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    The EU Clinical Trials Register currently displays   44237   clinical trials with a EudraCT protocol, of which   7338   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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    Summary
    EudraCT Number:2010-022818-19
    Sponsor's Protocol Code Number:223AS302
    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:2011-02-21
    Trial results View 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 number2010-022818-19
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, multi-center study of the safety and efficacy of Dexpramipexole in subjects with amyotrophic lateral sclerosis.
    Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo, de la seguridad y eficacia de Dexpramipexol en sujetos con Esclerosis Lateral Amiotrófica
    A.3.2Name or abbreviated title of the trial where available
    EMPOWER
    A.4.1Sponsor's protocol code number223AS302
    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 SponsorBiogen Idec 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 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 Yes
    D.2.5.1Orphan drug designation numberEU/3/09/616
    D.3 Description of the IMP
    D.3.1Product nameDexpramipexole
    D.3.2Product code BIIB050 / KNS-760704
    D.3.4Pharmaceutical form Film-coated tablet
    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.3.8INN - Proposed INN(6R)-4, 5, 6, 7 - tetrahydro-N6-propyl-2,6-benzothiazolidiamine dihydrochloride monohydrate
    D.3.9.1CAS number 908244-04-2
    D.3.9.2Current sponsor codeBIIB050 / KNS-760704
    D.3.9.3Other descriptive nameDexpramipexole
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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
    Amyotrophic lateral sclerosis (ALS)
    Esclerosis lateral amiotrófica (ELA)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10002026
    E.1.2Term Amyotrophic lateral sclerosis
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo principal del estudio es evaluar la eficacia de la administración oral de 150 mg de dexpramipexol dos veces al día en comparación con el placebo durante 12 meses en sujetos con ELA.
    E.2.2Secondary objectives of the trial
    Los objetivos secundarios del estudio son evaluar la seguridad y los perfiles farmacocinéticos (FC) de la administración oral de 150 mg de dexpramipexol dos veces al día.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Capacidad de comprender el objetivo y los riesgos del estudio y de dar el consentimiento informado firmado y fechado y la autorización para el uso de información sanitaria protegida (ISP) de acuerdo con los reglamentos nacionales y locales sobre la privacidad de los sujetos.2. El sujeto tiene entre 18 y 80 años de edad (ambas inclusive) el día 1.3. Al sujeto se le ha diagnosticado ELA esporádica o familiar.4. El inicio de los primeros síntomas de ELA del sujeto tuvo lugar < o = 24 meses antes del día 1. 5. El sujeto cumple los criterios de El Escorial de diagnóstico de ELA posible, probable respaldado por los resultados analíticos, probable o demostrada de acuerdo con la Federación Mundial de Neurología (revisados de acuerdo con el Congreso de Airlie House de 1998). Los sujetos que cumplan la definición de ELA posible deben presentar signos o síntomas de la neurona motora superior (NMS) y de la neurona motora inferior (NMI) en al menos una región.6. El sujeto tiene una CVL (de pie) > o = 65% al valor previsto para la edad, la altura y el sexo en la selección.7. El sujeto no ha tomado riluzol durante un mínimo de 30 días antes del día 1 o lleva recibiendo una dosis estable de riluzol desde al menos 60 días antes del día 1. (Los sujetos que no han recibido nunca riluzol pueden participar en el estudio.8. El sujeto es médicamente capaz de someterse a los procedimientos del estudio y de cumplir con el calendario de visitas en el momento de su inclusión en el estudio.9. El sujeto es capaz de tomar un tratamiento oral sin machacar o romper los comprimidos en el momento de su inclusión en el estudio según la evaluación del investigador del centro.10. Los sujetos en edad fértil deben tomar medidas anticonceptivas eficaces durante el estudio y estar dispuestos a seguir con ellas durante un mes (mujeres) o tres meses (varones) después de su última dosis del tratamiento del estudio
    E.4Principal exclusion criteria
    1.Sujetos en los cuales no se han excluido causas de debilidad neuromuscular distintas de la ELA.2. Sujetos con alteración cognitiva significativa, demencia clínica o enfermedad psiquiátrica.3. Sujetos con un diagnóstico de otras enfermedades neurodegenerativas (por ejemplo, enfermedad de Parkinson, enfermedad de Alzheimer, etc..).4. Sujetos con antecedentes clínicamente significativos de enfermedad cardíaca inestable o grave, enfermedad oncológica, hepática o renal u otras patologías médicamente importantes.5. Sujetos con una enfermedad pulmonar preexistente clínicamente significativa no atribuida a la ELA.6. Sujetos con antecedentes de alergia grave a fármacos o enfermedad alérgica grave (choque anafiláctico).7. Sujetos con anomalías clínicamente significativas en el ECG en la visita de selección (por ejemplo, QTc > 500 ms (donde el QTc es el intervalo situado entre el inicio del complejo QRS y el final de la onda T, corregido para la frecuencia cardíaca) o elevaciones agudas del segmento ST).8. Sujetos con anomalías clínicamente significativas en los valores analíticos clínicos, según determine el investigador en la visita de selección.9. Sujetos con una cifra absoluta de neutrófilos (CAN) < 1,96 x 1000/µl en la visita de selección o antecedentes documentados de neutrocitopenia.10. Sujetos con un valor de la aspartato aminotransferasa (AST) o la alanina aminotransferasa (ALT) > 3,0 veces el límite superior de lo normal en la visita de selección.11. Sujetos con aclaramiento de la creatinina (AclCr, calculado según la ecuación de la Modificación de la Alimentación en la Enfermedad Renal) < o = 50 ml/min en la visita de selección.12. Mujeres embarazadas o lactantes.13. Sujetos con antecedentes de abuso del alcohol o de sustancias en el año previo al día 1, según determine el investigador.14. Sujetos que probablemente incumplirán los requisitos del estudio.15. Sujetos que se han expuesto a cualquier otro fármaco experimental (uso extraoficial o investigacional) en los 30 días previos al día 1.16. Sujetos con exposición previa al dexpramipexol.
    17. Sujetos que tomen pramipexol u otros agonistas de la dopamina
    E.5 End points
    E.5.1Primary end point(s)
    Rango conjunto de los resultados funcionales ajustados por mortalidad. El análisis del rango conjunto se basa en el cambio respecto al inicio del estudio en la puntuación de la ALSFRS-R y el tiempo hasta la muerte utilizando los datos de un seguimiento de 12 meses
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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) 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.8.3 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    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 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
    El fin del estudio es la última 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 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 months10
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state31
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 370
    F.4.2.2In the whole clinical trial 804
    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)
    A los sujetos que completen el tratamiento del estudio según el protocolo (entre 12 y 18 meses, según su fecha de inclusión) se les dará la opción de participar en un estudio de extensión abierto .
    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 Decision2011-06-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-11-16
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