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    The EU Clinical Trials Register currently displays   41472   clinical trials with a EudraCT protocol, of which   6816   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2011-002640-27
    Sponsor's Protocol Code Number:GED-301-01-11
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-02-09
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-002640-27
    A.3Full title of the trial
    A phase II multicenter, randomized, double-blind, controlled vs placebo, dose-finding study on the efficacy and safety of GED-0301, in patients with active Crohn‟s disease (Ileo-Colitis)
    Studio multicentrico di fase II, randomizzato, in doppio cieco, per la determinazione della dose efficace, controllato vs placebo sull'efficacia, la sicurezza di GED-0301, in pazienti con Morbo di Crohn in fase attiva (Ileo-Colite)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase II multicenter, randomized, double-blind, controlled vs placebo, dose-finding study on the efficacy and safety of GED-0301, in patients with active Crohn’s disease (Ileo-Colitis)
    Studio multicentrico di fase II, randomizzato, in doppio cieco, per la determinazione della dose efficace, controllato vs placebo sull’efficacia, la sicurezza di GED-0301, in pazienti con Morbo di Crohn in fase attiva (Ileo-Colite)
    A.3.2Name or abbreviated title of the trial where available
    I.G.O.N. 1 STUDY
    I.G.O.N. 1 STUDY
    A.4.1Sponsor's protocol code numberGED-301-01-11
    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 SponsorGIULIANI
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGIULIANI S.P.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGIULIANI S.P.A.
    B.5.2Functional name of contact pointPHARMA DIVISION
    B.5.3 Address:
    B.5.3.1Street AddressVIA PALAGI 2
    B.5.3.2Town/ cityMILANO
    B.5.3.3Post code20129
    B.5.3.4CountryItaly
    B.5.4Telephone number+39020541
    B.5.6E-mailsbellinvia@giulianipharma.com
    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 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 nameGED-0301
    D.3.2Product code NA
    D.3.4Pharmaceutical form Modified-release 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 INNNA
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number160
    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 Yes
    D.3.11.13.1Other medicinal product typeOLIGONUCLEOTIDE ANTISENSO
    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
    ACTIVE CROHN'S DISEASE
    MORBO DI CROHN IN FASE ATTIVA
    E.1.1.1Medical condition in easily understood language
    ACTIVE CROHN'S DISEASE
    MORBO DI CROHN IN FASE ATTIVA
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10021315
    E.1.2Term Ileitis terminal
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    a. Efficacy: the primary efficacy endpoint will be the percentage of patients in remission defined as CDAI < 150 at day 15 (after 14 days of study drug treatment) wich is maintained at Week 4. b. Evaluation of safety of GED-0301, 14-day oral administration.
    a) Efficacia: l’obiettivo primario di efficacia dovra' essere la percentuale di pazienti in remissione definita come CDAI &lt; 150 al giorno 15 (dopo 14 giorni di trattamento con il prodotto in studio) che e' mantenuta alla Settimana 4. b) Valutazione della sicurezza di GED-0301, dopo 14 giorni di somministrazione orale.
