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    Summary
    EudraCT Number:2021-004868-95
    Sponsor's Protocol Code Number:FETEM
    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:2021-12-22
    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 number2021-004868-95
    A.3Full title of the trial
    AMANTADINE AND TRANSCRANIAL MAGNETIC STIMULATION FOR TREATING FATIGUE IN MULTIPLE SCLEROSIS: PHASE III STUDY, CONTROLLED, RANDOMIZED, CROSSED OVER AND DOUBLE BLIND
    AMANTADINA Y ESTIMULACIÓN MAGNÉTICA TRANSCRANEAL PARA FATIGA EN LA ESCLEROSIS
    MULTIPLE: ENSAYO FASE III, CONTROLADO, RANDOMIZADO, CRUZADO Y DOBLE CIEGO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    AMANTADINE AND TRANSCRANIAL MAGNETIC STIMULATION FOR TREATING FATIGUE IN MULTIPLE SCLEROSIS
    AMANTADINA Y ESTIMULACIÓN MAGNÉTICA TRANSCRANEAL PARA FATIGA EN LA ESCLEROSIS
    MULTIPLE
    A.3.2Name or abbreviated title of the trial where available
    FETEM
    FETEM
    A.4.1Sponsor's protocol code numberFETEM
    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 SponsorFundación para la Inv. Biomédica Hospital Clínico San Carlos
    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 supportINSTITUTO CARLOS III
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundación para la Investigación Biomédica del Hospital Clínico San Carlos
    B.5.2Functional name of contact pointUICEC IdICSC
    B.5.3 Address:
    B.5.3.1Street AddressC/ Prof Martin Lagos s/n
    B.5.3.2Town/ cityMADRID
    B.5.3.3Post code28040
    B.5.3.4CountrySpain
    B.5.4Telephone number+349133030007360
    B.5.5Fax number+34913303515
    B.5.6E-mailfibucicec.hcsc@salud.madrid.org
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Amantadine Level
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratorios ERN, 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.3.1Product nameAmantadine
    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.3.8INN - Proposed INNINN
    D.3.9.1CAS number 768-94-5
    D.3.9.2Current sponsor codetest1
    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 200
    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 placeboBuccal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Fatigue in multiple sclerosis
    fatiga en esclerosis múltiple
    E.1.1.1Medical condition in easily understood language
    Fatigue in multiple sclerosis
    fatiga en esclerosis múltiple
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the fatigue severity in patients with multiple sclerosis treated with amantadine, TMS or their combination in combination with placebo.
    evaluar el cambio en la severidad de la fatiga en los pacientes con EM sometidos a tratamiento con amantadina, TMS y ambos en combinación, en comparación con placebo.
    E.2.2Secondary objectives of the trial
    To assess the congnitive, depresion conditions and quality of live, a validated scale will be used for each aims. Thefore, it will be carried out a cost-effectivity and safety assement.
    evaluarán cambios en cognición, depresión y calidad de vida. Para todo ello se utilizarán las escalas de referencia adecuadamente validadas para
    cada uno de los objetivos. Asimismo, se realizara un análisis de seguridad y de coste-efectividad
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Expanded Disability Status Scale mark 1.5 - 4.5
    2. Fatigue Severity Scale > 4
    3. Beck Depression Inventory < 19
    4. Drug washout period = 4 weeks for any fatigue aimed drug
    5. No relapse for, at least, a month prior to screening
    Criterios de inclusión: 1. Puntuación de escala de discapacidad (EDSS) en el momento del reclutamiento (1, 5 a 4,5 puntos). 2. Puntuación en la Fatigue Severity Scale (FSS) mayor a 4 puntos 3. Puntación en Beck Depression Inventory (BDI) menor de 19 puntos 4. Haberse realizado un lavado de cuatro semanas para cualquier fármaco relacionado con la fatiga: amantadina, modafinilo, metilfenidato, acetil-L-carnitina, cannabinol (delta-9-tetrahidrocannabinol y cannabidiol de Cannabis sativa L) y fampridina. 5. No haber presentado un brote de la enfermedad en, al menos, un mes antes del reclutamiento.
    E.4Principal exclusion criteria
    1. Fatigue causing disease other than multiple sclerosis
    2. Sleep apnea treated with CPAP devices
    3. Other autoimmune disease which might cause fatigue
    4. Cronic Fatigue Syndrome
    5. Secondary Epilepsy or neuropathic cronic pain which requires continuous treatment.
    6. High blood pressure out of control or cardiac condition.
    1. Fatiga derivada de cualquier otra enfermedad diferente a esclerosis múltiple
    2. Apnea del sueño tratada con dispositivo CPAP
    3. Otras enfermedades autoinmunes las cuales causen fatiga
    4. Síndrome de fatiga crónica
    5. Epilepsia secundaria o dolor por neuropatía crónica los cuales requieren tratamiento continuado.
    6. Presión sanguínea alta no controlada o alteración cardiaca.
    E.5 End points
    E.5.1Primary end point(s)
    Compare clinical response to amantadine, TMS or the combination
    comparar la respuesta clínica de amantadine, TMS o su combinación
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 6 weeks of treatment
    después de 6 semanas de tratamiento
    E.5.2Secondary end point(s)
    1. Cognitive recovery measured by SDMT test
    2. Depression measured with Beck's scale
    3. Life quality measured with SF-12 scale.
    4. Safety
    5. Cost-effectiviness
    1. Medidas de mejora congnitiva (test SDMT)
    2. Medidas de depresión (Scala Beck)
    3. Calidad de vida (Scala SF-12)
    4. Seguridad
    5- Costa/efectividad

    E.5.2.1Timepoint(s) of evaluation of this end point
    After 6 weeks of treatment
    Después de 6 semanas de tratamiento
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 No
    E.8.1.6Cross over Yes
    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
    Transcranial magnetic stimulation
    E.8.2.4Number of treatment arms in the trial4
    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 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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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: 144
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 144
    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 Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state144
    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)
    Follow up as per clinical practice
    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 Decision2022-05-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-05-24
    P. End of Trial
    P.End of Trial StatusOngoing
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