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    Summary
    EudraCT Number:2012-003315-63
    Sponsor's Protocol Code Number:ARPA-AMANTADINA-2012
    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:2012-08-23
    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 number2012-003315-63
    A.3Full title of the trial
    RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, STUDY OF EFFECTIVENESS, TOLERABILITY AND SAFETY OF THERAPY WITH AMANTADINE IN DEGENERATIVE ATAXIAS
    ESTUDIO ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO, DE EFICACIA, TOLERANCIA Y SEGURIDAD DEL TRATAMIENTO CON AMANTADINA EN LAS ATAXIAS DEGENERATIVAS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    STUDY OF EFFECTIVENESS, TOLERABILITY AND SAFETY OF THERAPY WITH AMANTADINE IN DEGENERATIVE ATAXIAS
    ESTUDIO DE EFICACIA, TOLERANCIA Y SEGURIDAD DEL TRATAMIENTO CON AMANTADINA EN LAS ATAXIAS DEGENERATIVAS
    A.4.1Sponsor's protocol code numberARPA-AMANTADINA-2012
    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 SponsorFIBHULP
    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 supportMinisterio de Sanidad, Política Social e Igualdad
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFIBHULP
    B.5.2Functional name of contact pointMaria Yllescas
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de la Castellana 261
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28046
    B.5.3.4CountrySpain
    B.5.4Telephone number+34917277558
    B.5.5Fax number+34912071876
    B.5.6E-mailmaria.yllescas@idipaz.es
    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.2.1.2Country 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.3.1Product nameAmantadina
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    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 768-94-5
    D.3.9.3Other descriptive nameAMANTADINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB00422MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number100 to 300
    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.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 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 placeboCapsule, hard
    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
    Degenerative ataxias
    Ataxias degenerativas
    E.1.1.1Medical condition in easily understood language
    Degenerative disease of the cerebellum
    Enfermedad degenerativa del cerebelo
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the efficacy of amantadine in patients with degenerative ataxias mild to moderate, as mediating the SARA scale. Determine changes in blood levels of frataxin levels in patients with degenerative ataxias mild to moderate before and after starting treatment. Objectives of safety and tolerance.
    Determinar la eficacia de amantadina en pacientes con ataxias degenerativas de grado leve a moderado, medida mediantes la escala SARA. Determinar los cambios en los niveles en sangre los niveles de frataxina en pacientes con ataxias degenerativas de grado leve a moderado, antes y después de iniciado el tratamiento. Objetivos de seguridad y tolerancia.
    E.2.2Secondary objectives of the trial
    - Echocardiography in the case of patients with Friedreich's Ataxia
    - Neuro-ophthalmology rating
    - Visual evoked potentials
    - Otoneurological review
    - Brain MRI
    - Determine changes in blood levels of IGF-1 and fratraxina in patients with Friedreich's ataxia mild to moderate before and after starting treatment.
    - Ecocardiograma en el caso de los pacientes con Ataxia de Friedreich
    - Valoración neuro-oftalmológica
    - Potenciales evocados visuales
    - Examen otoneurológico
    - RM cerebral
    - Determinar los cambios en los niveles en sangre de IGF-1 y fratraxina en pacientes con ataxia de Friedreich de grado leve a moderado, antes y después de iniciado el tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age equal or greater than 18 and less than 85 years
    - Patients with degenerative ataxias with scores between 8 and 34 points on the SARA scale
    - Patients with and without cardiomyopathy
    - Can be included patients stably treated with idebenone and / or riboflavin and / or deferiprone or darbepoetin for at least 1 year
    - Having given informed consent
    - Edad igual o mayor de 18 años y menor de 85 años
    - Pacientes con ataxias degenerativas con puntuaciones entre 8 y 34 puntos en la escala SARA
    - Pacientes con y sin miocardiopatía
    - Pueden ser incluidos pacientes en tratamiento estable con idebenona y/o riboflavina y/o deferiprona o darbepoetina durante al menos 1 año
    - Haber dado su consentimiento informado
    E.4Principal exclusion criteria
    - Age under 18 or over 85 years
    - SARA Scale score <8 and> 34 points
    - Impared to proximal level muscle strength of lower extremity in a grade ? 4 points in the Gradual Neurological Scale
    - Sensory function (primary modes + estereognosia) altered at a rate of ? 9 Gradual Neurological Scale
    - Significant neurological disease that may affect cognition: dementia, Down syndrome
    - Current presence of disorder or clinically significant psychiatric symptoms (eg hallucinations), according to the criteria of the "Diagnostic and Statistical Manual of Mental Disorders", Fourth Edition (DSM-IV), which may affect the patient's ability to complete the study.
    - Edad menor de 18 o mayor de 85 años
    - Puntuación en la escala SARA <8 y >34 puntos
    - Fuerza muscular alterada a nivel proximal de las extremidades inferiores en un grado ?4 puntos en la Escala Neurológica Gradual
    - Funcion sensitiva (modalidades primarias + estereognosia) alterada en un grado de ?9 en la Escala Neurológica Gradual
    - Enfermedad neurológica significativa que pueda afectar la cognición: demencias, síndrome de Down
    - Presencia actual de trastorno o síntoma (por ejemplo, alucinaciones) psiquiátrico mayor clínicamente significativo, de acuerdo con los criterios del "Diagnostic and Statistical Manual of Mental Disorders", Cuarta Edición (DSM-IV), que pueda afectar a la capacidad del paciente para completar el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Neurological assessment
    Otoneurological review
    Evaluacion neruológica
    Estudio otoneurologico
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 meses
    E.5.2Secondary end point(s)
    - Brain MRI
    Neuro-ophthalmology rating
    - Resonancia magnética
    - Valoración neuro-oftalmológica
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months
    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 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 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 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
    LVLS
    Ultima visita del último paciente incluido en el ensayo
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months12
    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 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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    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 state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 150
    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)
    Pending
    Pendiente
    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 Decision2012-10-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-08-06
    P. End of Trial
    P.End of Trial StatusCompleted
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