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    Summary
    EudraCT Number:2010-022486-10
    Sponsor's Protocol Code Number:MT-102-2001
    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:2011-12-21
    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 number2010-022486-10
    A.3Full title of the trial
    A multicentre, randomised, double-blind, placebo-controlled, dose-finding phase II clinical study to evaluate the efficacy of two different doses of MT-102 administered over a sixteen week period in subjects with cachexia related to stage III and IV non-small cell lung cancer and colorectal cancer
    Estudio clínico de fase II, multicéntrico, aleatorizado, en doble ciego, controlado con placebo y de búsqueda de dosis, para evaluar la eficacia de dos dosis diferentes de MT-102 administrado a lo largo de un periodo de 16 semanas en sujetos con caquexia por cáncer de pulmón no microcítico y cáncer colorrectal en estadios III y IV
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A research study of a new drug (MT-102) for patients with weight loss and weakness (cachexia) related to lung or colorectal cancer
    Estudio en investigación de un nuevo fármaco (MT-102) en pacientes con pérdida de peso y debilidad (caquexia) relacionados con cáncer de pulmón o colorectal
    A.4.1Sponsor's protocol code numberMT-102-2001
    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 SponsorPsioxus Therapeutics Limited
    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 supportBrecon Pharmaceuticals Ltd
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportQuintiles Limited, Global Central Lab
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPivotal SL
    B.5.2Functional name of contact pointPaz González
    B.5.3 Address:
    B.5.3.1Street Addressc/Gobelas 19. La Florida
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28023
    B.5.3.4CountrySpain
    B.5.4Telephone number349170815501255
    B.5.5Fax number34917081301NA
    B.5.6E-mailpaz.gonzalez@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 nameMT-102
    D.3.2Product code MT-102
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor codeMT-102
    D.3.9.3Other descriptive nameS-pindolol or espindolol
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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 placeboTablet
    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
    Cachexia related to stage III and IV non-small cell lung cancer and colorectal cancer
    Caquexia relacionada con estadíos III y IV de cáncer de pulmón y colorrectal
    E.1.1.1Medical condition in easily understood language
    Advanced lung and colorectal cancer
    Cáncer de pulmón y colorrectal avanzados
    E.1.1.2Therapeutic area Body processes [G] - Cell Physiological Phenomena [G04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10064015
    E.1.2Term Cancer cachexia
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Demonstrate the effect of a 10mg / bd dose of MT-102 in comparison to placebo on the rate of weight change over a sixteen week period in patients with cachexia related to underlying stage III and stage IV colorectal or non-small cell lung cancer
    Demostrar el efecto de una dosis de 10 mg, dos veces al día, de MT-102, en comparación con un placebo, sobre la tasa de cambio del peso, durante un periodo de 16 semanas, en los pacientes con caquexia, en relación con un cáncer de fondo, colorrectal o cáncer no microcítico de pulmón, en estadios III y IV
    E.2.2Secondary objectives of the trial
    Demonstrate the effects of two different doses of MT-102 in comparison to placebo over a sixteen week period in patients with cachexia related to underlying stage III and stage IV colorectal or non-small cell lung cancer on:
    -the rate of weight change
    -stair climbing power (SCP)
    -the Short Physical Performance Battery test(SPPB)
    -the six minute walk test (SMWT)
    -hand grip strength (HGS)
    -measures of quality of life (QOL) using the EQ-5D questionnaire
    -change of body composition according to Dual Energy X-ray Absorbitometry (DEXA)
    -all cause mortality
    -the adverse event profile
    -Inflammatory, neuroendocrine and catabolic / anabolic biomarkers
    Demostrar los efectos de dos dosis diferentes de MT-102, en comparación con un placebo, durante un periodo de 16 semanas, en pacientes con caquexia, en relación con un cáncer de fondo, colorrectal o cáncer no microcítico de pulmón, en estadios III y IV, sobre:
    - la tasa de cambio de peso;
    - la potencia para subir escaleras (PSE);
    - la prueba de la serie abreviada de rendimiento físico (Short Physical Performance Battery, SPPB);
    - la prueba de marcha durante seis minutos (PM6M);
    - la fuerza del agarre de las manos (FAM);
    - las medidas de la calidad de vida (QoL), mediante el cuestionario EQ-5D;
    - el cambio de la composición corporal, según la absorciometría de rayos X de doble energía (DEXA);
    - la mortalidad por todas las causas;
    - el perfil de acontecimientos adversos;
    - los biomarcadores inflamatorios, neuroendocrinos y catabólicos o anabólicos
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult patients aged between 25 to 80 years of age and with a life expectancy of greater than 3 months as judged by the treating physician.
