLINICA DE ARIPIPRAZOL Y RISPERIDONA EN EL TRATAMIENTO DE PACIENTES CON UN PRIMER EPISODIO DE PSICOSIS
    E.2.2Secondary objectives of the trial
    TO EVALUATE DIFFERENCES IN SIDE EFFECTS PROFILE BETWEEN TREATMENTS
    TO EVALUATE DIFFERENCES IN COGNITIVE EFFICACY BETWEEN TREATMENTS
    TO ASSESS DIFFERENCES IN FUNCTIONAL RECOVERY BETWEEN TREATMENTS
    COMPARAR LAS DIFERENCIAS ENTRE FARMACOS EN PERFIL DE EFECTOS SECUNDARIOS
    COMPARAR LAS DIFERENCIAS ENTRE FARMACOS EN EFICACIA COGNITIVA
    COMPARAR LAS DIFERENCIAS ENTRE FARMACOS EN RECUPERACION FUNCIONAL
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    From May 2014 to May 2016 all referrals to PAFIP were screened for patients who met the following criteria: 1) 15-60 years; 2) living in the catchment area; 3) experiencing their first episode of psychosis; 4) no prior treatment with antipsychotic medication or, if previously treated, a total life time of adequate antipsychotic treatment of less than 6 weeks; 5) DSM-IV criteria for brief psychotic disorder, schizophreniform disorder, schizophrenia, or schizoaffective disorder. The diagnoses were confirmed using the Structured Clinical Interview for DSM-IV (SCID ?I) (First et al., 2001) carried out by an experienced psychiatrist 6 months on from the baseline visit. Our operational definition for a ?first episode of psychosis? included individuals with a non-affective psychosis (meeting the inclusion criteria defined above) who have not received previously antipsychotic treatment regardless the duration of psychosis.
    E.4Principal exclusion criteria
    Patients were excluded for any of the following reasons: 1) meeting DSM-IV criteria for drug dependence, 2) meeting DSM-IV criteria for mental retardation, 3) having a history of neurological disease or head injury.
    E.5 End points
    E.5.1Primary end point(s)
    THE PRIMARY END POINT WILL BE A 30% OF REDUCTION OF TOTAL SCORE OF BRIEF PSYCHIATRIC RATING SCALE (COMPARED TO BASELINE).
    EL PRIMER PUNTO DE FINALIZACION SERA UN 30% DE REDUCCION EN LA PUNTUACION TOTAL DEL BPRS (DIFERENCIA CON EL VALOR BASAL)
    E.5.1.1Timepoint(s) of evaluation of this end point
    AT 3 WEEKS
    A LAS 3 SEMANAS.
    E.5.2Secondary end point(s)
    THE PRIMARY END POINT WILL BE A 30% OF REDUCTION OF TOTAL SCORE OF BRIEF PSYCHIATRIC RATING SCALE (COMPARED TO BASELINE).
    EL PRIMER PUNTO DE FINALIZACION SERA UN 30% DE REDUCCION EN LA PUNTUACION TOTAL DEL BPRS (DIFERENCIA CON EL VALOR BASAL)
    E.5.2.1Timepoint(s) of evaluation of this end point
    AT 6 WEEKS
    A LAS 6 SEMANAS
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    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.8.5The 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
    Definition of the end of the trial: THE TRIAL WILL BE ENDED WHEN THE NUMBER OF 100 PATIENTS ALLOCATED IN EACH ARM WILL BE REACHED.

    IN CASE THAT THE LAST SUBJECT UNDERGOING THE TRIAL DROPS OUT THE STUDY THE STUDY WILL BE CONCLUDED AT THE SAME DATE THE PATIENTS IS DROPPED OUT.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    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 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: 200
    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 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
    DUE TO ACUTE CLINICAL SYMPTOMS ENCOMPASSING A LACK OF ILLNESS INSIGHT AN DTHE NEED OF TREATMENT, INITIALLY CLOSE RELATIVES WILL PROVIDE INFORMED WRITTEN CONSENT IF NEEDED
    DEBIDO A LA SITUACION FRECEUNTE DE UN AFALT ADE INSIGHT ED ENFEREMDAD Y DE NECESIDAD DE TRATAMIENTIO FARMACOLOGICO EN ALGUNOS CASOS SE RECOGERA INICIALMENTE EL CONSENTIMIENTO INFORMADO POR ESCRITO A FAMILIARES CERCANOS.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 200
    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)
    Standard medical care
    Tratamiento médico habitual
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-08-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-25
    P. End of Trial
    P.End of Trial StatusOngoing
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