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    Summary
    EudraCT Number:2018-003221-29
    Sponsor's Protocol Code Number:XPF-008-201
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-01-22
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2018-003221-29
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of XEN1101 as Adjunctive Therapy in Focal-onset Epilepsy.
    Estudio aleatorizado, doble ciego, controlado con placebo, multicéntrico, para evaluar la seguridad, la tolerabilidad y la eficacia del XEN1101 como tratamiento adyuvante en la epilepsia de inicio focal
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multicenter study to evaluate the safety, tolerability and efficacy of XEN1101 as additional therapy to standard treatment in focal epilepsy.
    Estudio multicéntrico para evaluar la seguridad, tolerabilidad y eficacia de XEN1101 como terapia adicional al tratamiento estándar en la epilepsia focal
    A.4.1Sponsor's protocol code numberXPF-008-201
    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 SponsorXenon Pharmaceuticals Inc
    B.1.3.4CountryCanada
    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 supportXenon Pharmaceuticals Inc
    B.4.2CountryCanada
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPivotal S.L
    B.5.2Functional name of contact pointAlberto Viavattene
    B.5.3 Address:
    B.5.3.1Street AddressGobelas 19, La Florida
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28023
    B.5.3.4CountrySpain
    B.5.4Telephone number0034917081250
    B.5.5Fax number0034917081301
    B.5.6E-mailAlberto.Viavattene@pivotal.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 nameXEN1101
    D.3.2Product code XEN1101
    D.3.4Pharmaceutical form Capsule
    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 INNXEN1101
    D.3.9.2Current sponsor codeXEN1101
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation 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 nameXEN1101
    D.3.2Product code XEN1101
    D.3.4Pharmaceutical form Capsule
    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 INNXEN1101
    D.3.9.2Current sponsor codeXEN1101
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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.IMP: 3
    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 nameXEN1101
    D.3.2Product code XEN1101
    D.3.4Pharmaceutical form Capsule
    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 INNXEN1101
    D.3.9.2Current sponsor codeXEN1101
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 placeboCapsule
    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
    Adult focal (partial onset) epilepsy
    Epilepsia focal (de inicio parcial) del adulto
    E.1.1.1Medical condition in easily understood language
    Adult focal epilepsy
    Epilepsia focal del adulto
    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 10065337
    E.1.2Term Focal epilepsy
    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
    - To assess the efficacy of XEN1101 compared to placebo on focal seizure frequency in adults with focal epilepsy taking 1-3 antiepileptic drugs (AEDs)
    - To assess the safety and tolerability of XEN1101 in adults with focal epilepsy taking 1-3 AEDs
    - Evaluar la eficacia del XEN1101 frente a un placebo sobre la frecuencia de crisis focales en adultos con epilepsia focal que toman de 1 a 3 fármacos antiepilépticos (FAE)
    - Evaluar la seguridad y tolerabilidad del XEN1101 en adultos con epilepsia focal que toman de 1 a 3 FAE
    E.2.2Secondary objectives of the trial
    - To evaluate the 50% XEN1101 response rates in comparison to placebo
    - To evaluate trends in focal seizure frequency over time in the treatment period
    - To assess the effect of XEN1101 vs. placebo on seizure severity and impact in adults with focal epilepsy taking 1-3 AEDs
    - Evaluar las tasas de respuesta al 50% de XEN1101 en comparación con un placebo
    - Evaluar las tendencias en la frecuencia de crisis focales mientras transcurre el periodo de tratamiento
    - Evaluar el efecto del XEN1101 frente a un placebo en la intensidad de las crisis convulsivas y la repercusión en adultos con epilepsia focal que toman de 1 a 3 FAE
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Be properly informed of the nature and risks of the study and give informed consent in writing, prior to entering the study
    - BMI <35 kg/m2
    - Diagnosis (≥2 years) of focal epilepsy according to the International League Against Epilepsy [ILAE] Classification of Epilepsy (2017)
    - Treatment with a stable dose of 1 to 3 allowable current AEDs for at least one month prior to screening, during baseline, and throughout the duration of the study
    - Must be willing to comply with the contraception requirements
    - Able to keep accurate seizure diaries
    - Estar correctamente informados sobre la naturaleza y los riesgos del estudio, y otorgar un consentimiento informado por escrito, antes de ingresar en el estudio
    - IMC <35 kg/m2
    - Diagnóstico (≥2 años) de epilepsia focal de acuerdo con la clasificación de la epilepsia (2017) establecida por la Liga Internacional contra la Epilepsia (International League Against Epilepsy, ILAE)
    - Tratamiento con una dosis estable de 1 a 3 FAE actuales permitidos durante al menos un mes antes de la selección, durante la situación basal y durante todo el estudio
    - Estar dispuesto a cumplir con los requisitos anticonceptivos
    - Posibilidad de completar con exactitud los diarios de crisis convulsivas
    E.4Principal exclusion criteria
    - History of pseudoseizures, psychogenic seizures, primary generalized seizure, or focal aware non-motor seizures only
    - Presence or previous history of Lennox-Gastaut syndrome
    - Seizures secondary to other diseases or conditions
    - History of repetitive seizures within the last 12 months where the individual seizures cannot be counted
    - History of neurosurgery for seizures <1 year prior to enrollment, or radiosurgery <2 years prior to enrollment
    - Schizophrenia and other psychotic disorders, or active suicidal plan/intent in the past 6 months, or a history of suicide attempt in the last 2 years, or more than 1 lifetime suicide attempt
    - History or presence of any significant medical or surgical condition or uncontrolled medical illness at screening, or history of cancer within the past 2 years, with the exception of appropriately treated basal cell or squamous cell carcinoma
    - Any clinically significant abnormalities on pre-study physical examination, vital signs, laboratory values or ECG indicating a medical problem that would preclude study participation
    - Past use of vigabatrin without stable visual fields tested twice over the 12 months after the last dose of vigabatrin (concomitant use of vigabatrin is not allowed)
    - If felbamate is used as a concomitant AED, patients must be taking it for at least 2 years, with a stable dose for ≥49 days and acceptable hematology and LFT values (or discontinued felbamate no less than 49 days) prior to Screening
    - Have had multiple drug allergies or a severe drug reaction to an AED(s), including dermatological (e.g., Stevens-Johnson syndrome), hematological, or organ toxicity reactions
    - Current use of a ketogenic diet
    - Antecedentes de pseudocrisis, crisis psicógenas, crisis generalizadas primarias o únicamente de crisis focales conscientes no motoras
    - Presencia o antecedentes de síndrome de Lennox-Gastaut
    - Crisis secundarias a otras enfermedades o condiciones
    - Antecedentes de crisis repetitivas en el periodo de los 12 meses previos al ingreso en el estudio, donde no pueden contabilizarse las crisis individuales
    - Antecedentes de neurocirugía por crisis convulsivas > 1 año antes de la inclusión, o radiocirugía < 2 años antes de la inclusión
    - Esquizofrenia y otros trastornos psicóticos, planes/intenciones suicidas activas en los últimos 6 meses, o antecedentes de intento de suicidio en los últimos 2 años, o más de 1 intento de suicidio en la vida
    - Antecedentes o presencia de cualquier afección médica o quirúrgica significativa, o enfermedad médica no controlada en el momento de la selección, o antecedentes de cáncer en los últimos 2 años, a excepción del carcinoma de células basales o de células escamosas tratado adecuadamente
    - Cualquier anomalía clínicamente significativa en las exploraciones físicas, las constantes vitales, los resultados de laboratorio o los ECG previos al estudio que indique un problema médico que impediría la participación en el estudio
    - Uso de vigabatrina en el pasado sin campos visuales estables evaluados dos veces durante los 12 meses posteriores a la última dosis de vigabatrina (no está permitido el uso concomitante de vigabatrina)
    - Si se emplea felbamato como FAE concomitante, los pacientes deben haber estado en tratamiento con felbamato durante al menos 2 años, con una dosis estable durante ≥49 días y valores de hematología y pruebas de función hepática aceptables. Si los pacientes recibieron felbamato en el pasado, deben haber suspendido su uso no menos de 49 días antes de la selección
    - Haber tenido alergias a múltiples fármacos o una reacción medicamentosa intensa a un FAE, lo que incluye reacciones de toxicidad dermatológica (p. e, síndrome de Stevens-Johnson), hematológica u orgánica
    - Actualmente bajo dieta cetogénica
    E.5 End points
    E.5.1Primary end point(s)
    - Median percent change in monthly (28 days) focal seizure frequency from baseline compared to double-blind treatment period versus placebo
    - Severity and frequency of associated adverse events/serious adverse events (AEs/SAEs)
    - Clinically significant changes in clinical laboratory findings
    - Clinically significant changes in 12-lead ECG
    - Increase in suicide risk as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) including increase in suicidal thoughts or an attempt
    - Clinically significant changes in vital signs including blood pressure, pulse or weight
    - Clinically significant changes in urological symptoms including retention as measured by the American Urological Association (AUA) Symptom Index
    - Mediana del cambio porcentual en la frecuencia mensual (28 días) de crisis focales respecto de la situación basal en comparación con el periodo de tratamiento con doble ciego frente a placebo
    - Intensidad y frecuencia de los acontecimientos adversos/acontecimientos adversos graves (AA/AAG) asociados
    - Cambios clínicamente significativos en los hallazgos de laboratorio clínico
    - Cambios clínicamente significativos en los ECG de 12 derivaciones
    - Incremento del riesgo de suicidio evaluado según la escala de valoración del riesgo de suicidio de Columbia (C-SSRS), incluido el aumento de pensamientos suicidas o un intento de suicidio
    - Cambios clínicamente significativos en las constantes vitales, que incluyen la tensión arterial, el pulso o el peso
    - Cambios clínicamente significativos en los síntomas urológicos, incluida la retención, medida según el índice de síntomas establecido por la Asociación Urológica Estadounidense (AUA)
    E.5.1.1Timepoint(s) of evaluation of this end point
    When the 180th patient have completed the treatment period
    Cuando el paciente 180 complete el periodo de tratamiento
    E.5.2Secondary end point(s)
    - Responders are defined as patients experiencing ≥50% reduction in monthly (28 days) focal seizure frequency from baseline to treatment period
    - Median absolute, change and percent change from baseline in weekly focal seizure frequency for each week in the double-blind treatment period
    - Clinical and Patient Global Impression of Change scores during the double-blind treatment period
    - Los pacientes con respuesta terapéutica se definen como aquellos que presentan una reducción ≥50% en la frecuencia mensual (28 días) de crisis focales desde la situación basal hasta el periodo de tratamiento
    - La mediana del cambio absoluto y el cambio porcentual respecto de la situación basal en la frecuencia semanal de crisis focales para cada semana en el periodo de tratamiento con doble ciego
    - Puntuaciones de las escalas de impresión clínica global del cambio y de impresión global del cambio según el paciente durante el periodo de tratamiento doble ciego
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of the study
    Al final del estudio
    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 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 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 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    France
    Germany
    Spain
    United Kingdom
    United States
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    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: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 300
    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)
    None
    Ninguno
    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 Decision2019-04-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-18
    P. End of Trial
    P.End of Trial StatusOngoing
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