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    Summary
    EudraCT Number:2021-003425-30
    Sponsor's Protocol Code Number:EPX-100-001
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2022-03-23
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2021-003425-30
    A.3Full title of the trial
    A 20-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of EPX-100 (Clemizole HCl) as Adjunctive Therapy in Patients with Dravet Syndrome (ARGUS trial)
    Ensayo multicéntrico, aleatorizado, doble ciego y controlado con placebo, de 20 semanas de duración, de EPX-100 (clemizol HCl) como tratamiento complementario en pacientes con síndrome de Dravet (ensayo ARGUS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 20-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of EPX-100 (Clemizole HCl) as Adjunctive Therapy in Patients with Dravet Syndrome (ARGUS trial)
    Ensayo multicéntrico, aleatorizado, doble ciego y controlado con placebo, de 20 semanas de duración, de EPX-100 (clemizol HCl) como tratamiento complementario en pacientes con síndrome de Dravet (ensayo ARGUS)
    A.4.1Sponsor's protocol code numberEPX-100-001
    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 SponsorEpygenix Therapeutics, Inc.
    B.1.3.4CountryUnited States
    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 supportEpygenix Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLEON RESEARCH S.L.
    B.5.2Functional name of contact pointAlfonso García
    B.5.3 Address:
    B.5.3.1Street AddressC/Nicostrato Vela, s/n, M11.2 Parque Tecnológico León
    B.5.3.2Town/ cityLeon
    B.5.3.3Post code24009
    B.5.3.4CountrySpain
    B.5.4Telephone number+34987 261 064
    B.5.5Fax number+34987 216 243
    B.5.6E-mailagarcia@leonresearch.es
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation 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 nameEPX-100 (Clemizole Hydrochloride)
    D.3.2Product code EPX-100
    D.3.4Pharmaceutical form Oral solution
    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 INNCLEMIZOLE HYDROCHLORIDE
    D.3.9.1CAS number 1163-36-6
    D.3.9.2Current sponsor codeEPX-100
    D.3.9.4EV Substance CodeSUB01336MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number5 to 18
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral solution
    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
    Dravet Syndrome
    Síndrome de Dravet
    E.1.1.1Medical condition in easily understood language
    Dravet Syndrome
    Síndrome de Dravet
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of EPX-100 orally in divided doses as adjunctive
    therapy compared with placebo in participants with Dravet Syndrome, in
    terms of the mean percent change in countable convulsive seizure frequency
    (CCSF1) in the Titration and Maintenance (T+M) periods relative to baseline.
    Evaluar la eficacia de EPX-100 por vía oral, en dosis divididas, como tratamiento complementario, en comparación con un placebo, en participantes con síndrome de Dravet, en cuanto a la variación porcentual media de la frecuencia de crisis convulsivas contables (FCCC1) en los periodos de ajuste de la dosis y mantenimiento (A+M) con respecto al momento basal.
    E.2.2Secondary objectives of the trial
    To evaluate the difference between EPX100 vs placebo in proportion of participants with >25% reduction in the mean CCSF1 in the T+M periods relative
    to baseline.
    To evaluate the difference between EPX100 vs placebo in proportion of participants with >50% reduction in the mean CCSF1 in the T+M periods relative
    to baseline.
    To evaluate the mean difference between EPX-100 vs placebo per 28-days in the
    percent change of all seizures in the T+M periods relative to the baseline.
    To describe the difference between EPX100 vs placebo in the number
    of countable convulsive seizure-free days in the T+M periods relative to baseline.
    To describe the difference between EPX100 vs placebo per 28-days in the reduction in episodes of status epilepticus 2, in the T+M periods relative to the baseline.
    To describe the incidence of rescue antiepileptic drug (AED) use between treatment arms, as measured by the number of days on rescue AEDs in the T+M
    periods relative to the baseline.
    Evaluar la diferencia entre EPX-100 y el placebo en la proporción de participantes con una reducción >25 % de la media de FCCC1 en los periodos A+M con respecto al momento basal.
    Evaluar la diferencia entre EPX-100 y el placebo en la proporción de participantes con una reducción >50 % de la media de FCCC1 en los periodos A+M con respecto al momento basal.
    Evaluar la diferencia media entre EPX-100 y el placebo por 28 días en la variación porcentual de todas las crisis en los periodos A+M con respecto al momento basal.
    Describir la diferencia entre EPX-100 y el placebo en el número de días sin crisis convulsivas contables en los periodos A+M con respecto al momento basal.
    Describir la diferencia entre EPX-100 y el placebo por 28 días en la reducción de los episodios de estado epiléptico2 en los periodos A+M con respecto al momento basal.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Eligible participants must fulfill the following inclusion criteria:

