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    Summary
    EudraCT Number:2018-001639-35
    Sponsor's Protocol Code Number:M602011014
    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:2019-06-11
    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 number2018-001639-35
    A.3Full title of the trial
    Prospective, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of NT 201 in the treatment of lower limb spasticity caused by stroke or traumatic brain injury in adult subjects, followed by an open label extension with or without combined upper limb treatment
    Estudio prospectivo, aleatorizado, doble ciego, controlado con placebo y multicéntrico para investigar la eficacia y la seguridad de NT 201 en el tratamiento de la espasticidad de la extremidad inferior debido a un ictus o a un traumatismo craneoencefálico en sujetos adultos, seguido de una extensión abierta con o sin tratamiento combinado para la extremidad superior.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to compare the efficacy and safety of NT 201 (botulinum toxin) with placebo for the treatment of lower limb spasticity caused by stroke or traumatic brain injury.
    Estudio comparativo de la eficacia y la seguridad de NT 201 (toxina botulínica) frente a placebo en el tratamiento de la espasticidad de la extremidad inferior debida a un ictus o a un traumatismo craneoencefálico
    A.3.2Name or abbreviated title of the trial where available
    PATTERN (Multi-PAttern TreaTment of uppEr and loweR limb with iNcobotulinumtoxinA)
    PATTERN (tratamiento multi-PATrón de las exTrEmidades supeRiores e inferiores con iNcobotulinumtoxin
    A.4.1Sponsor's protocol code numberM602011014
    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 SponsorMerz Pharmaceuticals GmbH
    B.1.3.4CountryGermany
    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 supportMerz Pharmaceutical GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerz Pharmaceuticals GmbH
    B.5.2Functional name of contact pointPublic Disclosure Manager
    B.5.3 Address:
    B.5.3.1Street AddressEckenheimer Landstraße 100
    B.5.3.2Town/ cityFrankfurt/Main
    B.5.3.3Post code60318
    B.5.3.4CountryGermany
    B.5.4Telephone number+496915030
    B.5.5Fax number+49691503200
    B.5.6E-mailclinicaltrials@merz.de
    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 Yes
    D.2.1.1.1Trade name Xeomin
    D.2.1.1.2Name of the Marketing Authorisation holderMerz Pharmaceuticals GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameNT 201
    D.3.2Product code NT 201
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBotulinum-Toxin Type A
    D.3.9.1CAS number 93384-43-1
    D.3.9.2Current sponsor codeNT 101
    D.3.9.3Other descriptive nameCLOSTRIDIUM BOTULINUM NEUROTOXIN TYPE A (150KD), FREE OF COMPLEXING PROTEINS
    D.3.9.4EV Substance CodeSUB26174
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number800
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeNeurotoxin
    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 placeboPowder for solution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Diagnosis of lower limb spasticity with or without upper limb spasticity of the same body side caused by stroke or traumatic brain injury
    Diagnóstico de la espasticidad de extremidad inferior, con o sin espasticidad de extremidad superior del mismo lado del cuerpo, debida a ictus o traumatismo craneoencefálico
    E.1.1.1Medical condition in easily understood language
    Lower limb or combined lower limb and upper limb spasticity due to stroke or traumatic brain injury
    Espasticidad de extremidad inferior o combinada de extremidades inferior y superior debida a ictus o traumatismo craneoencefálico
    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 10058977
    E.1.2Term Spastic paresis
    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
    Evaluation of the efficacy and safety of 400 U of NT 201 in the treatment of adult lower limb spasticity involving the ankle plantar flexors.
    evaluar la eficacia y la seguridad de 400 unidades [U] de NT 201 en el tratamiento de la espasticidad de la extremidad inferior en adultos que afecta a los músculos flexores plantares del tobillo.
    E.2.2Secondary objectives of the trial
    Evaluation of the long-term safety of NT 201 in the treatment of spasticity with total body doses up to 800 U.
    evaluar la seguridad a largo plazo de NT 201 en el tratamiento de la espasticidad con dosis corporales totales de hasta 800 U.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Main inclusion criteria
    • Female or male subject ≥ 18 years and ≤ 85 years at screening
    • Diagnosis of lower limb spasticity with or without upper limb spasticity of the same body side caused by stroke or traumatic brain injury
    • Disabling ankle flexor spasticity presenting as pes equinus or pes equinovarus
    • Modified Ashworth Scale-Bohannon [MAS] score of 2 or 3 points in the ankle plantar flexor of the target lower limb (supine position, knee extended)
    • Minimum passive range of motion in ankle of the target lower limb (supine position, knee extended): 10°dorsiflexion and 20°plantarflexion
    • At least 4 months since last botulinum neurotoxin [BoNT] injection for treatment of spasticity or any other condition
    • For subjects receiving anticoagulation therapy, the investigator confirms and documents that the subject has an:
    o Activated partial thromboplastin time [aPTT] ≤ 80 seconds (subjects on dabigatran or other direct thrombin inhibitors) or
    o International normalized ratio [INR] value of ≤ 2.5 (subjects on coumarins or other anticoagulants monitored by INR)

    Main eligibility criteria for re-injection
    • According to the experience-based opinion of the investigator, the subject must have a clinical need for 400 U of NT 201 in the affected lower limb
    • Body weight at least 50 kg
    • Negative urine pregnancy test for women of childbearing potential
    • For subjects receiving anticoagulation therapy, the investigator confirms and documents that the subject has an:
    o aPTT ≤ 80 seconds (subjects on dabigatran or other direct thrombin inhibitors) or
    o INR value of ≤ 2.5 (subjects on coumarins or other anticoagulants monitored by INR)
    • No infection or inflammation in the area of the planned injection sites at the visits
    Criterios principales de inclusión
    •Hombres o mujeres ≥18 años y ≤85 años en la selección.
    •Diagnóstico de espasticidad de la extremidad inferior con o sin espasticidad de la extremidad superior del mismo lado del cuerpo debido a un ictus o a un traumatismo craneoencefálico.
    •Espasticidad discapacitante de los músculos flexores del tobillo que se presenta en forma de pie equino o pie equinovaro.
    •Puntuación en la Escala de Ashworth modificada por Bohannon [MAS] de 2 o 3 puntos en los músculos flexores plantares del tobillo de la extremidad inferior diana (posición supina, rodilla extendida).
    •Rango de movimiento pasivo mínimo del tobillo de la extremidad inferior diana (posición supina, rodilla extendida): 10° de flexión dorsal y 20° de flexión plantar.
    •Al menos 4 meses desde la última inyección de neurotoxina botulínica [BoNT] para el tratamiento de la espasticidad o cualquier otra afección.
    •En los sujetos que reciben tratamiento anticoagulante, el investigador debe confirmar y documentar que el sujeto tiene:
    o Tiempo parcial de tromboplastina activado [aPTT] ≤80 segundos (sujetos que reciben dabigatrán u otros inhibidores directos de trombina) o
    o Ratio internacional normalizada [INR] ≤2,5 (sujetos que reciben cumarínicos u otros anticoagulantes con control de la INR)
    Criterios principales de selección para la repetición de la inyección
    •Según la opinión basada en la experiencia del investigador, el sujeto debe tener una necesidad clínica de 400 U de NT 201 en la extremidad inferior afectada.
    •Peso corporal mínimo de 50 kg.
    •Resultado negativo en la prueba de embarazo en orina en las mujeres en edad fértil.
    •En los sujetos que reciben tratamiento anticoagulante, el investigador debe confirmar y documentar que el sujeto tiene:
    o aPTT ≤80 segundos (sujetos que reciben dabigatrán u otros inhibidores directos de trombina) o
    o INR ≤2,5 (sujetos que reciben cumarínicos u otros anticoagulantes con control de la INR)
    •Sin infección o inflamación en los lugares de inyección previstos en las visitas.
    E.4Principal exclusion criteria
    Main exclusion criteria
    • Generalized disorders of muscle activity (e.g. myasthenia gravis, Lambert Eaton syndrome, amyotrophic lateral sclerosis) or any other significant peripheral neuromuscular dysfunction which might interfere with the study
    • Bilateral lower limb paresis/paralysis/spasticity or tetraparesis/paralysis/spasticity
    • Body weight < 50 kg
    • Severe atrophy of the target limb muscles
    • Previous, ongoing or planned treatments of spasticity with intrathecal baclofen
    • Previous, ongoing, or planned treatments of spasticity in the target lower limb with any of the following procedures:
    o Surgical intervention
    o Alcohol or phenol block
    o Muscle afferent block
    • Physiotherapy or use of orthoses or splints at the target limb initiated less than 4 weeks before screening or expected to change during the double blind phase of the study
    • Current or planned treatment with parenterally administered drugs that interfere with neuromuscular transmission (e.g. intrathecal baclofen, tubocurarine type muscle relaxants used in anesthesia),, or local anesthetics in the treated region within 2 weeks prior to screening
    • Infection or inflammation at the injection sites
    • Subjects with presence or history of aspiration pneumonia, recurrent lower respiratory tract infections, or compromised respiratory function as per investigator's clinical judgment
    • Pregnancy (as verified by a positive pregnancy test) or breast feeding
    Criterios principales de exclusión
    • Trastornos generalizados de la actividad muscular (p. ej. miastenia grave, síndrome de Lambert Eaton, esclerosis lateral amiotrófica) u otra disfunción neuromuscular periférica significativa que pudiera interferir en el estudio.
    •Paresia/parálisis/espasticidad bilateral de las extremidades inferiores o tetraparesia/parálisis/espasticidad.
    •Peso corporal <50 kg.
    •Atrofia grave de los músculos de la extremidad diana.
    •Tratamientos previos, en curso o previstos para la espasticidad con baclofeno intratecal.
    •Tratamientos previos, en curso o previstos para la espasticidad de la extremidad inferior diana con alguna de las intervenciones siguientes:
    o intervención quirúrgica
    o bloqueo con alcohol o fenol
    o bloqueo muscular aferente
    • Fisioterapia o uso de ortesis o férulas en la extremidad diana que se inicia menos de 4 semanas antes de la selección o que se espera que cambie durante la fase doble ciego del estudio.
    • Tratamiento actual o previsto con medicamentos administrados por vía parenteral que interfieren en la transmisión neuromuscular (p. ej., baclofeno intratecal, relajantes musculares de tipo tubocurarina utilizados en la anestesia) o anestésicos locales en la zona tratada en las 2 semanas anteriores a la selección.
    • Infección o inflamación en los lugares de inyección.
    • Sujetos con presencia o antecedentes de neumonía por aspiración, infecciones recurrentes en las vías respiratorias bajas o insuficiencia respiratoria según la opinión clínica del investigador.
    • Embarazo (verificado mediante un resultado positivo en la prueba de embarazo) o periodo de lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    Co-primary efficacy variables:
    • Change from baseline in derived Modified Ashworth Scale-Bohannon (MAS) ankle score (knee extended)
    • Global Impression of Change Scale (GICS) assessed by physician

