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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43396   clinical trials with a EudraCT protocol, of which   7179   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).

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    EudraCT Number:2020-003976-42
    Sponsor's Protocol Code Number:OT_101_001
    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:2022-02-25
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2020-003976-42
    A.3Full title of the trial
    A phase III, randomized, double-masked, placebo controlled,
    parallel-group, multicenter study of the safety and efficacy of OT-101 (Atropine 0.01%) in treating the progression of myopia in pediatric
    Estudio de fase III, aleatorizado, controlado con placebo, de grupos paralelos, con enmascaramiento doble y multicéntrico sobre la seguridad y eficacia de OT-101 (sulfato de atropina al 0,01 %) como tratamiento de la progresión de la miopía en sujetos pediátricos
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A large scale study to confirm and expand the information on the safety and effectiveness of atropine in treating the progression of myopia in pediatric subjects.
    Estudio a gran escala para confirmar y ampliar la información sobre la seguridad y eficacia de la atropina en el tratamiento de la progresión de la miopía en sujetos pediátricos.
    A.4.1Sponsor's protocol code numberOT_101_001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04770610
    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 SponsorOcumension (Hong Kong) Limited
    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 supportOcumension (Hong Kong) Limited
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOcumension (Hong Kong) Limited
    B.5.2Functional name of contact pointOT101 Clinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressRoom 502-1, Want Want Plaza, No. 211 Shimen Yi Road
    B.5.3.2Town/ cityJing’an District, Shanghai
    B.5.3.3Post code200041
    B.5.4Telephone number+8621-61493868
    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 nameAtropine sulfate
    D.3.2Product code OT_101_001
    D.3.4Pharmaceutical form Eye drops, powder and solvent for solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 55-48-1
    D.3.9.4EV Substance CodeSUB00625MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.01
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboEye drops, powder and solvent for suspension
    D.8.4Route of administration of the placeboOcular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    E.1.1.1Medical condition in easily understood language
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of OT- 101 Ophthalmic Solution in treating the progression of myopia in Pediatric subjects following 3 years treatment
    Evaluar la eficacia de la solución oftálmica OT-101 en el tratamiento de la progresión de la miopía en sujetos pediátricos después de 3 años de tratamiento
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of OT-101 Ophthalmic Solution in Pediatric subjects with myopia
    Evaluar la seguridad y tolerabilidad de la solución oftálmica OT-101 en sujetos pediátricos con miopía
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must:
    1. A parent or legal guardian of each subject must provide written informed consent and sign theHIPAA form (or equivalent, if applicable), approved by the appropriate Institutional Review Board (IRB)/Ethical Committee (EC). Whenever practical and appropriate per local requirements, a child’s assent should also be sought before inclusion into the study. The protocol is being conducted in various countries with varying ages for consent and is written to require informed consent procedures for minors in the EU based on national requirements, based on the latest guidelines on informed consent of minors. For subjects reaching age of consent during the study duration as per local requirements, consent must be obtained on the appropriate Participant Consent Form;
    2. Be able to comply with study requirements, attend all study visits, have ability to read and understand native language of subject, and be accompanied by a parent/legal guardian;
    3. Be between 3 - 15 years of age of either sex and any race or ethnicity at Visit 1 (Day -14 to -1);
    4. Have refractive error by cycloplegic autorefraction at baseline (Visit 1) in the study eye of:
    a. myopia between -1.00 D and -6.00 D, inclusive, of spherical equivalent
    b. astigmatism less than or equal to 1.50 DC
    5. Have anisometropia ≤ 1.0 D at Visit 1;
    6. Have a best-corrected distance visual acuity of (BCVA) of logarithm of the minimum angle of resolution (logMAR)
    ≤0.4 (approximately Snellen 20/50) for 3 year olds; logMAR ≤0.3 (approximately Snellen 20/40) for 4 year olds; logMAR ≤0.18 (approximately Snellen 20/30) for ≥5 year olds) in each eye as measured using an Early Treatment for Diabetic Retinopathy Study (ETDRS) chart [R,1 or 2], or Lea Chart for subjects who do not know the alphabet, at Visit 1 and Visit 2;
    7. Be able and willing to avoid all disallowed medications for the appropriate washout period between screening
    and randomization and during the study without significant risk to the subject.
    Los sujetos deben:
    1. Un padre o tutor legal de cada sujeto debe proporcionar un consentimiento informado por escrito y firmar el formulario de la HIPAA (o equivalente, si corresponde), aprobado por la Junta de Revisión Institucional (IRB) / Comité de Ética (CE) correspondiente. Siempre que sea práctico y apropiado según los requisitos locales, también se debe buscar el consentimiento de un niño antes de su inclusión en el estudio. El protocolo se está llevando a cabo en varios países con diferentes edades para el consentimiento y está escrito para requerir procedimientos de consentimiento informado para menores en la UE según los requisitos nacionales, según las últimas pautas sobre el consentimiento informado de menores. Para los sujetos que alcanzan la edad de consentimiento durante la duración del estudio según los requisitos locales, se debe obtener el consentimiento en el Formulario de consentimiento del participante correspondiente;
    2. Ser capaz de cumplir con los requisitos de estudio, asistir a todas las visitas de estudio, tener la capacidad de leer y comprender el idioma nativo del sujeto y estar acompañado por un padre / tutor legal;
    3. Tener entre 3 y 15 años de edad de cualquier sexo y cualquier raza o etnia en la Visita 1 (Día -14 a -1);
    4. Tener un error de refracción por autorrefracción ciclopléjica al inicio del estudio (Visita 1) en el ojo de estudio de:
    a)miopía entre -1,00 D y -6,00 D, inclusive, de equivalente esférico, b)astigmatismo menor o igual a 1,50 DC
    5. Tener anisometropía ≤ 1.0 D en la Visita 1;
    6. Tener una agudeza visual a distancia mejor corregida del logaritmo del ángulo mínimo de resolución (logMAR)
    ≤0,4 (aproximadamente Snellen 20/50) para niños de 3 años; logMAR ≤0,3 (aproximadamente Snellen 20/40) para niños de 4 años; logMAR ≤0.18 (aproximadamente Snellen 20/30) para niños ≥5 años) en cada ojo, medido con un gráfico del Estudio de tratamiento temprano para la retinopatía diabética (ETDRS) [R, 1 o 2], o un gráfico Lea para sujetos que no saben el alfabeto, en la Visita 1 y la Visita 2;
    7. Ser capaz y estar dispuesto a evitar todos los medicamentos no permitidos durante el período de lavado apropiado entre exámenes de selección y aleatorización y durante el estudio sin riesgo significativo para el sujeto.
    E.4Principal exclusion criteria
    Subjects must not:
    1. Have known contraindications or sensitivity to atropine, the study medications, or their components;
    2. Have clinically significant abnormal findings on slit lamp biomicroscopy exam (e.g., cataract) which may impact best corrected visual acuity measures in either eye at screening or a known history of a clinically significant slit lamps findings in either eye;
    3. Have clinically significant abnormal findings on indirect dilated fundoscopy exam in either eye at screening or a known history of a clinically significant retinal findings in either eye;
    4. Have any evidence of an eye movement disorder or restriction of extraocular movement (e.g.,nystagmus);
    5. Have an active ocular infection (i.e., bacterial, viral, or fungal);
    6. Have active or a history of chronic or recurrent episodes of ocular inflammation (e.g., moderate to severe blepharitis, allergic conjunctivitis, peripheral ulcerative keratitis, scleritis) in either eye;
    7. Have a history of ocular herpetic infection, iritis, scleritis, or uveitis, whether active or inactive at screening;
    8. Have undergone any myopia control treatment including atropine, orthokeratology, rigid gas-permeable contact lenses, bifocal contact lenses, progressive addition spectacle lenses, or other lenses to reduce myopia progression in the previous 6 months. Myopic correction in the form of single-vision eyeglasses and/or single-vision soft contact lenses are allowed;
    9. Have undergone any form of refractive eye surgery including incisional keratotomy, photorefractive keratectomy [PRK], laser in situ keratomileusis [LASIK], laser-assisted sub-epithelial keratectomy [LASEK]), corneal inlay procedures, conductive keratoplasty, small incision lenticule extraction (SMILE), cataract extraction, or any form of intraocular lens implantation;
    10. Have intraocular pressure (IOP) that is < 9 millimeters of mercury (mmHg) or > 21 mmHg in either eye, or have a prior diagnosis of ocular hypertension or glaucoma or currently being treated with any type of topical IOP lowering (glaucoma) medication;
    11. Have had surgical intervention (ocular or systemic) within 6 months prior to Visit 1, or planned surgical intervention during the study;
    12. Use any of the following disallowed medications or therapies by any route of administration during the 2 weeks (14 days) prior to Visit 2 (Day 1):
    a. any prescription or over the counter ophthalmic products (Use of preservative-free artificial tears is allowed but may not be used within 2 hours of administration of study medication. Use of lubricating ointment form of artificial tears before bedtime is allowed but must be used at least 15 minutes after administration of study medication.)
    b. monoamine oxidase inhibitors
    c. atropine, pirenzepine, or other anti-muscarinic agent
    d. any medication affecting the pupil or accommodation
    e. orthoK, rigid gas-permeable, bifocal, progressive-addition, multi-focal, or other lenses to reduce myopia progression. In addition, Groups b – e above are not allowed for the duration of the study.
    13. The anticipated need to use chronic ophthalmic or systemic oral corticosteroids during the study. Intranasal, inhaled, topical dermatologic, intra-articular, perianal steroids, and short-term oral steroids (< 2 weeks) are permitted;
    14. Participation in any other study of investigational therapy during the study period or within 30days before Visit 1;
    15. Female subjects who are pregnant, nursing, or plan to become pregnant at any time during the study;
    16. History or current evidence of a medical condition predisposing the patient to degenerative myopia (e.g., Marfan syndrome, Stickler syndrome) or a condition that may affect visual function or development (e.g., diabetes mellitus, chromosome anomaly)
    17. Have a central nervous system disorder (e.g., epilepsy, cerebral disorders, Down syndrome)
    18. Have a condition or a situation, which in the Investigator’s opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject’s study participation, including but not limited to unstable: cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease
    Los sujetos no deben:
    1. Tener contraindicaciones conocidas o sensibilidad a la atropina, los medicamentos del estudio o sus componentes;
    2. Tener hallazgos anormales clínicamente significativos en el examen de biomicroscopía con lámpara de hendidura (p. Ej., Cataratas) que puedan afectar las medidas de agudeza visual mejor corregidas en cualquiera de los ojos en el momento del cribado o antecedentes conocidos de hallazgos de lámparas de hendidura clínicamente significativos en cualquiera de los ojos;
    3. Tener hallazgos anormales clínicamente significativos en el examen de fundoscopia con dilatación indirecta en cualquiera de los ojos en el momento de la selección o antecedentes conocidos de hallazgos retinianos clínicamente significativos en cualquiera de los ojos;
    4. Tener alguna evidencia de un trastorno del movimiento ocular o restricción del movimiento extraocular (por ejemplo, nistagmo);
    5. Tener una infección ocular activa (es decir, bacteriana, viral o micótica);
    6. Tener un historial activo o de episodios crónicos o recurrentes de inflamación ocular (p. Ej., Blefaritis de moderada a grave, conjuntivitis alérgica, queratitis ulcerosa periférica, escleritis) en cualquiera de los ojos;
    7. Tener antecedentes de infección ocular herpética, iritis, escleritis o uveítis, ya sea activa o inactiva en la selección;
    8. Haber sido sometido a algún tratamiento de control de la miopía, incluyendo atropina, ortoqueratología, lentes de contacto rígidas permeables a los gases, lentes de contacto bifocales, lentes para gafas de adición progresiva u otras lentes para reducir la progresión de la miopía en los 6 meses anteriores. Se permite la corrección miopía en forma de anteojos monofocales y / o lentes de contacto blandas monofocales;
    9. Haberse sometido a cualquier tipo de cirugía ocular refractiva, incluida queratotomía incisional, queratectomía fotorrefractiva [PRK], queratomileusis in situ con láser [LASIK], queratectomía subepitelial asistida por láser [LASEK]), procedimientos de incrustación corneal, queratoplastia conductiva, lentículo de incisión pequeña extracción (SMILE), extracción de cataratas o cualquier forma de implantación de lentes intraoculares;
    10. Tener una presión intraocular (PIO) <9 milímetros de mercurio (mmHg) o> 21 mmHg en cualquiera de los ojos, o tener un diagnóstico previo de hipertensión ocular o glaucoma o estar siendo tratado actualmente con cualquier tipo de medicación tópica de reducción de la PIO (glaucoma);
    11.Haber tenido una intervención quirúrgica (ocular o sistémica) en los 6 meses anteriores a la Visita 1, o una intervención quirúrgica planificada durante el estudio;
    12.Usar cualquiera de los siguientes medicamentos o terapias no permitidos por cualquier vía de administración durante las 2 semanas (14 días) antes de la Visita 2 (Día 1):
    A)cualquier producto oftálmico recetado o de venta libre (se permite el uso de lágrimas artificiales sin conservantes, pero no se pueden usar dentro de las 2 horas posteriores a la administración del medicamento del estudio. Se permite el uso de ungüento lubricante en forma de lágrimas artificiales antes de acostarse, pero se debe usar al menos 15 minutos después de la administración de la medicación del estudio)
    B)inhibidores de la monoaminooxidasa
    C)atropina, pirenzepina u otro agente antimuscarínico
    D)cualquier medicamento que afecte a la pupila o la acomodación
    E)Lentes ortopédicas, rígidas, permeables a los gases, bifocales, de adición progresiva, multifocales u otras para reducir la progresión de la miopía. Además, los grupos b - e anteriores no están permitidos durante la duración del estudio.
    13. La necesidad anticipada de utilizar corticosteroides orales sistémicos o oftálmicos crónicos durante el estudio. Se permiten esteroides intranasales, inhalados, dermatológicos tópicos, intraarticulares, perianales y esteroides orales a corto plazo (<2 semanas);
    14. Participación en cualquier otro estudio de terapia en investigación durante el período de estudio o dentro de los 30 días anteriores a la Visita 1;
    15. Mujeres embarazadas, lactantes o que planean quedar embarazadas en cualquier momento durante el estudio;
    16. Historia o evidencia actual de una condición médica que predispone al paciente a la miopía degenerativa (por ejemplo, síndrome de Marfan, síndrome de Stickler) o una condición que pueda afectar la función o el desarrollo visual (por ejemplo, diabetes mellitus, anomalía cromosómica)
    17. Tener un trastorno del sistema nervioso central (p. Ej., Epilepsia, trastornos cerebrales, síndrome de Down)
    18. Tener una afección o situación que, en opinión del investigador, puede poner al sujeto en mayor riesgo, confundir los datos del estudio o interferir significativamente con la participación del sujeto en el estudio, incluidos, entre otros, inestables: cardiovasculares, hepáticos, renales, respiratorios. , gastrointestinal, endocrina, inmunológica, dermatológica, hematológica, neurológica o psiquiátrica
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of study eyes with a -0.75D of progressive myopia at Month 36 defined as an increase in spherical equivalent of -0.75D or greater as assessed by cycloplegic autorefraction.
    Porcentaje de ojos del estudio con un -0,75D de miopía progresiva en el mes 36 definido como un aumento en el equivalente esférico de -0,75D o mayor según lo evaluado por la autorrefracción ciclopléjica.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Month 36
    Mes 36
    E.5.2Secondary end point(s)
    Change from baseline to Month 36 in study eye spherical equivalent (D) as assessed by cycloplegic autorefraction. Change from baseline to Month 36 in study eye axial length as measured by cycloplegic biometry (a device will be selected and the same device to be used throughout the duration of this study)
    Cambio desde el inicio hasta el mes 36 en el equivalente esférico ocular del estudio (D) evaluado por autorrefracción ciclopléjica. Cambio desde el inicio hasta el mes 36 en la longitud axial del ojo del estudio según lo medido por biometría ciclopléjica (se seleccionará un dispositivo y se utilizará el mismo dispositivo durante la duración de este estudio)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Month 36
    Mes 36
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the 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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Última Visita Último Paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 678
    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) Yes
    F. of subjects for this age range: 339
    F.1.1.6Adolescents (12-17 years) Yes
    F. of subjects for this age range: 339
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 255
    F.4.2.2In the whole clinical trial 678
    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)
    patient will not be treateat after the-study period
    El paciente no será tratado después del período de estudio.
    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 Decision2022-02-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusOngoing
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