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    Summary
    EudraCT Number:2020-005754-23
    Sponsor's Protocol Code Number:ASSTBS-FRADIO-SPA-2020
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-07
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-005754-23
    A.3Full title of the trial
    Stereotactic body radiation therapy on Prostate with or without Androgen deprivation therapy, a phase III randomized controlled trial (SPA Trial)
    RADIOTERAPIA STEREOTASSICA PROSTATICA CON O SENZA TERAPIA DI DEPRIVAZIONE ANDROGENICA, UNO STUDIO RANDOMIZZATO CONTROLLATO DI FASE III (TRIAL SPA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Stereotactic body radiation therapy on Prostate with or without Androgen deprivation therapy, a phase III randomized controlled trial (SPA Trial)
    RADIOTERAPIA STEREOTASSICA PROSTATICA CON O SENZA TERAPIA DI DEPRIVAZIONE ANDROGENICA, UNO STUDIO RANDOMIZZATO CONTROLLATO DI FASE III (TRIAL SPA)
    A.3.2Name or abbreviated title of the trial where available
    SPA TRIAL
    SPA TRIAL
    A.4.1Sponsor's protocol code numberASSTBS-FRADIO-SPA-2020
    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 SponsorAZIENDA SOCIO SANITARIA TERRITORIALE DEGLI SPEDALI CIVILI DI BRESCIA
    B.1.3.4CountryItaly
    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 supportIPSEN SPA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationasst degli spedali civili di Brescia
    B.5.2Functional name of contact pointprogettazione ricerca
    B.5.3 Address:
    B.5.3.1Street Addressp.le Spedali civili 1
    B.5.3.2Town/ citybrescia
    B.5.3.3Post code25123
    B.5.3.4CountryItaly
    B.5.4Telephone number0303998470
    B.5.5Fax number0303995671
    B.5.6E-mailcoordinamento.ricerca@asst-spedalicivili.it
    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 Decapeptyl
    D.2.1.1.2Name of the Marketing Authorisation holderIPSEN
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameDecapeptyl
    D.3.2Product code [Decapeptyl]
    D.3.4Pharmaceutical form Powder and solvent for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTRIPTORELINA
    D.3.9.2Current sponsor codeTriptorelina
    D.3.9.3Other descriptive nameTriptorelin
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number22
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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 CASODEX - 50 MG COMPRESSE RIVESTITE CON FILM 28 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderASTRAZENECA S.P.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 namecasodex
    D.3.2Product code [casodex]
    D.3.4Pharmaceutical form 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 INNBICALUTAMIDE
    D.3.9.2Current sponsor codebicalutamide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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 Yes
    D.3.11.13.1Other medicinal product typeAntiandrogeni
    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
    prostate acinar adenocarcinoma
    Pazienti adenocarcinoma acinare prostatico
    E.1.1.1Medical condition in easily understood language
    prostate acinar adenocarcinoma
    adenocarcinoma acinare della prostata
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10007453
    E.1.2Term Carcinoma of the prostate metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10001201
    E.1.2Term Adenocarcinoma of the prostate stage II
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10007456
    E.1.2Term Carcinoma of the prostate stage II
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10036951
    E.1.2Term Prostatic cancer stage II
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10036918
    E.1.2Term Prostate cancer stage II
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10001202
    E.1.2Term Adenocarcinoma of the prostate stage III
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10007457
    E.1.2Term Carcinoma of the prostate stage III
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10036952
    E.1.2Term Prostatic cancer stage III
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10036919
    E.1.2Term Prostate cancer stage III
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    to determinate if there is improvement in biochemical Disease Free Survival (bDFS) in patients treated with SBRT+ADT versus SBRT
    alone.
    Valutare un eventuale miglioramento della sopravvivenza libera da ripresa biochimica di malattia (bDFS) nei pz trattati con SBRT per il tumore della prostata + ADT (BRACCIO A) rispetto ai pz trattati solo con SBRT (BRACCIO B)
    E.2.2Secondary objectives of the trial
    disease free survival (DFS), freedom from local recurrence (FFLR), freedom from regional recurrence (FFRR) freedom from distant
    metastasis (FFDM), overall survival (OS) acute and late toxicity, quality of life (QoL)
    Dimostrare un eventuale miglioramento nel controllo locale e regionale del tumore, metastasi a distanza, sopravvivenza libera da malattia,
    sopravvivenza globale, tossicità acuta e tardiva e qualità della vita (QoL) nei pz trattati con SBRT + ADT rispetto ai pz trattati solo con SBRT
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age 18-80 years old.
    Histological confirmation of prostate acinar
    adenocarcinoma with a minimum of 10 biopsy cores taken
    Prostate protocol MRI for local staging
    Patients belonging to intermediate unfavorable group according to the D’Amico/NCCN risk group classification:
    o -Grade group 3 or/and
    o -2-3 risk factors for intermediate category (PSA 10-
    20 ng/ml/ Grade group 2-3/ cT2a cT2b) or/and
    o -biopsy cores positive >=50%
    Patients belonging to a subclass of high risk group according to the D’Amico/NCCN risk group classification:
    o -ISUP group 4 (GS 4+4, 3+5, 5+3) or
    o -cT3a stage or
    o PSA>20 ng/ml
    Eastern Coooperative Oncology Group (ECOG) PS 0-2
    Ability of the patient to understand and sign a written informed consent document
    Ability and Willingness to comply with patients reported outcome questionnaires schedule during the study time
    IPSS 0-15
    Prostate Volume less than 100cc
    PSA must be dosed maximum 60 days before randomization
    No pathologic lymph nodes and distant metastasis on PET (fluorocholine) scan or CT scan+bone scan.
