Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.

    The EU Clinical Trials Register currently displays   41491   clinical trials with a EudraCT protocol, of which   6826   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).

    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools

    < Back to search results

    Print Download

    EudraCT Number:2013-005164-26
    Sponsor's Protocol Code Number:DS5565-A-E312
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-11-25
    Trial results View results
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2013-005164-26
    A.3Full title of the trial
    An Open-Label Extension Study of DS-5565 for 52 Weeks in Pain Associated with Fibromyalgia
    Estudio de extensión abierto de DS-5565 de 52 semanas de duración para el tratamiento del dolor asociado a la fibromialgia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 52 week clinical trial with the test compound DS-5565, in patients who suffer from pain related to fibromyalgia
    Ensayo clínico de 52 semanas con el compuest en investigación DS-5565 en pacientes que padecen dolor asociado a la fibromialgia.
    A.4.1Sponsor's protocol code numberDS5565-A-E312
    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 SponsorDaiichi Sankyo Development Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportDaiichi Sankyo Development Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDaiichi Sankyo Development Ltd
    B.5.2Functional name of contact pointClinical Trial Application
    B.5.3 Address:
    B.5.3.1Street AddressChiltern Place, Chalfont Park
    B.5.3.2Town/ cityGerrards Cross, Buckinghamshire
    B.5.3.3Post codeSL9 0BG
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+34917088600
    B.5.5Fax number+441753899107
    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 nameDS-5565
    D.3.2Product code DS-5565
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNMirogabalin
    D.3.9.2Current sponsor codeDS-5565
    D.3.9.3Other descriptive nameDS-5565
    D.3.9.4EV Substance CodeSUB60040
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    DS-5565 is being developed for the treatment of pain associated with fibromyalgia (FM).
    DS-5565 está siendo desarrollado para el tratamiento del dolor asociado a la fibromialgia (FM).
    E.1.1.1Medical condition in easily understood language
    Treatment of pain related to fibromyalgia
    Tratamiento del dolor asociado a la fibromialgia
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10048439
    E.1.2Term Fibromyalgia
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    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 long-term safety of DS-5565 in subjects with FM
    Evaluar la seguridad a largo plazo de DS-5565 en sujetos con FM
    E.2.2Secondary objectives of the trial
    ? To observe the effects of DS-5565 on average daily pain score (ADPS) and pain-associated average daily sleep interference score (ADSIS) (both recorded in a diary). Weekly ADPS is based on daily pain scores reported by the subject that best describes his or her worst pain over the previous 24 hours.
    ? To observe the effects of DS-5565 on Patient Global Impression of Change (PGIC)
    ? To observe the effects of DS-5565 on depression and anxiety as assessed by the Hospital Anxiety and Depression Scale (HADS)
    ? To observe the effects of DS-5565 on subject quality of life as assessed by the EuroQoL Instrument 5 Domains (EQ-5D) and the Short Form 36 (SF-36).
    ? Observar los efectos de DS-5565 en la puntuación media diaria del dolor (average daily pain score, ADPS) y la interferencia con el sueño asociada al dolor según la puntuación media de interferencia con el sueño diario (average daily sleep interference score, ADSIS) (ambas registradas en un diario). La ADPS semanal se basa en las puntuaciones de dolor diarias declaradas por el sujeto, que mejor describen su pico de dolor más elevado durante las últimas 24 horas.
    ? Observar los efectos de DS-5565 en la impresión global del paciente sobre los cambios (Patient Global Impression of Change, PGIC).
    ? Observar los efectos de DS-5565 sobre la depresión y la ansiedad evaluadas según la escala hospitalaria de ansiedad y depresión (Hospital Anxiety and Depression Scale, HADS).
    ? Observar los efectos de DS-5565 sobre la calidad de vida del sujeto evaluada según el cuestionario EuroQoL de 5 dominios (EuroQoL 5 Domains, EQ-5D) y el formulario 36 abreviado (Short Form 36, SF-36).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects who completed one of the preceding Phase 3 DS-5565 study (DS5565-A-E309, DS5565-A-E310, or DS5565-A-E311):
    1. Able to give written informed consent
    2. Completed participation (i.e. completed the End-of-Tapering visit) in a preceding study of DS-5565 in FM (DS5565-A-E309, DS5565-A-E310, or DS5565-A-E311)
    3. Women of child-bearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy during the study and for 4 weeks after study completion
    4. The subject must not have experienced any significant safety issues
    during the preceding study that, in the investigator?s judgment, would
    adversely impact the subject?s well-being in the long-term extension
    Sujetos que completaron un estudio en fase III de DS-5565 (DS5565-A-E309, DS5565-A-E310 o DS5565-A-E311)
    1. Capacidad para dar el consentimiento informado por escrito.
    2. Finalizaron la participación (es decir, completaron la visita de fin de reducción gradual de la dosis) en un estudio previo de DS-5565 en la FM (DS5565-A-E309, DS5565-A-E310 o DS5565-A-E311).
    3. Las mujeres en edad fértil (women of child-bearing potential, WOCBP) deben estar utilizando un método anticonceptivo adecuado (según se detalla en el cuerpo del protocolo) con el fin de evitar quedarse embarazadas durante el estudio y durante 4 semanas después de completar el estudio.
    4. El sujeto no debe haber tenido ningún problema de seguridad significativo durante el estudio previo que, a juicio del investigador, afectara negativamente al bienestar del sujeto en la extensión a largo plazo.
    E.4Principal exclusion criteria
    All Subjects:
    1. Clinically significant unstable neurologic, psychiatric, ophthalmologic, hepatobiliary, respiratory, or hematologic illness or unstable cardiovascular disease (e.g. severe hypotension, uncontrolled cardiac arrhythmia, or myocardial infarction) or any other concurrent disease during the preceding study (for rollover subjects) that in the opinion of the investigator would interfere with study participation or assessment of safety and tolerability
    2. Subjects who are at risk of suicide as defined by their responses to the Columbia-Suicide Severity Rating Scale (C-SSRS) or in the opinion of the investigator. Note: Subjects answering ?yes? to any of the questions about active suicidal ideation/intent/behaviors occurring within the past 12 months must be excluded (C-SSRS Suicide Ideation section ? Questions 3, 4, or 5; C-SSRS Suicidal Behavior section, any of the suicide behaviors questions). Such subjects should be referred immediately to a mental health professional for appropriate evaluation.
    3. Subjects who are unlikely to comply with the protocol (e.g. uncooperative attitude, inability to return for subsequent visits) and/or otherwise considered by the investigator to be unlikely to complete the study
    4. Subjects with severe or uncontrolled depression that, in the judgment of the investigator, makes the subject inappropriate for entry into the study
    5. Subjects with pain due to other conditions (e.g. diabetic peripheral neuropathic pain or post-herpetic neuralgia) that, in the opinion of the investigator, would confound assessment or self-evaluation of the pain associated with FM
    6. Subjects with pain due to any widespread inflammatory musculoskeletal disorder (e.g. rheumatoid arthritis, lupus) or widespread rheumatic disease other than FM.
    7. Abuse or dependence of prescription medications, street drugs, or alcohol within the last 1 year
    8. Any history of a malignancy other than basal cell carcinoma within the past 5 years
    9. A diagnosis of untreated sleep apnea or initiation of treatment for sleep apnea within the past 3 months
    10. Known hypersensitivity to ?2? ligands or other components of the study medications
    11. Pregnancy or breast-feeding, or intent to become pregnant during the study period
    12. Abnormal investigative tests (i.e. ECGs) and laboratory values judged by the investigator to be clinically significant at the End-of-Treatment visit (Visit 11, Week 13) in the preceding study (for rollover subjects), with particular focus on:
    ? Abnormal renal function defined as calculated CrCl < 60 mL/min determined by the central laboratory using the Cockcroft-Gault equation(4); blood urea nitrogen> 1.5 × ULN; serum creatinine > 1.6 mg/dL (> 141.4 ?mol/L); or
    ? Abnormal liver function defined as AST (SGOT) > 2.0 × ULN, ALT (SGPT) > 2.0 × ULN; alkaline phosphatase > 1.5 × ULN; total bilirubin> 1.2 × ULN. If a subject has total bilirubin > 1.2 ULN, unconjugated and conjugated bilirubin fractions should be analyzed and only subjects documented to have Gilbert?s syndrome may be enrolled.; or
    ? creatine kinase> 3.0 × ULN.
