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    Summary
    EudraCT Number:2013-004842-40
    Sponsor's Protocol Code Number:IG1309
    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:2014-03-07
    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 number2013-004842-40
    A.3Full title of the trial
    Pilot study to evaluate the effect of plasma exchange in motor and cognitive function in patients with amyotrophic lateral sclerosis
    Estudio piloto sobre los efectos del recambio plasmático en la disfunción motora y la función cognitiva en pacientes con esclerosis lateral amiotrófica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pilot study to evaluate the effect of plasma exchange with albumin in patients with amyotrophic lateral sclerosis
    Estudio piloto sobre los efectos del recambio plasmático con albúmina en pacientes con esclerosis lateral amiotrófica
    A.3.2Name or abbreviated title of the trial where available
    Albumin in ALS
    Albúmina en ELA
    A.4.1Sponsor's protocol code numberIG1309
    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 SponsorInstituto Grifols 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 supportInstituto Grifols S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstituto Grifols S.A.
    B.5.2Functional name of contact pointMiquel Barceló
    B.5.3 Address:
    B.5.3.1Street AddressAv. de la Generalitar 152-158
    B.5.3.2Town/ citySant Cugat del Vallés
    B.5.3.3Post code08174
    B.5.3.4CountrySpain
    B.5.4Telephone number34935712368
    B.5.5Fax number34935710381
    B.5.6E-mailmiquel.barcelo@grifols.com
    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 Albutein 5%
    D.2.1.1.2Name of the Marketing Authorisation holderInstituto Grifols S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNalbúmina humana
    D.3.9.3Other descriptive nameHUMAN ALBUMIN SOLUTION
    D.3.9.4EV Substance CodeSUB12026MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Amytrophic Lateral Sclerosis (ALS)
    Esclerosis Lateral Amiotrófica (ELA)
    E.1.1.1Medical condition in easily understood language
    Amytrophic Lateral Sclerosis (ALS)
    Synonyms: Motor Neuron Disease (most used term in UK) or Lou Gehrig's disease (most used tern in USA)
    Esclerosis Lateral Amiotrófica (ELA)
    Sinónimos: Enfermedad de la Motoneurona (término más usado en Reino Unido) o Enfermedad de Lou Gehrig (término más usado en Estados Unidos)
    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 16.1
    E.1.2Level PT
    E.1.2Classification code 10002026
    E.1.2Term Amyotrophic lateral sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the progress of the disease through functional scale (ALSFRS-R) and forced vital capacity (FVC) of patients with ALS treated with plasma exchange.
    Evaluar la evolución de la enfermedad a través de la escala funcional (ALSFRS-R) y de la capacidad vital forzada (FVC) de pacientes afectados de ELA tratados con recambio plasmático.
    E.2.2Secondary objectives of the trial
    Evaluate the effect of plasma exchange in ALS-related:
    - Cognitive dysfunction
    - Systemic inflammatory response
    - Oxidative Stress
    - Non-directed metabolome profile
    - Safety and tolerability
    Objetivos secundarios:
    Evaluar los efectos del recambio plasmático en pacientes con ELA sobre:
    - La disfunción cognitiva.
    - La respuesta inflamatoria sistémica.
    - El daño oxidativo.
    - El perfil del metaboloma no dirigido.
    - La seguridad y tolerabilidad del procedimiento
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be eligible for participation in the trial, the patients must meet the following requirements:
    - Must give written informed consent.
    - Age ?18 and <70 years.
    - Subjects with diagnosis of definitive, posible and probable ALS according El Escorial-Arlie criteria.
    - Subjects with ALS symptom onset < 18 months from recruitment.
    - FVC > 70%.
    - Be medically able to undergo study procedures and to comply with the visits schedule at the time of inclusion in the study.
    Para ser seleccionado para la participación en el ensayo, los pacientes deben cumplir con los siguientes requisitos:
    - Consentimiento informado firmado.
    - Edad superior a 18 años e inferior a 70 años.
    - Estar diagnosticado de ELA de carácter definido, posible, probable según criterios El Escorial-Arlie.
    - El inicio de los primeros síntomas de ELA se ha producido en un tiempo inferior a 18 meses respecto el momento del reclutamiento.
    - FVC > 70%.
    - Ser médicamente capaz de someterse a los procedimientos del estudio y de cumplir el calendario de visitas en el momento de la inclusión en el estudio.
