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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7312   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2021-002686-18
    Sponsor's Protocol Code Number:EP0162
    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:2021-09-30
    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 number2021-002686-18
    A.3Full title of the trial
    A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Outpatient, Parallel-Group Study to Assess the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures
    Studio in doppio cieco, randomizzato, controllato con placebo, multicentrico, in regime ambulatoriale, a gruppi paralleli per valutare l’efficacia e la sicurezza di Staccato alprazolam in partecipanti allo studio di età pari o superiore a 12 anni con crisi convulsive stereotipate prolungate
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test the efficacy and safety of Staccato alprazolam in study participants 12 years of age and older with epilepsy
    Uno studio per verificare l'efficacia e la sicurezza di Staccato alprazolam nei partecipanti allo studio di età maggiore o uguale a 12 anni con epilessia
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code numberEP0162
    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 SponsorUCB Biopharma SRL
    B.1.3.4CountryBelgium
    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 supportUCB Biopharma SRL
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCB BIOSCIENCES GmbH
    B.5.2Functional name of contact pointClin Trial Reg & Results Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressAlfred-Nobel-Strasse 10
    B.5.3.2Town/ cityMonheim
    B.5.3.3Post code40789
    B.5.3.4CountryGermany
    B.5.6E-mailclinicaltrials@ucb.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 nameStaccato alprazolam
    D.3.2Product code [UCB7538]
    D.3.4Pharmaceutical form Inhalation powder
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNALPRAZOLAM
    D.3.9.2Current sponsor code-
    D.3.9.3Other descriptive nameALPRAZOLAM
    D.3.9.4EV Substance CodeSUB05370MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 Yes
    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 placeboInhalation powder
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment of stereotypical seizure
    Trattamento di crisi convulsive stereotipate
    E.1.1.1Medical condition in easily understood language
    Epilepsy
    Epilessia
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10076333
    E.1.2Term Prolonged seizure
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Comparison of the success of a single administration of Staccato alprazolam compared with placebo both in rapidly terminating a seizure episode within 90 seconds and with no recurrence of seizure(s) up to 2 hours after IMP administration.
    Confronto del successo di una singola somministrazione di Staccato alprazolam rispetto al placebo sia nel far cessare rapidamente un episodio di convulsioni entro 90 secondi sia senza ricorrenza di convulsione(i) fino a 2 ore dopo la somministrazione dell'IMP
    E.2.2Secondary objectives of the trial
    - Comparison of the success of a single administration of Staccato alprazolam compared with placebo both in rapidly terminating a seizure episode within 90 seconds and with no recurrence of seizure(s) up to 4 hours after IMP administration
    - Comparison of the success of a single administration of Staccato alprazolam compared with placebo both in rapidly terminating a seizure episode within 90 seconds and with no recurrence of seizure(s) up to 6 hours after IMP administration
    - Comparison of the time from IMP administration to cessation of the treated seizure between Staccato alprazolam and placebo
    - Evaluate the pulmonary safety of a single dose of Staccato alprazolam compared with placebo
    - Comparison of the occurrence of subsequent seizure(s) up to 2 hours after IMP administration between Staccato alprazolam and placebo
    - Confronto del successo di una singola somministrazione di Staccato alprazolam rispetto al placebo sia nel far cessare rapidamente un episodio di crisi entro 90 secondi sia senza ricorrenza di crisi fino a 4 ore dopo la somministrazione di IMP
    - Confronto del successo di una singola somministrazione di Staccato alprazolam rispetto al placebo sia nel far cessare rapidamente un episodio di crisi entro 90 secondi sia senza ricorrenza di crisi fino a 6 ore dopo la somministrazione di IMP
    - Confronto del tempo dalla somministrazione di IMP alla cessazione della crisi epilettica trattata tra Staccato alprazolam e placebo
    - Valutare la sicurezza polmonare di una singola dose di Staccato alprazolam rispetto al placebo
    - Confronto del verificarsi di successive crisi epilettiche fino a 2 ore dopo la somministrazione di IMP tra Staccato alprazolam e placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Participant must be >= 12 years of age at the Baseline/Randomization Visit
    - Participant must have a caregiver >=18 years of age at the Screening Visit; the caregiver(s) must be able to recognize and observe the participant's seizures
    - Participants with an established diagnosis of focal or generalized epilepsy or combined focal and generalized epilepsy with a documented history of stereotypical episodes of prolonged seizures that includes at least 1 of the following:
    a) Generalized seizure episodes starting with a flurry of absence seizures or myoclonic seizures with a minimum total duration of 5 minutes
    b) Episodes of a focal seizure with a minimum duration of 3 minutes
    c) Episodes of a focal seizure or myoclonic seizure for at least 90 seconds followed by a generalized/bilateral tonic-clonic seizure with a minimum total duration of 3 minutes
    - Prior to the Screening Visit, participant has experienced >=4 stereotypical episodes of prolonged seizures in the past 6 months, and the last 2 stereotypical episodes of prolonged seizures must have occurred within the 3 months prior to the Screening Visit
    - Male and female participants:
    a) A male participant must agree to use contraception during the Treatment Period and for at least 7 days after investigational medicinal product (IMP) administration
    b) A female participant is eligible to participate if she is not pregnant, not breastfeeding, and:
    i) Not a woman of childbearing potential (WOCBP) OR
    ii) A WOCBP who agrees to follow the contraceptive during the Treatment Period and for at least 30 days after IMP administration
    - Participant is capable of giving signed informed consent (or giving assent, where required). The informed consent form (ICF), or a specific assent form, where required, will be signed and dated by minors
    - The participant's caregiver(s) must be capable of giving signed informed consent), which includes compliance with the requirements and restrictions listed in the ICF, the protocol, and the individualized participant management plan (iPMP)
    - Il partecipante deve avere un’età >= 12 anni alla visita basale/di randomizzazione.