    E.2.2Secondary objectives of the trial
    %of pts in remission at week 2,4 and at week 12 - %of patients attaining 70-point clinical response (defined as a decrease from baseline in CDAI score of 70 points or more) at week 4 and at week 12. -%of patients attaining 100-point clinical response (defined as a decrease from baseline in CDAI score of 100 points or more) at week 4 and at week 12. - Time to Symptoms Disappearance (SD) : for each symptom, time to disappearance is defined as the interval of time in days between the date of symptom disappearance, evaluated on the basis of the data recorded in the patient’s diary, and the date of randomisation . - %of steroid-dependent patients achieving steroid therapy discontinuation at week 12 - Change in the endoscopic index of severity for Crohn’s Disease (SES-CD).This analysis will be done in the patients who accept to perform ileocolonoscopy before treatment and at week 4
    - %di pz in remissione alla sett 2,4 e alla sett12 - %di pz che raggiungano 70-pt di risposta clinica,(definita come un decremento rispetto al basale nel punteggio CDAI di 70pt o piu') alla sett 4 e alla sett12 - %di pz che raggiungano 100-pt di risposta clinica,(decremento rispetto al basale nel punteggio CDAI di 100 pt o piu') alla sett4 e alla sett12. - Tempo di scomparsa dei sintomi(SD):per ciascun sintomo definito come l’intervallo di tempo in giorni fra la data della scomparsa del sintomo, valutata sulla base dei dati registrati nel diario del paziente,e la data di randomizzazione. - %di pz steroido dipendenti che raggiungono una discontinuita' nella terapia con steroidi alla sett12 - Variazione nell’indice SES-CD Quest`analisi verra' eseguita su pazienti che accettano di sottoporsi a ileocolonscopia prima del trattamento e alla settimana 4
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent, personally signed and dated by the patient prior any study-related procedures is carried out. 2. Male and female outpatients aging 18-75 years old. 3. Female patients not of childbearing potential (women in menopause defined as surgically sterile or one year postmenopausal); female patients of childbearing potential upon negative pregnancy testing at screening and using effective method of birth control during the study. 4. Patients with Crohn’s disease in the active phase at screening visit (the activity is defined using the Crohn’s disease Activity Index (CDAI) according to the European guidelines). 5. Crohn’s disease limited to terminal ileum and/or right colon,.that has been documented by instrumental information on localization and extension according to inclusion criteria 9. . 6. Patients with a CDAI score of >220 and ≤400 for at least one week prior to enrollment. 7. No treatment with biologics (e.g.:infliximab, adalimumab, or natalizumab), in the 90 days prior the enrolment. 8. Patients with steroid resistance or steroid dependence, defined according to the ECCO consensus document 9. Absence of Strictures with pre-stenotic dilatation documented by ultrasonography or Rx or NMR, performed within 1 year prior to the enrollment 10. Ability to understand and comply with study procedures and restrictions.
    1) Consenso informato scritto, firmato e datato personalmente dal paziente prima dell’esecuzione di qualsiasi procedura dello studio deve essere raccolto. 2) Pazienti di sesso maschile o femminile tra i 18 e i 75 anni di eta'. 3) Pazienti di sesso femminile potenzialmente non fertili (donne in menopausa definite come intervento chirurgico di sterilita' o in post-menopausa da un anno); pazienti di sesso femminile potenzialmente fertili con test di gravidanza negativo alla visita di screening e che facciano uso di un valido metodo contraccettivo durante lo studio. 4) Pazienti con diagnosi di morbo di Crohn in fase attiva alla visita di screening (l’attivita' e' definita utilizzando l’Indice di Attivita' del Morbo di Crohn (CDAI) in accordo alle linee guida Europee). 5) Malattia di Crohn limitata al segmento ileo terminale e/o al colon destro, che sia stata documentata da informazioni strumentali sulla localizzazione ed estensione in accordo al criterio di inclusione n. 9. 6) Pazienti con punteggio CDAI &gt;220 e ≤400 per almeno una settimana prima dell’arruolamento. 7) Nessun trattamento con biologici (es. infliximab, adalimumab o natalizumab) nei 90 giorni precedenti l’arruolamento. 8) Pazienti con resistenza agli steroidi o steroido dipendenza, definita in accordo all’ECCO consensus document. 9) Assenza di stenosi con dilatazione pre-stenotica documentata da ecografia o RX o RMN, eseguita entro 1 anno prima dell’arruolamento. 10) Capacita' di comprendere e di attenersi alle procedure e restrizioni dello studio.