    Todos los sujetos
    1. Enfermedad neurológica, psiquiátrica, oftalmológica, hepatobiliar, respiratoria o hematológica inestable clínicamente significativa o enfermedad cardiovascular inestable (como hipotensión grave, arritmia cardiaca no controlada, o infarto de miocardio) o cualquier otra enfermedad concurrente durante el estudio previo (para los sujetos transferidos) o en los 12 meses previos a la selección (para sujetos de novo) que, en opinión del investigador, interferiría con la participación en el estudio o la evaluación de la seguridad y la tolerabilidad.
    2. Sujetos que tengan riesgo de cometer suicidio según se define por sus respuestas en la escala de Columbia de clasificación de intensidad de las ideas suicidas (Columbia-Suicide Severity Rating Scale, C-SSRS) o en opinión del investigador. Nota: los sujetos que respondan ?sí? a alguna de las preguntas sobre pensamientos/intenciones/comportamientos suicidas activos dentro de los últimos 12 meses deben quedar excluidos (sección de pensamientos suicidas de la C-SSRS: preguntas 3, 4 o 5; sección de comportamiento suicida de la C-SSRS, cualquiera de las preguntas sobre comportamiento suicida). Se debe derivar a estos sujetos inmediatamente a un profesional de la salud mental para una evaluación apropiada.
    3. Sujetos que probablemente no cumplirán con el protocolo (p. ej., debido a una actitud poco cooperativa, a la imposibilidad de regresar para visitas posteriores) o que, de otro modo, el investigador considere que probablemente no completarán el estudio.
    4. Los sujetos con depresión grave o no controlada que, a juicio del investigador, haga que no sea apropiada la entrada de los sujetos en el estudio.
    5. Sujetos con dolor debido a otras afecciones (p. ej., dolor neuropático periférico de la diabetes o neuralgia posherpética) que, en opinión del investigador, confundiría la evaluación o la autoevaluación del dolor asociado a la FM.
    6. Sujetos con dolor debido a cualquier trastorno musculoesquelético inflamatorio generalizado (p. ej., artritis reumatoide, lupus) o una enfermedad reumática generalizada que no sea la FM.
    7. Abuso o dependencia de medicamentos con receta, drogas ilegales o alcohol en el último año.
    8. Cualquier antecedente de neoplasia maligna distinto de carcinoma de células basales dentro de los últimos 5 años.
    9. Diagnóstico de apnea del sueño no tratada o inicio de un tratamiento para la apnea del sueño en los últimos 3 meses.
    10. Hipersensibilidad conocida a ligandos alfa2-delta (?2?) o a otros componentes de los medicamentos del estudio.
    11. Embarazo o lactancia, o intención de quedarse embarazada durante el periodo del estudio.
    12. Anomalías en las pruebas de investigación (es decir, ECG) y los valores analíticos evaluados por el investigador como clínicamente significativos en la visita de fin de tratamiento (visita 11, semana 13) en el estudio previo, con especial atención a:
    ? Función renal anómala, definida como un aclaramiento de creatinina (AcCr) calculado <60 ml/min determinado por el laboratorio central utilizando la ecuación de Cockcroft-Gault; nitrógeno ureico en sangre >1,5 x el límite superior de la normalidad (LSN); creatinina sérica >1,6 mg/dl (>141,4 ?mol/l); o
    ? Función hepática anómala, definida como aspartato aminotransferasa (AST) >2,0 x LSN, alanina aminotransferasa (ALT) >2,0 x LSN; fosfatasa alcalina >1,5 x LSN y bilirrubina total >1,2 x LSN. Si un sujeto tiene una bilirrubina total >1,2 LSN, se deben analizar las fracciones conjugadas y no conjugadas de la bilirrubina y solo se puede inscribir a los sujetos con el síndrome de Gilbert documentado; o
    ? Creatina-cinasa >3,0 × LSN.
