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    Summary
    EudraCT Number:2015-002379-81
    Sponsor's Protocol Code Number:CLN-PXT3003-03
    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:2017-04-07
    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 number2015-002379-81
    A.3Full title of the trial
    International, multi-center, double blind 9-month FOLLOW-UP extension study assessing the long term safety and tolerability of PXT3003 in patients with Charcot-Marie-Tooth Disease type 1A.
    Estudio de extensión del seguimiento internacional, multicéntrico, doble ciego de 9 meses de duración para evaluar la seguridad y tolerabilidad a largo plazo de PXT3003 en pacientes con enfermedad de Charcot-Marie-Tooth de tipo 1A.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An International, multi-center, 9-month FOLLOW-UP extension study to study the long term safety of PXT3003 in patients with Charcot-Marie-Tooth Disease type 1A.
    Estudio internacional, multicéntrico de extensión del seguimiento de 9 meses para estudiar la seguridad a largo plazo de PXT3003 en pacientes con enfermedad de Charcot-Marie-Tooth de tipo 1A.
    A.4.1Sponsor's protocol code numberCLN-PXT3003-03
    A.5.4Other Identifiers
    Name:US INDNumber:122505
    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 SponsorPharnext
    B.1.3.4CountryFrance
    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 supportPharnext
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPharnext
    B.5.2Functional name of contact pointAgnes Daoust
    B.5.3 Address:
    B.5.3.1Street Address11, rue des Peupliers
    B.5.3.2Town/ cityIssy-Les-Moulineaux
    B.5.3.3Post code92130
    B.5.3.4CountryFrance
    B.5.4Telephone number+34916307447
    B.5.5Fax number33141092231
    B.5.6E-mailadaoust@pharnext.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/14/1260
    D.3 Description of the IMP
    D.3.2Product code PXT3003 Dose 1
    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 INNBACLOFEN
    D.3.9.1CAS number 1134-47-0
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB05667MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.6
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNALTREXONE
    D.3.9.1CAS number 16676-29-2
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNALTREXONE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB14629MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.07
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSorbitol
    D.3.9.1CAS number 50-70-4
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameD-SORBITOL
    D.3.9.4EV Substance CodeSUB20837
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number21
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/14/1260
    D.3 Description of the IMP
    D.3.2Product code PXT3003 Dose 2
    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 INNBACLOFEN
    D.3.9.1CAS number 1134-47-0
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB05667MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNALTREXONE
    D.3.9.1CAS number 16676-29-2
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNALTREXONE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB14629MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.14
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSorbitol
    D.3.9.1CAS number 50-70-4
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameD-SORBITOL
    D.3.9.4EV Substance CodeSUB20837
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number42
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Charcot-Marie-Tooth Disease type 1A
    Enfermedad de Charcot-Marie-Tooth de tipo 1A
    E.1.1.1Medical condition in easily understood language
    Charcot-Marie-Tooth Disease type 1A
    Enfermedad de Charcot-Marie-Tooth de tipo 1A
    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 19.1
    E.1.2Level LLT
    E.1.2Classification code 10008414
    E.1.2Term Charcot-Marie-Tooth disease
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of the study is to assess the long-term safety and tolerability of PXT3003 up to 2 years, and to increase the exposed population receiving PXT3003 for at least 9 months.
    El objetivo principal del estudio es evaluar la seguridad y la tolerabilidad a largo plazo de PXT3003 durante un máximo de 2 años, así como aumentar la población de pacientes expuestos que reciban PXT3003 durante al menos 9 meses.
    E.2.2Secondary objectives of the trial
    To gather up-to-2-year data to estimate the long term effect of PXT3003 on clinical, functional and electrophysiological endpoints;
    - To compare the effect of PXT3003 in patients receiving PXT3003 active dose from the start of the primary study to patients assigned to a delayed start (i.e., who received placebo during the primary study) in order to show if PXT3003 slows the progression of the disease
    - To assess the evolution of potential blood biomarkers and molecular changes in skin biopsy on longer term.