    2. Confirmed diagnosis of one of:
    a. Non-curative stage III or stage IV Colorectal Cancer (CRC) not suitable for surgery, or
    b. Non-curative stage III or stage IV Non-small Cell Lung Cancer (NSCLC) not suitable for surgery;
    3. Patients who are receiving or who have already received a course of chemotherapy, with or without radiotherapy or surgery, with one of the following regimes:
    a. For non-small cell lung cancer, a platinum based regimen
    b. For colorectal cancer, a 5FU or Irinotecan based regimen
    4. Cachexia with ongoing weight loss that in the opinion of the investigator is due to the underlying cancer.
    5. Evidence of cachexia as judged by one of:
    a. > or equal 5% documented weight loss in the previous 12 months; or
    b. A subjective report of weight loss in the previous 12 months and a recorded body mass index (BMI) less than 20.0 kg/m2
    c. Ongoing documented weight loss of at least 1kg in the week prior to day 0; or 1.25kg in the 2 weeks prior to day 0, or 1.5kg in the 3 to 6 weeks prior to day 0; provided that BMI is not more than 25.
    6. At least two of the following:
    a. Subjective report of decreased muscle strength
    b. Subjective report of fatigue
    c. Subjective report of anorexia
    d. Abnormal biochemistry with one or more of the following:
    i. CRP > ULN (as per Central Lab normal value)
    ii. Anemia (< 12 g/dl)
    iii. Low serum albumin (< 3.2 g/dl)
    7. Patients of childbearing potential must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives; an intrauterine device; male or female condoms; diaphragm or cervical cap with spermicide; or abstinence) prior to randomisation and must agree to continue using such precautions until the end of the 140 day safety follow up;
    8. Willing and able to comply with the protocol and to complete the study period;
    9. Willing to forego other forms of experimental treatment during the study;
    10. Signed and dated informed consent, prior to receipt of any study medication or any study related procedures.
    11. ECOG performance status 0, 1 or 2
    12. Able to complete the performance tests (SCP, SMWT, SPPB, HGS) at the screening visit and with two consecutive pre-randomisation SMWT results that differ by no more than 30% from each other
    13. At least 80% compliant during the placebo run in period
    1. Pacientes adultos, con una edad entre 25 y 80 años, con una expectativa de vida superior a tres meses, según el criterio del médico a cargo del tratamiento;
    2. diagnóstico confirmado de una de las dos siguientes afecciones:
    a. cáncer colorrectal en estadio III o IV, incurable, no adecuado para el tratamiento quirúrgico;
    b. cáncer no microcítico de pulmón, en estadio III o IV, incurable, no adecuado para el tratamiento quirúrgico;
    3. pacientes que están recibiendo o que han ya recibido un ciclo de quimioterapia, con o sin radioterapia o cirugía, con uno de los siguientes esquemas:
    a. para el cáncer no microcítico de pulmón, un esquema basado en platino;
    b. para el cáncer colorrectal, un esquema basado en 5-fluorouracilo o irinotecán;
    4. caquexia, con una pérdida actual que, en opinión, del investigador, se debe al cáncer de fondo;
    5. prueba de caquexia, a juzgar por uno de los siguientes criterios:
    a. > o igual 5% de pérdida de peso comprobada en los 12 meses anteriores;
    b. una notificación subjetiva de pérdida de peso en los 12 meses anteriores y un índice de masa corporal (IMC) registrado inferior a 20,0 kg/m2;
    c. una pérdida de peso comprobada y actual de por lo menos 1 kg en la semana anterior al día 0, de 1,25 kg en las dos semanas anteriores al día 0 o de 1,5 kg en las tres a seis semanas anteriores al día 0, siempre que el IMC no sea superior a 25;
    6. por lo menos dos de los siguientes criterios:
    a. notificación subjetiva de disminución de la fuerza muscular;
    b. notificación subjetiva de cansancio;
    c. notificación subjetiva de anorexia;
    d. valores bioquímicos anormales, con uno o varios de los siguientes criterios:
    i. PCR > LSN (según el valor normal del laboratorio central);
    ii. anemia (< 12 g/dl);
    iii. albúmina sérica baja (< 3,2 g/dl);
    7. las pacientes en edad fértil deben usar un método eficaz para evitar el embarazo (incluidos los anticonceptivos orales, transdérmicos o implantados; un dispositivo intrauterino; condones masculinos o femeninos; diafragma o capuchón cervical con espermicida, o abstinencia) antes de la asignación aleatoria, y deben estar de acuerdo en seguir con el uso de dichas precauciones hasta el final del periodo de seguimiento de la seguridad, durante 140 días;
    8. estar dispuestos y ser capaces de cumplir con el protocolo y finalizar el periodo de estudio;
    9. estar dispuestos a someterse a otras formas de tratamiento experimental durante el estudio;
    10. haber firmado y fechado un consentimiento informado, antes de la recepción de cualquier medicamento del estudio o de cualquier procedimiento relacionado con el estudio;
    11. estado de rendimiento de ECOG 0, 1 o 2;
    12. ser capaz de realizar las pruebas de rendimiento (PSE, PM6M, SPPB, FAM) en la visita de selección y con dos resultados consecutivos de la PM6M, antes de la asignación aleatoria, que difieran en no más del 30% entre sí;
    13. cumplimiento mínimo del 80% durante el periodo de rodaje con un placebo
    E.4Principal exclusion criteria
    1. Pregnancy or lactation at screen or baseline visit;
    2. > or equal 20% weight loss in the previous 3 months or a BMI of less than 16 kg/m2
    3. Age greater than 80 or less than 25 at baseline visit;
    4. Scheduled to start any new course of chemotherapy or to undergo a change in present chemotherapeutic regimen during the dose escalation phase of the study (the first three weeks after randomisation);
    5. Any surgical procedure within the past month or any planned surgical procedure;
    6. Any mechanical obstruction of the alimentary canal;
    7. Any history or evidence of intractable vomiting;
    8. A history or clinical evidence of any hyperthyroidism, cirrhosis, hepatic failure, HIV, renal failure (as determined by a serum creatinine > 250µmol/l or > 2.83 mg/dl at screen) or active tuberculosis (as confirmed by sputum or other microbiological methods, within the last five years);
    9. Any physical, medical, socioeconomic or other non-cancer related cause for simple starvation, muscle wasting or weight loss;
    10. Receiving enteral tube feeding or parenteral nutrition at screening or baseline visit;
    11. Any clinical evidence of ascites or significant oedema or significant pleural effusion at screening or baseline visit;
    12. Current or planned treatment with
    a. Any oral adrenal corticosteroids (inhaled or topical steroids and short-term use of dexamethasone around the time of chemotherapy are acceptable);
    b. Beta adrenergic blockers,
    c. Non-dihydropyridine calcium antagonists (e.g. Verapamil, diltiazem),
    d. Alpha adrenergic blockers,
    e. Ivabradine (Coralan, Procoralan),
    f. 5HT agonists or antagonists e.g. SSRI?s (short-term use around the time of chemotherapy are acceptable),
    g. MAOIs,
    h. Beta agonists (short term or on-and-off use of inhaled broncho-dilators are acceptable),
    i. Amiodarone,
    j. Megestrol, Anabolic Steroids or any other prescription medication intended to increase appetite or to treat unintentional weight loss.
    13. Treatment with any investigational drug therapy within 28 days prior to the screening visit;
    14. Previous history of administration of pindolol or s-pindolol;
    15. History of allergy or reaction to any component of the MT 102/study drug formulation;
    16. History or presence of congestive heart failure (with LVEF <45%) or uncontrolled hypertension (with BP >160/95 mm Hg);
    17. Use of a pacemaker, implantable defibrillator, or internalized metal stent;
    18. Resting pulse rate less than 68 beats per minute or high degree conduction defect on the electrocardiogram;
    19. A resting supine systolic blood pressure less than 100 mm Hg;
    20. A history of bronchospasm and bronchial asthma;
    21. History or diagnosis of brain metastases.
    1. Embarazo o lactancia en la visita de selección o de inicio;
    2. > o igual 20% de pérdida de peso en los tres meses anteriores o un IMC inferior a 16 kg/m2;
    3. edad superior a 80 años o inferior a 25 años en la visita de inicio;
    4. programado para iniciar cualquier ciclo nuevo de quimioterapia o para someterse a un cambio del esquema actual de quimioterapia durante la fase de aumento de la dosis del estudio (las tres primeras semanas después de la asignación aleatoria);
    5. cualquier intervención quirúrgica durante el último mes o cualquier intervención quirúrgica planificada;
    6. cualquier obstrucción mecánica del tubo digestivo;
    7. cualquier antecedente o prueba de vómitos intratables;
    8. antecedentes pruebas clínicas de hipertiroidismo, cirrosis, insuficiencia hepática, infección por el VIH, insuficiencia renal (determinada por una creatinina sérica > 250 µmol/l o > 2,83 mg/dl en el periodo de selección) o tuberculosis activa (confirmada mediante el análisis del esputo u otro método microbiológico, en los cinco últimos años);
    9. cualquier causa física, médica, socioeconómica u otra, no relacionada con el cáncer, de inanición simple, atrofia muscular progresiva o pérdida de peso;
    10. recibir alimentación por sonda entérica o nutrición parenteral en la visita de selección o en la de inicio;
    11. cualquier prueba clínica de ascitis o de edema significativo, o derrame pleural significativo, en la visita de selección o en la de inicio;
    12. tratamiento actual o planificado con:
    a. cualquier corticoesteroide suprarrenal por vía oral (son aceptables los esteroides por inhalación o tópicos, y el uso a corto plazo de dexametasona cerca del tiempo de la quimioterapia);
    b. bloqueantes adrenérgicos beta;
    c. antagonistas del calcio no dihidropiridínicos (p. ej., verapamilo, diltiazem);
    d. bloqueantes adrenérgicos alfa;
    e. ivabradina (Coralan, Procoralan);
    f. agonistas o antagonistas de la 5-hidroxitriptamina, p. ej., los inhibidores selectivos de la recaptación de serotonina (es aceptable el uso a corto plazo cerca del tiempo de la quimioterapia);
    g. IMAO;
    h. agonistas beta (es aceptable el uso a corto plazo o intermitente de broncodilatadores por inhalación);
    i. amiodarona;
    j. megestrol, esteroides anabolizantes o cualquier otro medicamento de venta con receta, indicado para aumentar el apetito o para tratar la pérdida no intencionada de peso;
    13. tratamiento con cualquier medicamento en investigación en los 28 días anteriores a la visita de selección;
    14. antecedentes de administración de pindolol o de S-pindolol;
    15. antecedentes de alergia o reacción a cualquier componente de MT 102 / formulación del fármaco del estudio;
    16. antecedentes o presencia de insuficiencia cardiaca congestiva (con FEVI < 45%) o hipertensión no controlada (con PA > 160/95 mmHg);
    17. uso de un marcapasos, desfibrilador implantable o endoprótesis metálica colocada internamente;
    18. frecuencia de pulso en reposo inferior a 68 latidos por minuto o defecto de conducción de alto grado en el electrocardiograma;
    19. una presión arterial sistólica en decúbito supino, en reposo, inferior a 100 mmHg;
    20. antecedentes de broncoespasmo y asma bronquial;
    21. antecedentes o diagnóstico de metástasis encefálicas
    E.5 End points
    E.5.1Primary end point(s)
    No primary end point
    Sin variable principal
    E.5.1.1Timepoint(s) of evaluation of this end point
    Not Applicable
    No aplicable
    E.5.2Secondary end point(s)
    Not Applicable
    No aplicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not Applicable
    No aplicable
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    India
    Malaysia
    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
    Last visit of last subject
    Ultima visita del último sujeto
    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 months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    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.1.1Number of subjects for this age range: 0
    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: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 56
    F.4.2.2In the whole clinical trial 129
    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)
    No plans for treatment after conclusion of the study
    No hay planes de tratamiento después de la finalización del ensayo
    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 Decision2012-10-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-27
    P. End of Trial
    P.End of Trial StatusOngoing
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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