    Primary safety variable:
    Occurrence of treatment emergent adverse events [TEAEs] in Main Period
    Criterios de valoración co-principales de la eficacia:
    • Cambio frente a la Visita Basal en la puntuación de la Escala de Ashworth modificada por Bohannon [MAS] en tobillo (con rodilla extendida)
    • Global Impression of Change Scale (GICS), evaluada por el médico

    Criterio principal de valoración de la seguridad:
    • Aparición de acontecimientos adversos emergentes durante el tratamiento (treatment emergent adverse events, TEAEs] en el Periodo Principal
    E.5.1.1Timepoint(s) of evaluation of this end point
    Timepoints of evaluation of Co-primary efficacy variables:
    • Modified Ashworth Scale-Bohannon (MAS) ankle score at Weeks 4 to 6
    • Global Impression of Change Scale (GICS) assessed at Week 4 to 6

    Timepoint of evaluation of the primary safety variable:
    • During Main Period
    Momentos de evaluación de los criterios co-principales de valoración de la eficacia:
    • Puntuación de la Escala de Ashworth modificada por Bohannon [MAS] en tobillo en las Semanas 4 a 6
    • Global Impression of Change Scale (GICS) en las Semanas 4 a 6
    Momento de evaluación del criterio principal de valoración de la seguridad:
    • Durante el Periodo Principal
    E.5.2Secondary end point(s)
    Key secondary efficacy variable:
    • Change from Study Baseline in Goal Attainment Scale [GAS]

    Other secondary efficacy variables:
    • Global Impression of Change Scale (GICS) assessed by subject
    • Global Impression of Change Scale (GICS) assessed by caregiver
    Criterio de valoración secundario clave de la eficacia:
    • Cambio frente a la Visita Basal del estudio en la Goal Attainment Scale [GAS]

    Otros criterios de valoración secundarios de la eficacia:
    • Global Impression of Change Scale (GICS) evaluada por el sujeto
    • Global Impression of Change Scale (GICS) evaluada por el cuidador
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Goal Attainment Scale [GAS] at Week 6 (V4)
    • GICS assessed by subject at Week 4 (V3) to Week 6 (V4).
    • GICS assessed by caregiver at Week 4 (V3) to Week 6 (V4).
    • Goal Attainment Scale [GAS] en la Semana 6 (V4)
    • GICS evaluada por el sujeto desde la Semana 4 (V3) a la Semana 6 (V4).
    • GICS evaluada por el cuidador desde la Semana 4 (V3) a la Semana 6 (V4)
    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 Yes
    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 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 Yes
    E.8.1.7.1Other trial design description
    Diseño adaptativo en dos etapas con re-evaluación intermedia del tamaño de la muestra tras 360 sujet
    Two-stage adaptive design with interim sample size reassessment after 360 subjects (Treatment/OLEX)
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA59
    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
    Australia
    Belgium
    Canada
    Czech Republic
    France
    Germany
    Italy
    Norway
    Poland
    Portugal
    Russian Federation
    Spain
    Switzerland
    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
    The End of the entire study, is defined as the date of attendance of the last subject of the final visit of the OLEX period (V17 for subjects with five cycles or V20 with six cycles).
    Última visita del último sujeto.
    El final de todo el estudio se define como la fecha de la visita final del último sujeto del periodo OLEX (V17 en los sujetos con cinco ciclos o V20 en los sujetos con seis ciclos).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 540
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 374
    F.4.2.2In the whole clinical trial 600
    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
    After study discontinuation, the subjects will be treated by their physician according to their medical condition and standard treatments in the country concerned.
    Ninguno
    Tras la salida del estudio, los sujetos serán tratados por su médico en función de su estado y de los tratamientos habituales en su país
    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 Decision2019-07-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-07
    P. End of Trial
    P.End of Trial StatusOngoing
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