    - Recopilar datos de hasta 2 años para calcular el efecto a largo plazo de PXT3003 en los criterios de valoración clínicos, funcionales y lectrofisiológicos
    - Comparar el efecto de PXT3003 en pacientes que reciben una dosis activa de PXT3003 desde el principio del estudio principal con pacientes asignados a un inicio tardío (es decir, los que recibieron placebo durante el estudio principal) a fin de demostrar si PXT3003 ralentiza la progresión de la enfermedad
    - Evaluar la evolución de posibles biomarcadores sanguíneos y cambios moleculares en la biopsia de piel a largo plazo.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    - Skin Biopsy (ancillary sub-study) for molecular biology will be done at the end of the study (9-month visit)
    - MRI measure (ancillary sub-study) of muscle/fat index in the leg (by MRI quantification of lower limb muscles and fatty muscle infiltration) will be performed at the end of the study (9-month visit).
    - Biopsia de piel (sub-estudio opcional) para biología molecular, que se hará al final del estudio (visita de los 9 meses)
    - RMN (sub-estudio opcional) de músculo/índice de grasa en la pierna (por RMN de cuantificación en los músculos de las extremidades inferiores e infiltración de grasa en los músculos), que se hará al final del estudio (visita de los 9 meses)
    E.3Principal inclusion criteria
    Male or female patients with all of the following inclusion criteria will be considered for randomization:
    1. Patient previously randomized to the initial PLEO-CMT study (protocol CLN-PXT3003-02) and having completed 15 months of double-blind treatment in that study, including all procedures required at the Study Termination visit (V6)
    2. Patient providing a signed written informed consent to participate in the extension study and willing and able to comply with all study procedures and scheduled visits.
    3. Female patients must agree to continue using an approved method of birth control throughout the extension study
    Pacientes varones o mujeres con todos los siguientes criterios de inclusión para ser considerados para aleatorización en el ensayo:
    - Los pacientes deben haber recibido tratamiento doble ciego durante 15 meses en el estudio principal CLN-PXT3003-02, incluidos todos los procedimientos necesarios en la
    visita de finalización del estudio (V6).
    - Las pacientes deberán aceptar seguir utilizando un método anticonceptivo aprobado a lo largo de todo el estudio de extensión.
    - Para participar en este estudio, los pacientes deberán firmar un consentimiento informado por escrito, específico para el estudio de extensión. En el caso de menores de entre 16 y 18 años, deberá recogerse el consentimiento tanto del padre/madre como del menor.
    E.4Principal exclusion criteria
    Patients with any of the following criteria will be excluded from entry:
    1. Presenting any clinically significant change in health status that, in the opinion of the Investigator, would prevent the subject from participating in this study or successfully completing this study.
    2. Any unauthorized concomitant treatments, as study CLN-PXT3003-02.
    Los pacientes con alguno de los siguientes criterios serán excluidos
    - Todo cambio clínicamente significativo en el estado de salud que, a criterio del investigador, impediría que el paciente participara en el estudio o que lo finalizara de forma satisfactoria.
    - Todo tratamiento concomitante no autorizado, como en el estudio CLN-PXT3003-02
    E.5 End points
    E.5.1Primary end point(s)
    To assess the safety and tolerability of PXT3003 in CMT1A patients during a long term period, the primary endpoint will be the incidence of Treatment-Emergent Adverse Events (TEAEs) Related to the Investigational Product during the follow-up, in patients exposed to PXT3003 for 24 months or 9 months.
    The incidence of TEAEs in the two groups P / D1-9m and P/ D2-9m will be compared to the first 9-month placebo period in the primary study.
    The incidence of TEAEs in the two groups D1-24m, D2-24m will be compared to the first 9-month period in the primary study for their corresponding group.