    - Il partecipante deve disporre di un assistente di età >= 18 anni al momento della visita di screening; l’assistente deve essere in grado di riconoscere e osservare le crisi convulsive del partecipante.
    - Partecipanti con diagnosi accertata di epilessia focale o generalizzata o epilessia focale e generalizzata combinata con anamnesi documentata di episodi stereotipati di crisi convulsive prolungate che includono almeno 1 dei seguenti elementi:
    a) Episodi di crisi convulsive generalizzate che iniziano con un attacco di crisi convulsiva di assenza o crisi convulsiva mioclonica con una durata totale minima di 5 minuti
    b) Episodi di crisi convulsiva focale con una durata minima di 3 minuti
    c) Episodi di crisi convulsive focali o miocloniche per almeno 90 secondi, seguite da una crisi convulsiva tonico-clonica generalizzata/bilaterale con una durata totale minima di 3 minuti
    - Prima della visita di screening, il partecipante ha manifestato >= 4 episodi stereotipati di crisi convulsive prolungate negli ultimi 6 mesi e gli ultimi 2 episodi stereotipati di crisi convulsive prolungate devono essersi manifestati nei 3 mesi precedenti la visita di screening.
    Partecipanti di sesso maschile e femminile:
    - Un partecipante deve acconsentire all’utilizzo della contraccezione seguendo le linee guida in materia durante il periodo di trattamento in regime ambulatoriale e per almeno 7 giorni dopo la somministrazione dell’IMP
    - Una partecipante è idonea a partecipare se non è in gravidanza, se non sta allattando al seno e:
    i) Non è una donna in età fertile (WOCBP) OPPURE
    ii) È una WOCBP che acconsente a seguire le linee guida in materia di contraccezione durante il periodo di trattamento e per almeno 30 giorni dopo la somministrazione dell’IMP.
    - Il partecipante è in grado di fornire il consenso informato firmato (o dare il consenso, ove richiesto). Il modulo di consenso informato (ICF), o uno specifico modulo di assenso, ove richiesto, sarà firmato e datato dai minori
    - I caregiver del partecipante devono essere in grado di fornire il consenso informato firmato), che include la conformità ai requisiti e alle restrizioni elencati nell'ICF, nel protocollo e nel piano di gestione individualizzato del partecipante (iPMP)
    E.4Principal exclusion criteria
    - Participant has a history of convulsive status epilepticus in the 8 weeks prior to the Screening Visit
    - Participant has a history or presence of known nonepileptic seizures which cannot be distinguished from qualifying epileptic seizures
    - Participant has a clinically significant known airway hypersensitivity (eg, bronchospasm to known allergens, such as pollen, animals, or food) and/or acute respiratory signs/symptoms (eg, shortness of breath, wheezing on lung auscultation)
    - Participant has a clinically significant chronic pulmonary disorder (eg,asthma, chronic obstructive pulmonary disease, restrictive lung diseases [including idiopathic pulmonary fibrosis]) and/or recent history or presence of hemoptysis or pneumothorax
    - Participant has a condition for which oral alprazolam is contraindicated (eg, myasthenia gravis, severe respiratory insufficiency, and sleep apnea syndrome)
    - Chronic use of benzodiazepines for more than 3 days within a period of 7 days will be allowed for approximately 30 % of study participants
    - Participant is taking any drug that is a strong CYP3A4 inhibitor, including azole antifungal agents (ketoconazole and itraconazole) and nefazodone
    - Participant is taking any opioids (eg, fentanyl, oxycodone, morphine) or sedative hypnotics on a chronic basis
    - Participant is taking nonselective beta blockers (eg, propranolol, nadolol, and timolol) on a chronic basis
    - Participant has an forced expiratory volume in 1 second (FEV1) <80 % of predicted FEV1 as measured via spirometry at the Screening Visit
    - Participant has an oxygen saturation <95 % for greater than 30 seconds during the Screening Visit
    - Participant cannot actuate the Staccato training device at the Screening Visit and the Baseline/Randomization Visit
    - Il partecipante presenta un’anamnesi di stato epilettico convulsivo nelle 8 settimane precedenti alla visita di screening
    - Il partecipante presenta un’anamnesi o presenza di crisi convulsive non epilettiche note, che non possono essere distinte dalle crisi convulsive epilettiche qualificanti
    - Il partecipante presenta un’ipersensibilità delle vie aeree nota clinicamente significativa (ad es., broncospasmo ad allergeni noti, come polline, animali o cibo) e/o segni/sintomi respiratori acuti (ad es., respiro affannoso, sibilo all’auscultazione polmonare)