    E.4Principal exclusion criteria
    Pregnant or breast-feeding women. 2. Patients with Ulcerative Colitis. 3. Patients with Crohn’s disease involving the stomach and/or the proximal small intestine, or patients with lesions confined to the transverse or left colon as assessed by standard clinical criteria. 4. Patients treated with biologics(e.g.:infliximab, adalimumab, or natalizumab), in the 90 days prior the enrolment. 5. Patients in treatment with a standard dose of immunomodulators (e.g.: azathioprine, mercaptopurine, methotrexate) maintained stably for less than 6 months (patients treated with a stable dose for at least 6 months are eligible).The standard doses, according to ECCO consensus document, are 2-2.5 mg/kg/day for azathioprine and 1-1.5 mg/kg/day for mercaptopurine. 6. Oral and/or systemic antibiotic treatment within 3 weeks before screening 7. Presence of local complications (e.g. abscesses, strictures and fistulae), dysplasia and malignancies. 8. A history of colon surgery performed within the past 12 months prior to first dose or an ileal resection more than 70 cm in the past. 9. Strictures with pre-stenotic dilatation. 10. Presence of stoma or ileo-recto-anastomosis. 11. Screening laboratory values within the following parameters:  APTT > 1.5 ULN  plateletcount ≤100,000 /mm3  serum creatinine >1.5 ULN  total bilirubin >1.5 ULN (excluding Gilbert Syndrome)  AST and ALT >1.5 ULN. 12. QTc interval >450 msec for males and >470 msec for females. 13. Current or relevant previous history of serious, severe or unstable (acute or progressive) physical or psychiatric illness, including infections, malignancy, medical disorder that may require treatment (e.g. renal or hepatic impairment) or that make the subject unlikely to fully complete the study, or any condition that presents undue risk from the study medication or procedures. 14. History of alcohol or other drug abuse within the last year. 15. Patients potentially presenting poor reliability (e.g. bad mental conditions). 16. Known hypersensitivity to oligonucleotides or any ingredient in the study products. 17. Patients who used another investigational agent or who took part in a clinical trial within the last 6 months prior first dose.
    1) Donne in gravidanza o in corso di allattamento. 2) Pazienti con Colite Ulcerosa 3) Pazienti con malattia di Crohn che coinvolge lo stomaco e/o la parte prossimale dell’intestino tenue o pazienti con lesioni confinate alla porzione trasversa o sinistra del colon come dimostrato dai criteri clinici standard. 4) Pazienti trattati con biologici (es.: infliximab, adalimumab o natalizumab), nei 90 giorni prima dell’arruolamento. 5) Pazienti in trattamento con una dose standard di immunomodulatori (es: azathioprine, mercaptopurine, methotrexate) mantenuta stabile da meno di 6 mesi (i pazienti trattati con una dose stabile da almeno 6 mesi sono eleggibili). Le dosi standard, in accordo all’ECCO Consensus document, sono 2-2.5 mg/kg/giorno per azathioprine e 1-1.5 mg/kg/giorno per mercaptopurine. 6) Pazienti trattati con antibiotici sistemici e/o orali nelle 3 settimane prima dello screening. 7) Presenza di complicazioni locali (es. ascessi, stenosi e fistole), displasia e tumori maligni. 8) Storia di interventi chirurgici intestinali, effettuati entro gli ultimi 12 mesi prima della prima dose o una resezione ileale superiore a 70 cm nel passato. 9) Stenosi con dilatazione pre-stenotica. 10) Presenza di stoma o ileo-retto-anastomosi. 11) Valori dei parametri di laboratorio allo screening con i seguenti valori:  APTT &gt; 1.5 ULN  Conta delle piastrine ≤100,000 /mm3  Creatinina serica &gt;1.5 ULN  Bilirubina totale &gt;1.5 ULN (esclusa la Sindrome di Gilbert)  AST e ALT &gt;1.5 ULN 12) Intervallo QTc &gt;450 msec per i maschi e &gt;470 msec per le femmine. 13) Concomitante o rilevante pregressa patologia, fisica o psichiatrica, grave o instabile (acuta o progressiva) incluse le infezioni, i tumori maligni, i disturbi che possono richiedere trattamento (come per esempio patologie renali o epatiche) o compromettere il completamento dello studio da parte del paziente o qualsiasi altra condizione considerata rischiosa in seguito all’assunzione del farmaco sperimentale o alle procedure dello studio. GED-301-01-11 Sinossi ITA vers. 3 del 15.11.2011 - Protocollo version 2.0 del 15.11.2011 (including Amendment 1) Pagina 5 di 9 14) Storia di alcolismo o abuso di alter sostanze nell’ultimo anno. 15) Pazienti potenzialmente poco affidabili (es. condizioni mentali precarie). 16) Nota ipersensibilita' agli oligonucleotidi o a qualsiasi altro componente del prodotto in studio. 17) Pazienti che hanno assunto un altro prodotto sperimentale o che hanno preso parte ad uno studio clinico nei 6 mesi precedenti alla prima dose.
    E.5 End points
    E.5.1Primary end point(s)
    a. Efficacy: the primary efficacy endpoint will be the percentage of patients in remission defined as CDAI < 150 at day 15 (after 14 days of study drug treatment) wich is maintained at Week 4. b. Evaluation of safety of GED-0301, 14-day oral administration.
    a) Efficacia: l’obiettivo primario di efficacia dovra' essere la percentuale di pazienti in remissione definita come CDAI < 150 al giorno 15 (dopo 14 giorni di trattamento con il prodotto in studio) che e' mantenuta alla Settimana 4. b) Valutazione della sicurezza di GED-0301, dopo 14 giorni di somministrazione orale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    14 days and 28 days
    14 giorni e 28 giorni
    E.5.2Secondary end point(s)
    %of pts in remission at week 2,4 and at week 12 - %of patients attaining 70-point clinical response (defined as a decrease from baseline in CDAI score of 70 points or more) at week 4 and at week 12. -%of patients attaining 100-point clinical response (defined as a decrease from baseline in CDAI score of 100 points or more) at week 4 and at week 12. - Time to Symptoms Disappearance (SD) : for each symptom, time to disappearance is defined as the interval of time in days between the date of symptom disappearance, evaluated on the basis of the data recorded in the patient’s diary, and the date of randomisation . - %of steroid-dependent patients achieving steroid therapy discontinuation at week 12 - Change in the endoscopic index of severity for Crohn’s Disease (SES-CD).This analysis will be done in the patients who accept to perform ileocolonoscopy before treatment and at week 4
    - %di pz in remissione alla sett 2,4 e alla sett12 - %di pz che raggiungano 70-pt di risposta clinica,(definita come un decremento rispetto al basale nel punteggio CDAI di 70pt o piu') alla sett 4 e alla sett12 - %di pz che raggiungano 100-pt di risposta clinica,(decremento rispetto al basale nel punteggio CDAI di 100 pt o piu') alla sett4 e alla sett12. - Tempo di scomparsa dei sintomi(SD):per ciascun sintomo definito come l’intervallo di tempo in giorni fra la data della scomparsa del sintomo, valutata sulla base dei dati registrati nel diario del paziente,e la data di randomizzazione. - %di pz steroido dipendenti che raggiungono una discontinuita' nella terapia con steroidi alla sett12 - Variazione nell’indice SES-CD Quest`analisi verra' eseguita su pazienti che accettano di sottoporsi a ileocolonscopia prima del trattamento e alla settimana 4
    E.5.2.1Timepoint(s) of evaluation of this end point
    14 days, week4 and week12
    14 giorni, settimana 4 e settimana 12
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 Yes
    E.8.2.3.1Comparator description
    - Stesso farmaco ad altro dosaggio
    - same IMP used at different dosage
    E.8.2.4Number of treatment arms in the trial4
    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 concerned13
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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: 140
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state160
    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)
    Investigator's decision
    Secondo il giudizio dello Sperimentatore Specialista
    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 Decision2011-07-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-09-30
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