    Evaluar la seguridad y tolerabilidad de PXT3003 en pacientes con CMT1A durante un período prolongado. El criterio de valoración principal será la incidencia de acontecimientos adversos de aparición durante el tratamiento (AAAT) relacionados con el producto en investigación durante el seguimiento en pacientes expuestos a PXT3003 durante 24 meses o 9 meses.
    La incidencia de AAAT en los dos grupos P/D1-9m y P/D2-9m se comparará con el primer período con placebo de 9 meses del estudio principal.
    La incidencia de AAAT en los dos grupos D1-24m y D2-24m se comparará con el primer período de 9 meses del estudio principal para el grupo correspondiente.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The incidence of TEAEs in the two groups P/ D1-9m and P / D2-9m will be compared to the first 9-month placebo period in the primary study.
    The incidence of TEAEs in the two groups D1-24m, D2-24m will be compared to the first 9-month period in the primary study for their corresponding group
    La incidencia de AAAT en los dos grupos P/D1-9m y P/D2-9m se comparará con el primer período con placebo de 9 meses del estudio principal.
    La incidencia de AAAT en los dos grupos D1-24m y D2-24m se comparará con el primer período de 9 meses del estudio principal para el grupo correspondiente.
    E.5.2Secondary end point(s)
    Secondary safety endpoints will be:
    - The incidence of all Treatment-Emergent Adverse Events (TEAEs) and evaluation of their type/nature, severity/intensity, seriousness, duration, relationship to study drug, and outcome;
    - The incidence of AEs leading to withdrawal of study drug;
    - The changes in laboratory parameters, ECGs, vital signs and physical examinations;
    Se evaluarán otros criterios de valoración de la seguridad:
    - Incidencia de todos los AAAT y su evaluación en cuanto a tipo/naturaleza, intensidad,
    gravedad, duración, relación con el fármaco del estudio y desenlace;
    - Incidencia de AA que den lugar a la retirada del fármaco del estudio;
    - Cambio en los parámetros analíticos, ECG, constantes vitales y exploraciones físicas;
    E.5.2.1Timepoint(s) of evaluation of this end point
    For the patients receiving 24 months of active dose along the two successive studies (from groups D1-24m and D2-24m) the clinical response will be assessed by the change from V1/baseline of each endpoint.
    For the patients who received placebo during the 15-month primary study and active drug during the 9-month extension study (from groups P/D1-9m and P/D2-9m) the clinical response will be assessed after 9 months of PXT3003 treatment by the change from V6/baseline.
    The Percentage of responders to PXT3003 defined as a patients improving on ONLS at end of treatment (V9) will be assessed in the patients receiving the active dose of PXT3003 during 24 months (from groups D1-24m, D2-24m).
    Par los pacientes que reciban 24 meses de dosis activa en los 2 estudios sucesivos (de los grupos D1-24m y D2-24m), la respuesta clínica se evaluará mediante el cambio respecto a la V1/inicio de cada criterio de valoración.
    Par los pacientes que recibieron placebo durante el estudio principal de 15 meses y fármaco activo durante el estudio de extensión de 9 meses grupos P/D1-9m y P/D2-9m), la respuesta clínica se evaluará tras 9 meses de tratamiento con PXT3003 mediante el cambio respecto a la V6/inicio
    El % de pacientes con respuesta a PXT3003, definido como los pacientes cuya puntuación en ONLS mejora al final del tratamiento (V9), se evaluará en los pacientes que reciben la dosis activa de PXT3003 durante 24 meses (de los grupos D1-24m y D2-24m)
    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.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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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 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 Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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
    Belgium
    Canada
    France
    Germany
    Netherlands
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    Última Visita del último paciente
    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 months8
    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 months8
    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: 30
    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: 30
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 270
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 state62
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    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 Decision2017-05-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-11
    P. End of Trial
    P.End of Trial StatusOngoing
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