    Età 18-80 anni.
    Conferma istologica di adenocarcinoma acinare prostatico con un minimo
    di 10 nuclei bioptici prelevati.
    RM con protocollo specifico per prostata con finalità di stadiazione locale
    Pazienti a rischio intermedio sfavorevole secondo la classificazione
    D’Amico / NCCN:
    Grado di gruppo 3 o / e
    2-3 fattori di rischio per la categoria intermedia (PSA 10-20 ng/ml / Grado
    gruppo 2-3 / cT2a cT2b) o / e
    nuclei (cores) bioptici positivi >=50%
    Pazienti appartenenti a una sottoclasse del gruppo ad alto rischio secondo
    la classificazione D’Amico/ NCCN:
    -ISUP 4 (GS 4 + 4, 3 + 5, 5 + 3) o
    -cT3a o
    PSA> 20 ng/ml
    Eastern Cooperative Oncology Group (ECOG) PS 0-2
    Capacità del paziente di comprendere e firmare un documento scritto di
    consenso informato
    Capacità e disponibilità a rispettare il programma dei questionari durante il
    periodo di studio e di follow-up
    IPSS 0-15
    Volume della prostata inferiore a 100 cc
    Dosaggio del PSA risalente a 60 giorni (o meno) rispetto alla data di
    randomizzazione
    Nessun linfonodo patologico e/o metastasi a distanza alla scansione PET
    (fluorocolina) o TC + scintigrafia ossea.
    E.4Principal exclusion criteria
    History of Malignant tumors in the previous 2 years excluding non melanoma cancers of the skin. If a patient presents an anamnesis of malignancy (excluding non melanoma skin cancers) it must be free from disease since 24 months at the time of enrollement.
    ¿ Previous prostate surgery other than TURP (at least 6 weeks prior to start of SBRT).
    ¿ Previous pelvic RT
    ¿ Prior androgen deprivation therapy (excluding 5alpha reductase inhibitors)
    ¿ Any prior active treatment for prostate cancer; patients on previous active surveillance areeligible if inclusion criteria are met
    ¿ Active severe inflammatory bowel disease
    ¿ Bilateral hip prothesis or any implant that could seriously interfere with dosimetric calculations
    ¿ Age >80 years.
    Storia di tumori maligni nei 2 anni precedenti esclusi i tumori della pelle non melanoma. Se il paziente presenta un'anamnesi di tumore maligno (esclusi i tumori cutanei non melanoma) deve essere libero da malattia da almeno 24 mesi al momento dell'arruolamento.
    • Precedente intervento chirurgico alla prostata diverso dalla TURP (che invece risulta accettabile se eseguita almeno 6 settimane prima dell'inizio dell'SBRT).
    • Precedente RT pelvica
    • Precedente terapia di deprivazione androgenica (esclusi gli inibitori della 5alfa
    reduttasi)
    • Qualsiasi precedente trattamento attivo per il cancro alla prostata; i pazienti sottoposti a precedente sorveglianza attiva sono eleggibili se sono soddisfatti i criteri di inclusione
    • Malattia infiammatoria intestinale grave attiva
    • Protesi bilaterale dell'anca o qualsiasi impianto che potrebbe interferire
    seriamente con i calcoli dosimetrici
    • Età> 80 anni.
    E.5 End points
    E.5.1Primary end point(s)
    To determinate if there is improvement in biochemical Disease free survival (bDFS, defined as
    PSA elevation = 2 ng/ml over Nadir, following the Phoenix criteria) in patients treated with
    prostate SBRT + ADT (ARM A) compared to patients treated with SBRT alone (ARM B).
    L’evento recidiva biochimica viene definito come aumento del PSA = 2 ng / ml su Nadir, seguendo i criteri di Phoenix
    E.5.1.1Timepoint(s) of evaluation of this end point
    -At baseline, 1, 3, 6, and 12 months following treatment and yearly thereafter the following will be recorded: IIEF-5 and IPSS
    -At baseline, 1, 3, 6, and 12 months following treatment the following will be recorded: EPIC-26, EORTC PR25
    Il PSA verrà registrato a 3, 6, 9 e 12 mesi dopo il trattamento, poi ogni 4 mesi fino all'anno 2, ogni 6 mesi dal terzo anno al quinto anno di FU.
    Il testosterone sarà registrato al basale, 6 mesi e 12 mesi dopo il trattamento in entrambi i bracci.
    E.5.2Secondary end point(s)
    Disease free survival (DFS, defined as evidence of biochemical, local, regional or distant relapse on imaging). Freedom from local recurrence (FFLR, defined as evidence of in-field recurrence detected at imaging and/or Histologically proved)
    Sopravvivenza libera da malattia (DFS, definita come evidenza di recidiva biochimica, locale, regionale o a distanza all'imaging).
    Sopravvivenza libera da ricaduta locale (FFLR, definita come evidenza di recidiva in campo di trattamento (in-field) rilevata all'imaging e/o provata istologicamente)
    E.5.2.1Timepoint(s) of evaluation of this end point
    3-5 years
    3-5 anni
    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 No
    E.6.5Efficacy No
    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) Yes
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    radioterapia
    stereotactic body radiation therapy
    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 concerned16
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    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 years8
    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 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: 110
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state310
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 310
    F.4.2.2In the whole clinical trial 310
    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 the national health system
    i pazienti saranno curati secondo il sistema sanitario nazionale
    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 Decision2021-04-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-16
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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