    E.5 End points
    E.5.1Primary end point(s)
    Long-term safety based on assessment of treatment-emergent adverse events (TEAEs), clinical laboratory evaluations, physical examinations, electrocardiograms (ECGs), the Columbia-Suicide Severity Rating Scale (C-SSRS), and the Physician Withdrawal Checklist (PWC)
    la seguridad a largo plazo basada en la evaluación de acontecimientos adversos emergentes del tratamiento (AAET), las evaluaciones analíticas clínicas, las exploraciones físicas, los electrocardiogramas (ECG), la C-SSRS y la lista de verificación de síntomas de abstinencia (Physician Withdrawal Checklist, PWC).
    E.5.1.1Timepoint(s) of evaluation of this end point
    from the screening/baseline visit to
    the end of treatment visit (ECGs) / end of the follow-up visit (TEAEs, C-SSRS, PWC) / early termination visit
    Desde la visita de selección/inicio hasta el fin de la visita de tratamiento (ECGs) / fin de la visita de seguimiento (TEAEs, C-SSRS, PWC) / visita de finalización prematura
    E.5.2Secondary end point(s)
    ? Changes from baseline to scheduled timepoint in ADPS and ADSIS
    ? Proportion of subjects with improvement in overall status at Week 52 as assessed by PGIC
    ? Changes from baseline to Week 52 in HADS depression and anxiety scores
    ? Changes in EQ-5D and SF-36 parameters from baseline to Week 52
    ? Cambios desde el inicio hasta el momento programado en ADPS y ADSIS.
    ? Proporción de sujetos con una mejoría en el estado general en la semana 52 según la PGIC.
    ? Cambios desde el inicio hasta la semana 52 en las puntuaciones de depresión y ansiedad de HADS.
    ? Cambios en los parámetros de EQ-5D y SF-36 desde el inicio hasta la semana 52.
    E.5.2.1Timepoint(s) of evaluation of this end point
    ? Changes from baseline to scheduled timepoint in ADPS and ADSIS:
    from baseline visit to end of treatment (Week 52)/early termination visit
    ? Proportion of subjects with improvement in overall status at Week 52 as assessed by PGIC:
    at end of treatment (Week 52)/early termination visit
    ? Changes from baseline to Week 52 in HADS depression and anxiety scores:
    from baseline visit to end of treatment (Week 52)/early termination visit
    ? Changes in EQ-5D or SF-36 parameters from baseline to Week 52:
    from baseline visit to end of treatment (Week 52)/early termination visit
    ? Cambios desde el inicio hasta el momento programado en ADPS y ADSIS.
    Desde la visita de inicio hasta la visita de fin del tratamiento (Semana 52)/visita de terminación prematura
    ? Proporción de sujetos con una mejoría en el estado general en la semana 52 según la PGIC.
    En la visita de fin del tratamiento (Semana 52)/visita de terminación prematura
    ? Cambios desde el inicio hasta la semana 52 en las puntuaciones de depresión y ansiedad de HADS.
    Desde la visita de inicio hasta la visita de fin del tratamiento (Semana 52)/visita de terminación prematura
    ? Cambios en los parámetros de EQ-5D y SF-36 desde el inicio hasta la semana 52.
    Desde la visita de inicio hasta la visita de fin del tratamiento (Semana 52)/visita de terminación prematura
    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 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. 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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned23
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA268
    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
    Czech Republic
    New Zealand
    Puerto Rico
    Russian Federation
    South Africa
    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
    Ultima visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months3
    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: 924
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 231
    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 state43
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 277
    F.4.2.2In the whole clinical trial 1155
    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)
    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 Decision2015-06-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-04-19
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2022 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice