Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44238   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2007-002117-39
    Sponsor's Protocol Code Number:MEDALS
    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:2008-02-12
    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 number2007-002117-39
    A.3Full title of the trial
    MEMANTINA (Ebixa X) PARA LA DISCAPACIDAD FUNCIONAL EN LA ESCLEROSIS LATERAL AMIOTRÓFICA
    MEMANTINE (Ebixa R) FOR FUNCTIONAL DISABILITY IN AMYOTROPHIC LATERAL SCLEROSIS .
    A.3.2Name or abbreviated title of the trial where available
    MEDALS
    A.4.1Sponsor's protocol code numberMEDALS
    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 SponsorJorge Matias-Guiu Guia
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 Yes
    D.2.1.1.1Trade name EBIXA
    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 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 INNMEMANTINE HYDROCHLORIDE
    D.3.9.1CAS number 41100-52-1
    D.3.9.2Current sponsor codeEU/1/02/219/007-9
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number99%
    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 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
    Esclerosis Lateral Amiotrofica
    Amyotrophic lateral Sclerosis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    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
    Evaluar la eficacia de la memantina en la progresión de la discapacidad en la esclerosis lateral amiotrófica
    To asess the efficacy of memantine in the progression of discapacity in amyotrophic lateral sclerosis
    E.2.2Secondary objectives of the trial
    Evaluar la seguridad de la memantina en los pacientes con Esclerosis Lateral Amiotrófica
    To evaluate the safety of Memantine in patients with Amyotrophic Lateral Sclerosis
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Hombre /mujer adulto (rango 18-75 años de edad);
    2. Paciente con diagnóstico probable o definitivo de Esclerosis Lateral Amiotrófica (Brooks BR, Miller RG, Swash M, Munsat TL; World Federation of Neurology Research Group on Motor Neuron Diseases. El Escorial revisited: revised criteria for the diagnosis of amyotrophic lateral sclerosis. Amyotroph Lateral Scler Other Motor Neuron Disord. 2000 Dec; 1(5):293-9)
    3. Paciente con una evolución de la enfermedad inferior a 36 meses (rango 0 a 36)
    4. Escala de Puntuación Funcional de 20 a 35 puntos (rango: 0-40)
    5. El paciente deberá haber sido tratado con medicación para la ELA (riluzol) durante al menos 1 mes antes del estudio
    6. Riluzol será el único fármaco permitido en combinación

    • . Male/female adults (range 18-75 years old);

    2. Subjects with diagnosis of probable or definite Amyotrophic Lateral Sclerosis (Brooks BR, Miller RG, Swash M, Munsat TL; World Federation of Neurology Research Group on Motor Neuron Diseases. El Escorial revisited: revised criteria for the diagnosis of amyotrophic lateral sclerosis. Amyotroph Lateral Scler Other Motor Neuron Disord. 2000 Dec; 1(5):293-9)

    3. Subjects with a disease evolution of less than 36 months (range 0 to 36);

    4. Functional Rating Scale between 20 and 35 points (range: 0-40)

    5. Patients will have to be on ALS medication (riluzole) for at least 1 month before the study.

    6. Riluzole will be the only drug allowed in combination
    E.4Principal exclusion criteria
    1. Signos de bloqueo de la conducción de nervios motores, nervios sensoriales o ambos, en la electromiografía;
    2. Otra enfermedad neurológica;
    3. Signos de demencia (Estado Mini Mental inferior a 27);
    4. Paraproteinemia en la inmunoelectroforesis; disfunción tiroidea,diabetes;
    5. Para mejorar la detección de las variables de valoración, se excluirá al paciente si han transcurrido más de 36 meses desde el inicio de los primeros síntomas, si presenta otras enfermedades incapacitantes o de riesgo vital, si presenta una capacidad vital forzada del 60 por ciento o menos del valor esperado, si ha sido sometido a traqueotomía o si presenta una disfunción hepática o renal severa;
    6. Embarazo
    7. Incapacidad para otorgar el consentimiento informado escrito (con la asistencia del cónyuge si es necesario


    Signs of conduction blocks of motor nerves, sensory nerves, or both on electromyography;
    2. Other neurological disease;
    3. Signs of dementia (Mini Mental State less than 27);
    4. Paraproteinemia on immunoelectrophoresis; Thyroid malfunction,
    Diabetes
    5. To improve the detection of outcomes, patients will be excluded if more than 36 months had elapsed since the onset of their first symptoms, if they have other incapacitating or life-threatening diseases, if they have a forced vital capacity of 60 percent of the expected value or less, if they have undergone tracheotomy, or if they have severe hepatic or renal dysfunction;
    6. Pregnancy;
    E.5 End points
    E.5.1Primary end point(s)
    Incapacidad Funcional
    El investigador del estudio (investigador enmascarado) evaluará el estado funcional del paciente en todas las visitas de seguimiento (selección, basal, 1, 3, 6, 9 y 12 meses) a través de la Escala de Puntuación Funcional de 40 puntos que tiene una elevada fiabilidad inter-calificadores. Se trata de una calificación de cuatro ítems que incluye puntuaciones de la función de las extremidades, función bulbar, resultados de la exploración física y síntomas comunicados por el paciente.

    Functional Disability.

    Functional status will be assessed by a study investigator (blinded investigator) at all follow-up visits (screening, baseline, 1, 3, 6, 9 and 12 months) with the use of the 40-point Functional Rating Scale that has a high interrater reliability. This is a four-point rating that includes scores for limb function, bulbar function, the results of clinical examination, and symptoms reported by the patient.
    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.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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    add on with riluzole in both sides
    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 EEA2
    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 Information not present in EudraCT
    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
    Dos años desde el inicio
    Two years from the begginning
    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
    E.8.9.2In all countries concerned by the trial years2
    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 Information not present in EudraCT
    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
    In Amyotrophic Lateral Sclerosis patients can not be able to phisically sign the consent but yes give his consent and this be sign by other person
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    disease with no cure
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 140
    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 Decision2008-01-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-17
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    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.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA