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    Summary
    EudraCT Number:2018-000137-13
    Sponsor's Protocol Code Number:ORARIALS-01
    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:2021-01-22
    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 number2018-000137-13
    A.3Full title of the trial
    A Phase 3, Randomised, Placebo-Controlled Trial of Arimoclomol in Amyotrophic Lateral Sclerosis
    Studio di fase 3, randomizzato, controllato con placebo, su Arimoclomol per il trattamento della sclerosi laterale amiotrofica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to compare the use of Arimoclomol with placebo in patients with
    Amyotrophic Lateral Sclerosis
    Uno studio per comparare l'uso di Arimoclomol con placebo in pazienti affetti da sclerosi laterale amiotrofica
    A.3.2Name or abbreviated title of the trial where available
    na
    na
    A.4.1Sponsor's protocol code numberORARIALS-01
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03491462
    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 SponsorORPHAZYME APS
    B.1.3.4CountryDenmark
    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 supportOrphazyme A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOrphazyme A/S
    B.5.2Functional name of contact pointSenior Clinical Trial Manager
    B.5.3 Address:
    B.5.3.1Street AddressOle Maaløes Vej 3
    B.5.3.2Town/ cityCopenhagen N
    B.5.3.3Post codeDK-2200
    B.5.3.4CountryDenmark
    B.5.4Telephone number004531391062
    B.5.6E-mailhda@orphazyme.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/06/406
    D.3 Description of the IMP
    D.3.1Product nameArimoclomol
    D.3.2Product code [BRX-345]
    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 INNARIMOCLOMOL
    D.3.9.1CAS number 368860-21-3
    D.3.9.2Current sponsor codeBRX-345
    D.3.9.4EV Substance CodeSUB187159
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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.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, hard
    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
    Amyotrophic Lateral Sclerosis
    Sclerosi laterale amiotrofica
    E.1.1.1Medical condition in easily understood language
    Amyotrophic Lateral Sclerosis
    Sclerosi laterale amiotrofica
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10002026
    E.1.2Term Amyotrophic lateral sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the efficacy of chronic treatment with arimoclomol 1200 mg/day (400 mg TID) compared to placebo over 76 weeks in subjects with ALS as assessed with Combined Assessment of Function and Survival (CAFS)
    Determinazione dell’efficacia del trattamento cronico a base di arimoclomol a una dose di 1200 mg/giorno (400 mg TID) rispetto al placebo in un periodo di 76 settimane in soggetti affetti da SLA, valutata utilizzando il punteggio CAFS (Combined Assessment of Function and Survival, valutazione combinata di funzione e sopravvivenza)
    E.2.2Secondary objectives of the trial
    To evaluate the impact of arimoclomol 1200 mg/day (400 mg TID) compared to placebo on:
    • Time to permanent assisted ventilation (PAV)/tracheostomy free survival
    • Disease progression as measured by change from Baseline of the ALSFRS-R
    • Progression of respiratory dysfunction as measured by change from Baseline of the slow vital capacity (SVC)
    Valutazione dell’impatto di una dose di arimoclomol da 1200 mg/giorno (400 mg TID) rispetto al placebo su:
    • Tempo necessario per raggiungere l’obiettivo della sopravvivenza senza ventilazione assistita permanente (PAV)/tracheotomia
    • Progressione della malattia misurata valutando la variazione del punteggio ALSFRS-R dal baseline
    • Progressione della disfunzione respiratoria misurata valutando la variazione della capacità vitale lenta (SVC) dal baseline
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: Optional Muscle-strength and Electromyography testing.
    Muscle-strength and Electromyography will be measured in a sub-study conducted in approximately 40 subjects at selected trial sites.
    Electrophysiology and muscle-strength testing will be performed in the same subset of subjects at the following in-person visits; Baseline, Week 20, Week 52 and Week 76 (or end of trial).
    The assessments will only be performed if appropriate in the opinion of the investigator. Subjects will signed a separate consent form indicating their willingness to have this testing.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Test facoltativi di forza muscolare ed elettromiografia.
    La forza muscolare e l'elettromiografia saranno misurate in un sotto-studio condotto in circa 40 soggetti in centri selezionati.
    Le prove di elettrofisiologia e di forza muscolare saranno eseguite nello stesso sottogruppo di soggetti alle seguenti visite di persona; Basale, Settimana 20, Settimana 52 e Settimana 76 (o fine della sperimentazione).
    Le valutazioni verranno eseguite solo se appropriato, secondo il parere dello sperimentatore. I soggetti firmeranno un modulo di consenso separato che indica la loro volontà di sottoporsi a questo test.
    E.3Principal inclusion criteria
    1. Capable of- and willing to- provide written informed consent and comply with trial procedures.
    2. Subject is male or female =18 years of age.
    3. Subject meets revised El Escorial criteria for clinically possible, clinically probable / clinically probable ALS laboratory-supported or clinically definite ALS, or familial ALS.
    4. 18 months or less since first appearance of weakness (e.g. limb weakness, dysarthria, dysphagia, shortness of breath).
    5. ALSFRS-R =35 and erect SVC % predicted = 70% at Screening.
    6. Able and willing to travel to the site, and in the investigator's opinion is likely to attend visits for at least 24 weeks.
    7. All sexually active female subjects of child-bearing potential (postmenarchal)* must agree not to intend to become pregnant and use a highly effective method of contraception** during the trial through 1 month after the last dose of trial medication. If the subject is a sexually active male with female partners of child-bearing potential (postmenarchal) he must use a condom with or without spermicide in addition to the birth control used by their partners during the trial until 3 months after the last dose of trial medication.
    8. Stable dose of riluzole (50 mg twice daily) for a minimum of 14 days prior to Day 1 (Baseline), or has not taken it for 14 days prior to Day 1.
    1. Il soggetto è in grado di e disponibile a fornire il proprio consenso informato scritto e attenersi alle procedure previste dalla sperimentazione.
    2. Il soggetto è di sesso maschile o femminile e di età =18 anni.
    3. Il soggetto soddisfa i criteri di El Escorial per SLA clinicamente possibile, SLA clinicamente probabile, SLA clinicamente probabile con supporto di laboratorio, SLA clinicamente definita o SLA familiare clinicamente definita con supporto di laboratorio.
    4. Sono trascorsi meno di 18 mesi dalla prima comparsa di segni di debolezza (es. debolezza degli arti, disartria, disfagia, respiro corto).
    5. Il soggetto presenta punteggio ALSFRS-R =35 e SVC prevista in posizione eretta (seduto) = 70% al momento dello screening.
    6. Il soggetto è in grado di e disponibile a viaggiare per raggiungere il centro e, secondo il parere dello sperimentatore, e` probabile che si presenti alle visite per almeno 24 settimane.
    7. Tutte le donne sessualmente attive e in età fertile (fase post-menarcale)* devono acconsentire a non volere rimanere incinte e ad usare un metodocontraccettivo altamente efficace** durante la sperimentazione e fino a 1 mese dopo l’assunzione dell’ultima dose del farmaco sperimentale. Gli uomini sessualmente attivi con partner di sesso femminile in età fertile (fase post-menarcale) devono utilizzare un preservativo con o senza spermicida in aggiunta al metodo contraccettivo utilizzato dalla partner durante la sperimentazione e fino a 3 mesi dopo l’assunzione dell’ultima dose del farmaco sperimentale.
    8. Il soggetto ha ricevuto una dose stabile di riluzolo (50 mg due volte al giorno) per un minimo di 14 giorni prima del giorno 1 (baseline) oppure non ha assunto la dose nei 14 giorni antecedenti al giorno 1.
    E.4Principal exclusion criteria
    1. Tracheostomy or use of non-invasive ventilation for more than 2 hours during waking hours at the time of Screening and Baseline visits.
    2. Pregnant or breast-feeding.
    3. Current or anticipated use of diaphragmatic pacing during the trial.
    4. Exposure to any investigational treatment within 4 weeks or <5 halflives of the Screening visit, whichever is longest and/or advanced therapy medicinal product (ATMP), i.e. treatments based on genes, cells or tissues and/or participated in any prior ALS clinical trial receiving active drug treatment (with the exception described in exclusion criterion 5).
    5. Treatment with edaravone within 4 weeks of the Baseline visit. However, up to 18 subjects on stable (i.e. minimum 6 months') treatment with edaravone and who otherwise fulfil the eligibility criteria
    are planned for enrolment (limited to countries where edavarone has a marketing authorisation for treatment of ALS).
    6. Any of the following medically significant conditions:
    a) Neurological impairment/dysfunction or unstable psychiatric illness that in the investigator's opinion is likely to interfere with assessment of ALS disease progression.
    b) Clinically significant unstable medical condition other than ALS, which would present a risk to a subject to participate in the trial
    c) Presence of dementia that impairs the ability of the subject to provide informed consent according to the PI decision.
    d) Known or suspected allergy or intolerance to the IMP (arimoclomol or constituents);
    e) Chronic infection particularly HIV or Hepatitis B or C.
    f) Clinically significant renal or hepatic disease
    g) Aspartate aminotransferase and/or alanine aminotransferase, and/or lactate dehydrogenase =3 times the upper limit of normal [ULN], bilirubin=2 times the ULN, or creatinine =1.5 times the ULN). Laboratory tests may be repeated once at Screening. Reasons to repeat laboratory tests may include that the medication causing laboratory abnormality was suspended, any other suspected cause may no longer exist, or to rule out laboratory error.
    h) Cancer that is currently under active treatment or is likely to require treatment during the trial that may alter the subject´s function and thereby interfere with assessment of ALS disease progression.
    i) Any other condition that in the investigator's opinion would present a risk to a subject to participate in the trial, interfere with the assessment of safety or has an increased risk of causing death during the trial.