    1. Male and female outpatient participants 2 years and older at time of consent.

    2. Clinical diagnosis of Dravet Syndrome. Participants must have seizures which are not completely controlled by AEDs with the following criteria:
    • Onset of seizures prior to 18 months of age,
    • Normal development at onset,
    • History of seizures that are generalized, unilateral clonic, and/or hemiclonic,
    • Brain MRI without cortical malformation, and
    • Genetic mutation of the SCN1A gene must be documented.

    3. The participant must be approved to participate by the PI after review of the medical history, baseline seizure diaries and inclusion/exclusion criteria. The Independent Reviewer will confirm Dravet Syndrome diagnosis for each participant enrolled in the study and adjudicate all seizure types on the seizure diaries.

    4. ≥4 countable convulsive seizures (hemiclonic, tonic-clonic, tonic, clonic, tonic/atonic (resulting in a drop), and focal with observable motor signs) per 4-week baseline period (Observational Phase).

    5. Participants should be on a stable regimen of AEDs ≥30 days prior to Visit 1 and generally in good health.

    6. Parent or LAR is able and willing to maintain an accurate and complete daily seizure calendar.

    7. Sexually active women of child-bearing potential (WCBP) must be using a medically acceptable method of birth control and have a negative urine pregnancy test at the screening visit. A WCBP is defined as a female who is biologically capable of becoming pregnant. A medically acceptable method of birth control includes intrauterine devices in place for at least
    3 months, surgical sterilization, or adequate barrier methods (e.g., diaphragm and foam). Use of oral contraceptives in combination with another method (e.g., a spermicidal cream) is acceptable. In participants who are not sexually active, abstinence is an acceptable form of birth control and urine will be tested per protocol. Women who are of non-child-bearing potential, i.e., post-menopause, must have this condition captured in their medical history. Pregnant women are excluded from this study.

    8. Have parent or LAR available and willing to give written informed consent, after being properly informed of the nature and risks of the study and prior to engaging in any study- related procedures.
    Los participantes elegibles deben cumplir los siguientes criterios de inclusión:

    1. Participantes masculinos y femeninos en régimen ambulatorio de 2 años o más en el momento del consentimiento.

    2. Diagnóstico clínico de síndrome de Dravet. Los participantes deben tener convulsiones que no estén completamente controladas por los FAE con los siguientes criterios:
    - Inicio de las convulsiones antes de los 18 meses de edad,
    - Desarrollo normal al inicio,
    - Historia de convulsiones generalizadas, clónicas unilaterales y/o hemiclónicas,
    - IRM del cerebro sin malformación cortical, y
    - Debe documentarse la mutación genética del gen SCN1A.

    3. El participante debe ser aprobado para participar por el IP después de la revisión del historial médico, los diarios de convulsiones de referencia y los criterios de inclusión/exclusión. El revisor independiente confirmará el diagnóstico del síndrome de Dravet para cada participante inscrito en el estudio y adjudicará todos los tipos de convulsiones en los diarios de convulsiones.