    - Il partecipante presenta un disturbo polmonare cronico clinicamente significativo (ad es., asma, broncopneumopatia cronica ostruttiva, malattie polmonari restrittive [inclusa la fibrosi polmonare idiopatica]) e/o anamnesi recente o presenza di emottisi o pneumotorace
    - Il partecipante presenta una condizione per la quale alprazolam orale è controindicato (ad es., miastenia gravis, grave insufficienza respiratoria e sindrome da apnea notturna)
    - L’uso cronico di benzodiazepine per più di 3 giorni entro un periodo di 7 giorni sarà consentito per circa il 30% dei partecipanti allo studio
    - Il partecipante sta assumendo qualsiasi farmaco che è un forte inibitore del citocromo P450 (CYP) 3A4, compresi gli agenti antimicotici azolici (ketoconazolo e itraconazolo) e nefazodone
    - Il partecipante sta assumendo oppioidi (ad es., fentanil, ossicodone, morfina) o ipnotici sedativi su base cronica
    - Il partecipante sta assumendo beta-bloccanti non selettivi (ad es., propranololo, nadololo e timololo) su base cronica
    - Il partecipante presenta un volume espiratorio forzato in 1 secondo (FEV1) <80% del FEV1 previsto, misurato mediante spirometria alla visita di screening
    - Il partecipante presenta una saturazione di ossigeno <95% per più di 30 secondi durante la visita di screening
    - Il partecipante non può attivare il dispositivo Staccato durante la visita di screening e la visita di riferimento/randomizzazione
    E.5 End points
    E.5.1Primary end point(s)
    Treatment success for the treated seizure with no recurrence after 2 hours
    Successo del trattamento per la crisi convulsiva trattata senza recidiva dopo 2 ore
    E.5.1.1Timepoint(s) of evaluation of this end point
    From start of IMP treatment through 2 hours
    Dall'inizio del trattamento IMP fino a 2 ore
    E.5.2Secondary end point(s)
    1. Treatment success for treated seizure with no recurrence after 4 hours
    2. Treatment success for treated seizure with no recurrence after 6 hours
    3. Time from IMP administration to cessation of the treated seizure
    4. Frequency of respiratory treatment emergent adverse events (TEAEs)
    5. Number of subsequent seizure(s) up to 2 hours after IMP administration
    6. Time to first subsequent seizure up to 2 hours after IMP administration
    1. Successo del trattamento per crisi epilettiche trattate senza recidiva dopo 4 ore
    2. Successo del trattamento per crisi epilettiche trattate senza recidiva dopo 6 ore
    3. Tempo dalla somministrazione dell'IMP alla cessazione della crisi epilettica trattata
    4. Frequenza degli eventi avversi emergenti dal trattamento respiratorio (TEAE)
    5. Numero di successivi convulsioni fino a 2 ore dopo la somministrazione di IMP
    6. Tempo alla prima convulsione successiva fino a 2 ore dopo la somministrazione di IMP
    E.5.2.1Timepoint(s) of evaluation of this end point
    1: From start of IMP treatment through 4 hours
    2&3: From start of IMP treatment through 6 hours
    4: From start of IMP treatment up to the Safety Follow-up Visit (Week 19)
    5&6: From start of IMP treatment through 2 hours; 1: Dall'inizio del trattamento IMP fino a 4 ore
    2&3: Dall'inizio del trattamento IMP fino a 6 ore
    4: Dall'inizio del trattamento con IMP fino alla visita di controllo di sicurezza (Settimana 19)
    5 e 6: Dall'inizio del trattamento con IMP fino a 2 ore
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tollerabilità
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA43
    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
    Australia
    Japan
    Ukraine
    United States
    Bulgaria
    France
    Germany
    Hungary
    Italy
    Poland
    Spain
    United Kingdom
    Czechia
    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 years0
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days25
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days21
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 35
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 78
    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)
    After completing the study, eligible study participants will be allowed to enroll in an open-label extension (OLE) study (EP0165).
    Dopo aver completato lo studio, i partecipanti idonei allo studio potranno iscriversi a uno studio di estensione in aperto (OLE) (EP0165).
    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 Decision2021-12-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-17
    P. End of Trial
    P.End of Trial StatusOngoing
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