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    Summary
    EudraCT Number:2009-013097-40
    Sponsor's Protocol Code Number:NP031112-08B02
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-07-29
    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 number2009-013097-40
    A.3Full title of the trial
    Estudio doble-ciego, controlado con placebo, aleatorizado, de grupos paralelos, para evaluar la seguridad, tolerancia y eficacia de dos dosis orales diferentes de NP031112, un inhibidor de GSK3, versus placebo, como tratamiento de pacientes con Parálisis Supranuclear Progresiva leve o moderada
    A.4.1Sponsor's protocol code numberNP031112-08B02
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNoscira S.A.
    B.1.3.4CountrySpain
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameNP031112
    D.3.2Product code NP031112 600mg
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 865854-05-3
    D.3.9.2Current sponsor codeNP031112
    D.3.9.3Other descriptive name4-benzyl-2-naphtalen-1-yl-1,2,4-thiadiazolidine-3,5-dione
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameNP031112
    D.3.2Product code NP031112 800mg
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 865854-05-3
    D.3.9.2Current sponsor codeNP031112
    D.3.9.3Other descriptive name4-benzyl-2-naphtalen-1-yl-1,2,4-thiadiazolidine-3,5-dione
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number800
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    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
    Parálisis Supranuclear Progresiva leve o moderada
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9
    E.1.2Level LLT
    E.1.2Classification code 10036813
    E.1.2Term Progressive supranuclear palsy
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9
    E.1.2Level PT
    E.1.2Classification code 10036813
    E.1.2Term Progressive supranuclear palsy
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar el cambio clínico global mediante la Escala de Parálisis Supranuclear Progresiva de Golbe tras 52 semanas de tratamiento con 2 dosis diferentes de NP031112 vs. placebo en pacientes con posible o probable Parálisis Supranuclear Progresiva (PSP) leve o moderada.
    E.2.2Secondary objectives of the trial
    Evaluar la seguridad y tolerancia de 2 dosis diferentes de NP031112 administrado durante 52 semanas en pacientes con posible o probable PSP leve o moderada.
    Evaluar los cambios clínicos funcionales tras 52 semanas de tratamiento con 2 dosis diferentes de NP031112 vs. placebo en:
    o función motora
    o función cognitiva
    o conducta
    o actividades de la vida diaria (ADL)
    o calidad de vida
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Hombres y mujeres con diagnóstico de posible o probable PSP leve o moderada según los criterios clínicos del National Institute of Neurologic Diseases and Stroke – the Society for PSP.
    2. Edad de 40 a 85 años (los pacientes mayores de 85 años podrán ser incluidos tras una evaluación previa por el Investigador y la aprobación del promotor).
    3. Estudio de RNM cerebral en los últimos 12 meses antes de la visita basal, que excluya otras causas potenciales de parkinsonismo, especialmente lesiones cerebrovasculares, y lesiones ocupantes de espacio.
    4. Estadio de gravedad de la enfermedad 1 a 3 según el Sistema de Estadiaje de Golbe.
    5. Ausencia de posibilidad de embarazo: por esterilización quirúrgica, o 1 año como mínimo de postmenopausia (confirmado con test de hormona folículo-estimulante [FSH] > 20 unidades internacionales [UI]) o control adecuado de embarazo (anticonceptivo hormonal, dispositivo intrauterino, método de doble barrera [condón con espermicida, diafragma con espermicida, o condón y diafragma]), o abstinencia sexual durante el estudio. Los pacientes varones deben estar dispuestos a usar anticoncepción de barrera (condón) durante el estudio y hasta 6 meses tras la administración del último tratamiento.
    6. Un cuidador (o enfermera asignada) que viva en la misma casa o que conviva con el paciente durante >4 horas al día capaz de asegurar la preparación y administración correcta de la medicación del estudio.
    7. Pacientes que vivan en su casa o en una residencia pero que no requieran cuidados continuos de enfermería.
    8. Estado de salud general aceptable para participar en un ensayo clínico de 64 semanas.
    9. Capacidad de ingerir 100 mL de suspensión acuosa.
    10. Cualquier medicación concomitante para la PSP debe ser bien tolerada y estable durante al menos 1 mes antes de la visita basal y su dosis y régimen deben mantenerse durante el estudio salvo que existan razones clínicas para su modificación.
    11. La terapia ocupacional, física, respiratoria, o del lenguaje está permitida pero deber ser estable durante al menos 1 mes antes del cribado.
    12. El tratamiento farmacológico de cualquier otra patología crónica debe ser estable y bien tolerado durante al menos 1 mes antes del cribado. Los analgésicos, anti-inflamatorios no esteroideos ocasionales a demanda, y los tratamientos de cuadros clínicos transitorios o emergentes están permitidos.
    13. Firma por parte del paciente o de su representante legal del Consentimiento Informado (CI) antes del inicio de cualquier procedimiento específico del estudio.
    E.4Principal exclusion criteria
    1. Incapacidad para realizar los exámenes de cribado o basales.
    2. Hospitalización o cambio en la medicación habitual concomitante durante el mes previo al periodo de cribado (excepto una hospitalización previamente programada por alguna afección que no haya empeorado durante el mes previo al periodo de cribado).
    3. Datos clínicos, de laboratorio o neuroimagen consistentes con:
    • otras enfermedades degenerativas primarias como enfermedad de Parkinson; demencia con cuerpos de Lewy, degeneración corticobasal; demencia frontotemporal; atrofia multisistémica; complejo parkinsonismo-demencia de Guam; Kii o Guadalupe; enfermedad de Alzheimer; esclerosis lateral amiotrófica; enfermedad de Creutzfeld-Jakob; enfermedad de Huntington; síndrome de Down, etc.
    • enfermedad cerebrovascular: infarto grueso, estratégico o multilacunar, o lesiones extensas de sustancia blanca con puntuación 3 en la escala de Wahlund.
    • otras enfermedades del sistema nervioso central (hidrocefalia, traumatismo craneal grave, tumores, hematoma subdural u otros procesos relevantes ocupantes de espacio, etc.).
    • epilepsia.
    • otras enfermedades infecciosas, metabólicas o sistémicas que afecten al sistema nervioso central (sífilis, hipotiroidismo activo, deficiencia de vitamina B12 o folato, trastornos hidroelectrolíticos clínicamente significativos, diabetes mellitus de comienzo juvenil, etc.).
    4. Diagnóstico actual de depresión mayor activa, esquizofrenia o trastorno bipolar según el Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV).
    5. Enfermedad clínicamente significativa, avanzada o inestable que pueda interferir con las evaluaciones de la variables primarias o secundarias, distorsionar el examen clínico o mental o plantear un riesgo especial para el paciente, como:
    • enfermedad hepática crónica, anomalías en los test de función hepática u otros signos de insuficiencia hepática
    • insuficiencia respiratoria
    • insuficiencia renal (creatinina sérica >2 mg/dL (>150 &#61549;mol/L) y aclaramiento de creatinina <60 según la formula de Cockcroft-Gault)
    • enfermedad cardiaca (infarto de miocardio, angina inestable, insuficiencia cardiaca, cardiomiopatía en los 6 meses previos al cribado).
    • bradicardia (<50 latidos/min) o taquicardia (>95 latidos/min)
    • episodios de hipertensión inestable o descontrolada (presión sistólica >160 mmHg o diastólica >100 mmHg) o hipotensión (presión sistólica <90 mmHg o diastólica <45 mmHg) durante los 2 meses antes del examen basal.
    • bloqueo atrioventricular (tipo II / Mobitz II y tipo III), síndrome congénito de QT prolongado, disfunción del nodo sinusal o intervalo QTcF prolongado (varones >450 mseg y mujeres >470 mseg usando la formula de Fridericia: QTc = QT / raíz cúbica de RR).
    • diabetes mellitus no controlada.
    • tumores malignos en los últimos 5 años excepto cutáneos (salvo el melanoma) o cáncer de próstata indolente.
    • metástasis.
    6. Discapacidad que pueda impedir al paciente completar todos los requerimientos del estudio (eg, ceguera, sordera o trastornos del lenguaje graves).
    7. Ingesta diaria crónica de alguno de estos fármacos:
    • fármacos metabolizados por el citocromo P450 (CYP) 3A4 con ventana terapéutica estrecha (acenocumarol, warfarina, digitoxina)
    • antiepilépticos
    • anticolinérgicos
    • inhibidores de la acetilcolinesterasa
    • tricíclicos
    • neurolépticos excepto quetiapina, clozapina u otros neurolépticos atípicos
    • nootrópicos como piracetam, propentofilina, hidergina, vinpocetina, ginkgo biloba, coenzima Q-10, idebenona o derivados
    • fármacos anti-hipertensivos de acción central (clonidina, &#61537;-metil dopa, guanidina, guanfacina)
    • corticoesteroides sistémicos o inmunosupresores
    • antiinflamatorios no esteroideos sistémicos (excepto como tratamiento ocasional a demanda, o ácido acetilsalicílico hasta 100 mg/día como antiagregante).
    • memantina, litio, ácido valproico u otros inhibidores de GSK-3 durante 3 meses antes de la visita basal
    8. Sospecha o historia franca de abuso de drogas o alcohol.
    9. Sospecha o historia franca de alergia a cualquier componente de la medicación del estudio.
    10. Participación en otro estudio de investigación en los 3 meses antes de la visita basal.
    11. Cualquier circunstancia que, en opinión del Investigador, haga al paciente no idóneo para la inclusión o con posibilidad de no ser colaborador.
    E.5 End points
    E.5.1Primary end point(s)
    Criterio Primario de Evaluación de la Eficacia:
    Cambio con respecto a la visita basal de los 2 grupos tratados con el medicamento activo comparado con el grupo placebo en la escala de Parálisis Supranuclear Progresiva de Golbe
    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 Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 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.8.3 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 EEA17
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    Ultima Paciente ultima visita
    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 days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Algunos pacientes de PSP tendrán una función cognitiva comprometida que llegue a la clasificación de demencia por lo que se requerirá que un representante legal dé el consentimiento.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 125
    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)
    Tratamiento habitual
    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 Decision2009-11-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-11-06
    P. End of Trial
    P.End of Trial StatusCompleted
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