    4. ≥4 crisis convulsivas contables (hemiclónicas, tónico-clónicas, tónicas, clónicas, tónicas/atónicas (con resultado de caída) y focales con signos motores observables) por período de referencia de 4 semanas (Fase de Observación).

    5. Los participantes deben estar en un régimen estable de FAE ≥30 días antes de la Visita 1 y, en general, gozar de buena salud.

    6. Los padres o el LAR son capaces y están dispuestos a mantener un calendario diario de convulsiones preciso y completo.

    7. Las mujeres sexualmente activas con potencial de tener hijos (WCBP) deben utilizar un método anticonceptivo médicamente aceptable y tener una prueba de embarazo en orina negativa en la visita de selección. Una WCBP se define como una mujer que es biológicamente capaz de quedarse embarazada. Un método anticonceptivo médicamente aceptable incluye dispositivos intrauterinos colocados durante al menos
    3 meses, esterilización quirúrgica o métodos de barrera adecuados (por ejemplo, diafragma y espuma). El uso de anticonceptivos orales en combinación con otro método (por ejemplo, una crema espermicida) es aceptable. En los participantes que no son sexualmente activos, la abstinencia es una forma aceptable de control de la natalidad y la orina se analizará según el protocolo. Las mujeres que no tienen potencial para tener hijos, es decir, que son posmenopáusicas, deben tener esta condición registrada en su historial médico. Las mujeres embarazadas están excluidas de este estudio.

    8. Tener padres o un representante legal disponible y dispuesto a dar su consentimiento informado por escrito, después de haber sido debidamente informado de la naturaleza y los riesgos del estudio y antes de participar en cualquier procedimiento relacionado con el estudio.
    E.4Principal exclusion criteria
    The presence of any of the following excludes a participant from study enrollment:

    1. Known sensitivity, allergy, or previous exposure to EPX-100 (clemizole HCl).
    2. Exposure to any investigational drug or device <90 days prior to screening or plans to participate in another drug or device trial at any time during the study.

    3. Seizures secondary to illicit drug or alcohol use, infection, neoplasm, demyelinating disease, degenerative neurological disease, or central nervous system (CNS) disease deemed progressive, metabolic illness, or progressive degenerative disease.

    4. Concurrent use of drugs known to interfere with EPX-100, including moderate or severe inducers or inhibitors of CYP3A4/5/7. Specifically, concurrent use of carbamazepine, oxcarbazepine, phenytoin, and/or phenobarbital, as well as refraining from grapefruits and grapefruit juice during the study period. Refer to Appendix 1 for a list of prohibited drugs.

    5. Prior or concurrent use of fenfluramine or lorcaserin.

    6. Has any medical condition that, in the PI's judgment, is considered to be clinically significant and could potentially affect participant safety or study outcome, including but not limited to: clinically significant cardiac disease (including angina, congestive heart failure, uncontrolled hypertension, and history of arrhythmias), renal, pulmonary, gastrointestinal, hematologic or hepatic conditions; or a condition that affects the absorption, distribution, metabolism, or excretion of drugs.

    7. Has an active suicidal plan/intent or have had active suicidal thoughts in the past 6 months or a suicide attempt in the past 3 years.
    La presencia de cualquiera de los siguientes factores excluye a un participante de la inscripción en el estudio:

    1. Sensibilidad conocida, alergia o exposición previa a EPX-100 (clemizol HCl).
    2. Exposición a cualquier fármaco o dispositivo en investigación <90 días antes de la selección o planes para participar en otro ensayo de fármacos o dispositivos en cualquier momento del estudio.

    3. Convulsiones secundarias al consumo de drogas ilícitas o alcohol, infección, neoplasia, enfermedad desmielinizante, enfermedad neurológica degenerativa o enfermedad del sistema nervioso central (SNC) considerada progresiva, enfermedad metabólica o enfermedad degenerativa progresiva.