    E.4Principal exclusion criteria
    Patients meeting any of the following criteria will not be able to participate in the trial:
    - Subjects with a clinically significant preexisting lung disease not attributable to ALS.
    - Subjects with a diagnosis of other neurodegenerative diseases or diseases associated with dysfunction of the motor neurons that can confuse the diagnosis of ALS.
    - Participation in other clinical trials, or the reception of any other investigational drug in the six months prior to the start of the study.
    - Female subjects who are pregnant, currently breastfeeding, or attempting to conceive during the study.
    - Difficult peripheral venous access precluding plasma exchange and inability to implement a viable alternative catheter to make continued performing plasma exchange visits according to protocol
    - Any contraindication for plasma exchange or abnormal coagulation parameters according clinical criteria from apheresis team (Banc de Sang i Teixits, BST Bellvitge).
    - A history of frequent adverse reactions (serious or otherwise) to blood products.
    - Hypersensitivity to albumin or allergies to any of the components of Albutein®.
    - Subjects that can not interrupt treatment with acetylsalicylic acid or oral anticoaguants
    - Plasma creatinine > 2mg/dl.
    - Present a history of heart disease including ischemic heart disease or congestive heart failure.
    - Presence of prior conduct disorders requiring pharmacologic intervention, with less than 3 months of stable treatment
    - Any condition that complicates adherence to study protocol (illness with less than one year of expected survival , drug or alcohol abuse, etc.)
    Pacientes que cumplan cualquiera de los siguientes criterios quedarán excluidos de participar en el ensayo:
    - Sujetos con una enfermedad pulmonar preexistente clínicamente significativa no atribuible a la ELA.
    - Sujetos con un diagnóstico de otras enfermedades neurodegenerativas o enfermedades asociadas a una disfunción de las neuronas motoras que puede confundir el diagnóstico de ELA.
    - Sujetos que participan o han participado hace menos de 6 meses en un ensayo clínico.
    - Mujeres embarazadas, lactantes o que tengan intención de concebir durante el período del estudio.
    - Acceso venoso periférico dificultoso o problemático e imposibilidad de implantar un catéter alternativo que haga inviable la realización continuada del recambio plasmático conforme al protocolo de visitas
    - Contraindicación para someterse a un recambio plasmático o parámetros anormales de la coagulación según criterio del equipo de aféresis (Banc de Sang i Texits, BST Bellvitge).
    - Historial de reacciones adversas graves o no graves pero frecuentes a productos derivados de la sangre.
    - Hipersensibilidad a la albúmina u otras alergias conocidas a cualquier componente de Albutein® 5%.
    - Sujetos que no puedan interrumpir el tratamiento con Ácido Acetilsalicílico o otra medicación antiagregante y anticoagulantes orales.
    - Presentar una concentración de creatinina >2 mg/dl.
    - Presentar enfermedad cardíaca que contraindique el tratamiento con recambio plasmático incluyendo historia de cardiopatía isquémica o insuficiencia cardíaca congestiva
    - Trastornos de conducta previos que requieran intervención farmacológica, con menos de 3 meses de tratamiento estable.
    - Cualquier condición que complica la adherencia al protocolo de estudio (enfermedad con menos de un año de supervivencia esperada, abuso de drogas o de alcohol, etc).
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in the functional scale ALSFRS-R (ALS functional rating scale-revised)
    Change from baseline in Forced Vital Capacity (FVC)
    Cambio respecto el basal en la escala funcional ALSFRS-R
    Cambio respecto el basal en la capacidad vital forzada (FVC)
    E.5.1.1Timepoint(s) of evaluation of this end point
    ALSFRS-R (6 measurements: week 0, 4, 12, 25, 36 y 48).
    FVC (6 measurements: week 0, 4, 12, 25 36 y 48).
    ALSFRS-R (6 mediciones: semana 0, 4, 12, 25, 36 y 48).
    FVC (6 mediciones: semana 0, 4, 12, 25 36 y 48).
    E.5.2Secondary end point(s)
    Secondary endpoints :
    - Changes from baseline in cognitive function as determined by clinical judgment, ALS -CBS test and Neary criteria for Frontotemporal Dementia (FTD)
    - Assessment electromyography muscle strength through evoked motor potential from tena, hypothenar and anterior tibial muscles
    - Assessment of quality of life through ALSA Q40 test.
    - Change in non-directed metabolome profile in cerebrospinal fluid (CSF ) and in plasma
    - Changes in plasma of albumin functional capacity
    - Changes in plasma of oxidative stress parameters
    - Changes in plasma of inflammatory mediators
    - Variations in CSF of oxidative stress parameters and inflammatory mediators

    Safety Variables :
    - The primary criterion of safety will be the percentage of plasma exchanges associated with at least one adverse event that may be related to the study procedure (adverse reactions) within 72h after the infusion completion.
    - In addition, the percentage of plasma exchanges involving some adverse event whether or not related to the procedure, will be considered in general
    - Vital signs will be recorded before, during and after each plasma exchange session, where required. Various laboratory test parameters (blood cell counts, platelet count, prothrombin time (Quick), aPTT, fibrinogen, total proteins, and calcium) will be also assessed when necessary.
    - According to the criterion of the investigator, all clinically relevant changes in vital function, laboratory test parameters will be evaluated.
    Variables secundarias:
    - Cambios respecto el basal en la función cognitiva determinado por criterio clínico, el test ALS-CBS y los criterios de Neary para la Demencia Frontotemporal (DFT)
    - Valoración de la fuerza muscular por electromiografía a través del potencial motor evocado en musculatura tena, hipotenar y tibial anterior
    - Valoración de calidad de vida a través del test ALSA Q40.
    - Variación en el perfil del metaboloma no dirigido en líquido cefalorraquídeo (LCR) y en plasma
    - Variaciones en plasma de la capacidad funcional de la albúmina
    - Variaciones en plasma parámetros de estrés oxidativo
    - Variaciones en plasma de mediadores de inflamación
    - Variaciones en LCR de parámetros de estrés oxidativo y mediadores de inflamación

    Variables de Seguridad:
    - Se considerará como principal criterio de seguridad el porcentaje de recambios plasmáticos que estén asociados como mínimo a un acontecimiento adverso que pueda estar relacionado con el procedimiento de estudio (reacciones adversas) dentro de 72h después de completar la infusión del producto.
    - Además, también se considerará globalmente el porcentaje de recambios plasmáticos con algún acontecimiento adverso, tengan o no relación con el procedimiento.
    - Los signos vitales se registrarán antes, durante y después de cada sesión de recambio plasmático, cuando se requiera. Varios parámetros de laboratorio (recuento de células sanguíneas, plaquetas, tiempo de protrombina (TP), tiempo parcial de tromboplastina activada prolongado (aPTT), fibrinógeno, proteínas totales y calcio) también serán evaluados cuando sea necesario.
    - De acuerdo con el criterio del investigador, los cambios clínicamente relevantes en la función vital, se evaluarán los parámetros de laboratorio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - ALS -CBS test and Neary criteria (3 measurements week 0, 25 and 36)
    - Electromyography muscle strength (6 measurements week 0, 4, 12, 25, 36 and 48).
    - ALSA Q40 test (3 measurements week 0, 25 and 48)
    - Non-directed metabolome profile in CSF and in plasma (3 measurements week 0, 12 and 25)
    - Albumin functional capacity (6 measurements week 0, 4, 12, 25, 36 and 48)
    - Oxidative stress parameters and inflammatory mediators in plasma (6 measurements week 0, 4, 12, 25, 36 and 48)
    - Oxidative stress parameters and inflammatory mediators in CSF (3 measurements week 0, 12 and 25)
    - ALS-CBS y los criterios de Neary (3 mediciones: semana 0, 25 y 48).
    - Fuerza muscular por electromiografía (6 mediciones: semana 0, 4, 12, 25, 36 y 48).
    - Calidad de vida a través del test ALSA Q40. (3 mediciones: semana 0, 25 y 48).
    - Perfil del metaboloma no dirigido en LCR y en plasma (3 mediciones: semana 0, 12 y 25).
    - Capacidad funcional de la albúmina en plasma (6 mediciones: semana 0, 4, 12, 25 36 y 48)
    - Estrés Oxidativo y mediadores de inflamación en plasma (6 mediciones: semana 0, 4, 12, 25 36 y 48)
    - Estrés oxidativo y mediadores de inflamación en LCR (3 mediciones: semana 0, 12 y 25).
    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 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.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 last patient
    Última visita último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 10
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Amyotrophic lateral sclerosis patients
    Pacientes con Esclerosis Lateral Amiotrófica
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    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
    Ninguno
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-05-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-02-06
    P. End of Trial
    P.End of Trial StatusCompleted
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