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    The EU Clinical Trials Register currently displays   43801   clinical trials with a EudraCT protocol, of which   7263   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:2016-000602-10
    Sponsor's Protocol Code Number:SNT-III-012
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-02-06
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2016-000602-10
    A.3Full title of the trial
    A Phase III Double-blind, Randomized, Placebo-Controlled Study
    assessing the Efficacy, Safety and Tolerability of Idebenone in
    Patients with Duchenne Muscular Dystrophy Receiving Glucocorticoid
    Steroids
    Studio di fase III, randomizzato, in doppio cieco, controllato con placebo per valutare l'efficacia, la sicurezza e la tollerabilità di idebenone in pazienti affetti da distrofia muscolare di Duchenne (DMD) che assumono glucocorticosteroidi
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to assess how effective and safe is idebenone treatment in
    patients with Duchenne Muscular Dystrophy (DMD) who are currently
    receiving Glucocorticoid steroids
    Studio di fase III, randomizzato, in doppio cieco, controllato con placebo per valutare l'efficacia, la sicurezza e la tollerabilità di idebenone in pazienti affetti da distrofia muscolare di Duchenne (DMD) che assumono glucocorticosteroidi
    A.3.2Name or abbreviated title of the trial where available
    SIDEROS
    SIDEROS
    A.4.1Sponsor's protocol code numberSNT-III-012
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02814019
    A.5.4Other Identifiers
    Name:US INDNumber:103801
    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 SponsorSANTHERA PHARMACEUTICALS
    B.1.3.4CountrySwitzerland
    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 supportSanthera Pharmaceuticals (Switzerland) Limited
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanthera Pharmaceuticals (Switzerland) Limited
    B.5.2Functional name of contact pointIrina Coserea
    B.5.3 Address:
    B.5.3.1Street AddressHammerstrasse 49
    B.5.3.2Town/ cityLiestal
    B.5.3.3Post codeCH-4410
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41 61 906 8938
    B.5.5Fax number+41 61 9068951
    B.5.6E-mailIrina.Coserea@santhera.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 RAXONE - 150 MG- COMPRESSE RIVESTITE CON FILM- USO ORALE- FLACONE (HDPE)- 180 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderSANTHERA PHARMACEUTICALS (DEUTSCHLAND) GMBH
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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/3/07/437
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIDEBENONE
    D.3.9.1CAS number 58186-27-9
    D.3.9.2Current sponsor codeIDEBENONE
    D.3.9.3Other descriptive nameIDEBENONE
    D.3.9.4EV Substance CodeSUB08114MIG
    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) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Duchenne Muscular Dystrophy (DMD)
    Distrofia muscolare di Duchenne
    E.1.1.1Medical condition in easily understood language
    DMD is a genetic disease characterised by rapidly progressive muscle
    weakness and wasting which leads to severe disability
    Distrofia muscolare di Duchenne
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10013801
    E.1.2Term Duchenne muscular dystrophy
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of idebenone compared to placebo, in delaying
    the loss of respiratory function in patients with DMD receiving
    glucocorticoid steroids as measured by changes in Forced Vital Capacity
    percent predicted (FVC %p) using hospital-based spirometry
    • Valutare l'efficacia di idebenone rispetto al placebo nel rallentamento della perdita di funzionalità respiratoria in pazienti con DMD che assumono glucocorticosteroidi, misurata in base alle variazioni del valore percentuale atteso della capacità vitale forzata (FVC %p) mediante spirometria ambulatoriale.
    E.2.2Secondary objectives of the trial
     To assess the efficacy of idebenone compared to placebo in delaying
    the loss of respiratory function in patients with DMD receiving
    glucocorticoid steroids as measured by:
     Changes in Peak Expiratory Flow percent predicted (PEF %p) using
    hospital-based spirometry
     Time to loss of 10% of Baseline Forced Vital Capacity (FVC) using
    hospital-based spirometry
     To assess the efficacy of idebenone compared to placebo in delaying
    the loss of inspiratory muscle function as measured by changes in
    Inspiratory Flow Reserve (IFR) using hospital-based spirometry
    • Valutare l'efficacia di idebenone rispetto al placebo nel rallentare la perdita di funzionalità respiratoria in pazienti con DMD che assumono glucocorticosteroidi, misurata in base a:

    • Variazione della percentuale prevista del picco di flusso espiratorio (PEF %p) valutata mediante spirometria ambulatoriale

    • Tempo trascorso fino alla perdita del 10% della capacità vitale forzata (FVC) alla Baseline, misurato mediante spirometria ambulatoriale