    4. Uso simultáneo de medicamentos que se sabe que interfieren con el EPX-100, incluidos los inductores o inhibidores moderados o graves del CYP3A4/5/7. En concreto, el uso simultáneo de carbamazepina, oxcarbazepina, fenitoína y/o fenobarbital, así como la abstención de tomar pomelos y zumo de pomelo durante el periodo del estudio. Consulte el Apéndice 1 para ver la lista de medicamentos prohibidos.

    5. Uso previo o concurrente de fenfluramina o lorcaserina.

    6. Tiene cualquier condición médica que, a juicio del IP, se considere clínicamente significativa y pueda afectar potencialmente a la seguridad del participante o al resultado del estudio, incluyendo pero sin limitarse a: enfermedad cardíaca clínicamente significativa (incluyendo angina, insuficiencia cardíaca congestiva, hipertensión no controlada y antecedentes de arritmias), condiciones renales, pulmonares, gastrointestinales, hematológicas o hepáticas; o una condición que afecte a la absorción, distribución, metabolismo o excreción de los fármacos.

    7. Tiene un plan/intento de suicidio activo o ha tenido pensamientos suicidas activos en los últimos 6 meses o un intento de suicidio en los últimos 3 años.
    E.5 End points
    E.5.1Primary end point(s)
    The mean percent change between EPX-100 vs placebo in CCSF1 in the T+M
    periods relative to baseline.
    Variación porcentual media de la FCCC1 entre EPX-100 y el placebo en los periodos A+M con respecto al momento basal.
    E.5.1.1Timepoint(s) of evaluation of this end point
    20 weeks
    20 semanas
    E.5.2Secondary end point(s)
    The difference between EPX-100 vs placebo in proportion of participants with
    >25% reduction in the mean CCSF1 in the T+M periods relative to baseline.
    The difference between EPX-100 vs placebo in proportion of participants with >50% reduction in the mean CCSF1 in the T+M periods relative to baseline.
    The mean difference between EPX-100 vs placebo per 28-days in the percent change all seizures in the T+M periods relative to the baseline.
    The difference between EPX-100 vs placebo in the number of countable convulsive seizure-free days in the T+M periods relative to baseline.
    The difference between EPX-100 vs placebo per 28-days in the change in number of episodes of status epilepticus2 in the T+M periods relative to the
    baseline.
    The difference between EPX-100 vs placebo in the incidence of rescue antiepileptic drug (AED) use as measured by the number of days on rescue AEDs in the T+M periods relative to the baseline.
    Diferencia entre EPX-100 y el placebo en la proporción de participantes con una reducción >25 % de la media de FCCC1 en los periodos A+M con respecto al momento basal.
    Diferencia entre EPX-100 y el placebo en la proporción de participantes con una reducción >50 % de la media de FCCC1 en los periodos A+M con respecto al momento basal.
    Diferencia media entre EPX-100 y el placebo por 28 días en la variación porcentual de todas las crisis en los periodos A+M con respecto al momento basal.
    Diferencia entre EPX-100 y el placebo en el número de días sin crisis convulsivas contables en los periodos A+M con respecto al momento basal.
    Diferencia entre EPX-100 y el placebo por 28 días en la variación del número de episodios de estado epiléptico2 en los periodos A+M con respecto al momento basal.
    Diferencia entre EPX-100 y el placebo en la incidencia del uso de antiepilépticos (AE) de rescate, determinada por el número de días con AE de rescate en los periodos A+M con respecto al momento basal.
    E.5.2.1Timepoint(s) of evaluation of this end point
    20 weeks
    20 semanas
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic 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) 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 No
    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 concerned4
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    United States
    United Kingdom
    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
    LPLV
    ultima visita del ultimo paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months5
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 74
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 74
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 74
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 74
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 74
    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 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 74
    F.4.2.2In the whole clinical trial 74
    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)
    na
    na
    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 Decision2022-07-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-04-28
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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