    1. Tracheotomia o ventilazione non invasiva per più di 2 ore durante le ore di veglia al momento delle visite di screening e baseline.
    2. Gravidanza o allattamento.
    3. Uso corrente o previsto di pacing diaframmatico durante la sperimentazione.
    4. Esposizione a qualsiasi trattamento sperimentale nelle 4 settimane o <5 emivite, a seconda di qual è il periodo più lungo, antecedenti la visita di screening e/o medicinali per terapie avanzate (ATMP), cioè trattamenti basati su geni, cellule o tessuti e/o partecipazione a qualsiasi sperimentazione precedente sulla SLA che prevedeva l’assunzione di un trattamento farmacologico attivo (l’unica eccezione è descritta nel criterio d'esclusione 5.
    5. Trattamento a base di edaravone entro le precedenti 4 settimane dalla visita basale. Tuttavia, è previsto l’arruolamento di un massimo di 18 soggetti riceventi un trattamento stabile (almeno 6 mesi) a base di edaravone e che soddisfano gli altri criteri di eleggibilità (questa possibilità vale solo per i paesi in cui edaravone dispone dell’autorizzazione all’immissione in commercio per il trattamento della SLA).
    6. Una qualsiasi delle seguenti condizioni clinicamente significative:
    a) Compromissione neurologica/disfunzione o patologia psichiatrica instabile che, secondo il parere dello sperimentatore, potrebbe interferire con la valutazione della progressione della SLA.
    b) Patologia instabile clinicamente significativa diversa dalla SLA, che potrebbe costituire un rischio per il soggetto che partecipa alla sperimentazione.
    c) Presenza di demenza che comprometta la capacità del soggetto di fornire il proprio consenso informato, secondo quanto deciso dallo sperimentatore principale.
    d) Allergia o intolleranza nota o sospetta all’IMP (ad arimoclomol o ai suoi componenti).
    e) Infezione cronica, specialmente da HIV oppure epatite B o C.
    f) Patologia epatica o renale clinicamente significativa.
    g) Aspartato aminotransferasi e/o alanina aminotransferasi e/o L-lattato deidrogenasi =3 volte il limite superiore del normale (ULN), bilirubina =2 volte l’ULN o creatinina =1,5 volte l’ULN. I test di laboratorio possono essere ripetuti una volta in occasione dello screening. È possibile ripetere i test di laboratorio se l’assunzione del farmaco che causava anomalie nei test è stata sospesa, se eventuali altre cause potrebbero non essere più rilevanti, oppure per escludere errori di laboratorio.
    h) Tumore attualmente trattato o che potrebbe richiedere un trattamento durante la sperimentazione, in grado di alterare le funzionalità del soggetto e quindi interferire con la valutazione della progressione della SLA.
    i) Qualsiasi altra condizione che, secondo il parere dello sperimentatore, potrebbe costituire un rischio per il soggetto che partecipa alla sperimentazione, interferire con la valutazione della sicurezza oppure aumentare il rischio di morte durante la sperimentazione.
    E.5 End points
    E.5.1Primary end point(s)
    Combined assessment of function and survival (CAFS) over a treatment period of 76 weeks (or end-of-trial)
    Valutazione combinata di funzione e sopravvivenza (CAFS) in un periodo di trattamento di 76 settimane (o al termine della sperimentazione)
    E.5.1.1Timepoint(s) of evaluation of this end point
    76 weeks (or end-of-trial)
    76 settimane (o al termine della sperimentazione)
    E.5.2Secondary end point(s)
    • Time to PAV/tracheostomy/death
    • Change from Baseline to Week 76 (or end-of-trial) in ALSFRS-R
    • Change from Baseline to Week 76 (or end-of-trial) in SVC
    • Tempo trascorso prima di PAV/tracheotomia/morte
    • Variazione del punteggio ALSFRS-R dal baseline alla settimana 76 (o al termine della sperimentazione)
    • Variazione della SVC dal baseline alla settimana 76 (o al termine della sperimentazione)
    E.5.2.1Timepoint(s) of evaluation of this end point
    76 weeks (or end-of-trial)
    76 settimane (o al termine della sperimentazione)
    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 Yes
    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 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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Canada
    France
    Germany
    Italy
    Netherlands
    Poland
    Spain
    Sweden
    Switzerland
    United Kingdom
    United States
    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
    LVLS
    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 months2
    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 months7
    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: 160
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 71
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 132
    F.4.2.2In the whole clinical trial 231
    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)
    Subjects who complete 76 weeks of randomised treatment will be offered participation in a separate open-label extension trial through means of a separate clinical trial protocol.
    Ai soggetti che completano le 76 settimane di trattamento randomizzato sarà proposto di partecipare a un altro studio di estensione in aperto con un protocollo a sé.
    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 Decision2018-09-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-08
    P. End of Trial
    P.End of Trial StatusCompleted
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