    • Valutare l’efficacia di idebenone rispetto al placebo nel rallentare la perdita di funzione dei muscoli inspiratori, misurata in base alle variazioni della riserva di flusso inspiratorio (IFR) mediante spirometria ambulatoriale.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    SIDEROS PK SUB STUDY, V0.1, 20Jul2016, To establish the pharmacokinetic profile of idebenone and its metabolites when taken at a dose of 300mg t.i.d in paediatric and adult patients with Duchenne Muscular Dystrophy (DMD) taking glucocorticoid steroids as concomitant therapy
    SIDEROS PK SOTTOSTUDIO, V0.1, 20Jul2016, Per stabilire il profilo farmacocinetico dell'idebenone e dei suoi metaboliti assunto alla dose di 300 mg t.i.d in pazienti pediatrici e adulti affetti da distrofia muscolare di Duchenne (DMD) in terapia concomitante con steroidi glucocorticoidi
    E.3Principal inclusion criteria
    1. Male patients with a 30% ≤ FVC ≤ 80% of predicted value at
    Screening and at Baseline.
    2. Minimum 10 years old at Screening
    3. Signed and dated Informed Consent Form.
    4. Documented diagnosis of DMD (severe dystrophinopathy) and
    clinical features consistent of typical DMD at diagnosis (i.e.
    documented delayed motor skills and muscle weakness by
    age 5 years). DMD should be confirmed by mutation analysis
    in the dystrophin gene or by substantially reduced levels of
    dystrophin protein (i.e. absent or <5% of normal) on Western
    blot or immunostaining.
    5. Chronic use of systemic glucocorticoid steroids for DMD
    related conditions continuously for at least 12 months prior to
    Baseline without any dose adjustments on a mg/kg basis in
    the last 6 months (only dose adjustment determined by weight
    changes are allowed).
    6. Ability to provide reliable and reproducible repeat FVC within
    15% of the screening assessment at Baseline.
    7. Patients assessed by the Investigator as willing and able to
    comply with the requirements of the study, possess the
    required cognitive abilities and are able to swallow study
    medication.
    8. Patients who have been immunized with 23-valent
    pneumococcal polysaccharide vaccine or any other
    pneumococcal polysaccharide vaccine as per national
    recommendations, as well as annually immunized with
    inactivated influenza vaccine.
    1. Pazienti maschi con 30% ≤ FVC ≤ 80% di valore predetto allo Screening e alla Baseline.
    2. minimo 10 anni di età allo screening

    3. Modulo di Consento informato datato e firmato.

    4. Diagnosi documentata di DMD (distrofinopatia grave) e segni clinici coerenti con DMD tipica alla diagnosi (vale a dire, ritardo motorio e debolezza muscolare documentati a insorgenza entro il quinto anno di età). La DMD deve essere confermata mediante analisi mutazionale del gene della distrofina o da livelli significativamente ridotti di proteina distrofina (vale a dire, assente o <5% rispetto alla norma) su Western blot o immunocolorazione.

    5. Uso cronico di glucocorticosteroidi per via sistemica per il trattamento continuativo di condizioni associate a DMD per almeno 12 mesi prima della Baseline senza aggiustamenti posologici su base mg/kg negli ultimi 6 mesi (sono ammessi solo aggiustamenti posologici giustificati da variazioni ponderali).

    6. Capacità di dimostrare ripetutamente una FVC affidabile e riproducibile entro il 15% della valutazione di screening alla Baseline.

    7. Pazienti che a giudizio dello Sperimentatore siano interessati a partecipare allo studio e in grado di soddisfarne i requisiti, in possesso delle abilità cognitive richieste e in grado di ingerire il farmaco dello studio.

    8. Pazienti che siano stati immunizzati con vaccino pneumococcico polisaccaridico 23 valente o qualsiasi altro vaccino pneumococcico polisaccaridico secondo le raccomandazioni nazionali e immunizzati annualmente con vaccino antinfluenzale inattivato (se il paziente ha almeno 6 mesi di età).

    E.4Principal exclusion criteria
    1. Symptomatic heart failure (defined as Stage C by ACCF/AHA
    guideline or NYHA III-IV) and/or symptomatic ventricular
    arrhythmias.
    2. Ongoing participation in any other therapeutic trial and/or
    intake of any investigational drug within 90 days prior to
    Baseline (only exception allowed is use of Deflazacort in US
    as part of the Expanded Access Program).
    3. Prior or ongoing exon-skipping or read-through gene therapy
    for DMD.
    4. Planned or expected spinal fixation surgery during the study
    period (as judged by the Investigator, i.e. due to rapidly
    progressing scoliosis), prior spinal fixation surgery is allowed if
    it took place more than 6 months prior to Screening.
    5. Asthma, bronchitis/COPD, bronchiectasis, emphysema,
    pneumonia or presence of any other non-DMD respiratory
    illness that affects respiratory function.
    6. Chronic use of beta2-agonists or any use of other
    bronchodilating/bronchoconstricting medication (inhaled
    steroids, sympathomimetics, anti-cholinergics, antihistamines);
    chronic use is defined as a daily intake for more than 14 days.
    7. Any bronchopulmonary illness that required treatment with
    antibiotics within 3 months prior to Screening.
    8. Moderate or severe hepatic impairment (Child-Pugh class B [7
    to 9 points] or Child-Pugh class C [10 to 15 points]) or severe
    renal impairment (eGFR <30 mL/min/1.73 m2).
    9. Prior or ongoing medical condition or laboratory abnormality
    which in the Investigator’s opinion may put the patient at
    significant risk, may confound the study results or may
    interfere significantly with the patient’s participation in the
    study1.
    10. History of or current drug or alcohol abuse or use of any
    tobacco/marijuana products/smoking.
    11. Known individual hypersensitivity to idebenone or to any of the
    ingredients/excipients of the study medication.
    12. Daytime ventilator assistance (defined as use of any assisted
    ventilation while awake).
    1. Insufficienza cardiaca sintomatica (inquadrabile nello Stadio C secondo la classificazione dell’ACCF/AHA o nello stadio III-IV secondo quella della NYHA) e/o aritmie ventricolari sintomatiche.

    2. Partecipazione in corso ad altri trial terapeutici e/o assunzione di farmaci sperimentali di qualsiasi tipo nei 90 giorni precedenti alla Baseline (con la sola eccezione di Deflazacort negli USA nell’ambito del Programma di accesso allargato).

    3. Terapia genica - precedente o in corso - basata su exon-skipping o read-through per il trattamento della DMD.

    4. Intervento di fissazione vertebrale, programmato o atteso, durante il periodo dello studio (secondo la valutazione dello Sperimentatore, es., in presenza di scoliosi a rapida progressione); sono ammessi interventi di fissazione vertebrale purché effettuati almeno 6 mesi prima dello Screening.

    5. Asma, bronchite/broncopneumopatia cronica ostruttiva, bronchiettasia, enfisema, polmonite o presenza di altre patologie respiratorie diverse dalla DMD che interessano la funzione respiratoria.

    6. Uso cronico di beta2-agonisti o qualsiasi uso di altri farmaci broncodilatatori/broncocostrittori (steroidi per via inalatoria, simpaticomimetici, anticolinergici, antistaminici); l’uso cronico è definito come assunzione giornaliera per un periodo superiore a 14 giorni.

    7. Patologie broncopolmonari che abbiano richiesto il trattamento con antibiotici nei 3 mesi precedenti allo Screening.

    8. Insufficienza epatica da moderata a severa (rispettivamente in classe B [da 7 a 9 punti] o in classe C [da 10 a 15 punti] secondo la classificazione di Child-Pugh) o grave insufficienza renale (eGFR <30 mL/min/1,73 m2).

    9. Condizione medica o valori di laboratorio anomali - precedenti o attuali - che, giudizio dello Sperimentatore, possano rappresentare un rischio significativo per il paziente, confondere i risultati dello studio o interferire in maniera sostanziale con la partecipazione del paziente allo studio1.
    10. Storia di abuso o abuso attuale di sostanze stupefacenti o di alcolici o di qualsiasi prodotto a base di tabacco o marijuana o simili.

    11. Ipersensibilità individuale nota a idebenone o a qualsiasi ingrediente/eccipiente del farmaco dello studio.

    12. Assistenza ventilatoria durante il giorno (definita come ricorso a qualsiasi tipo di
    E.5 End points
    E.5.1Primary end point(s)
    • The change from Baseline to Week 78 in FVC %p assessed by
    hospital-based spirometry measurements
    • Variazione della FVC %p fra la Baseline e la Settimana 78, valutata mediante spirometria ambulatoriale
    E.5.1.1Timepoint(s) of evaluation of this end point
    78 weeks
    78 weeks
    E.5.2Secondary end point(s)
    The secondary endpoints will be evaluated in the following order in a
    hierarchical manner:
    • The change from Baseline to Week 78 in PEF %p assessed by
    hospital-based spirometry measurements
    • The time to first 10% decline in FVC (L) during the 78-week
    treatment period, assessed by hospital-based spirometry
    measurements
    • The change from Baseline to Week 78 in IFR assessed by
    hospital-based spirometry measurements
    Gli endpoint secondari saranno valutati gerarchicamente nell’ordine seguente:
    • Variazione del PEF %p fra la Baseline e la Settimana 78, valutata mediante spirometria ambulatoriale

    • Tempo trascorso fino al primo declino del 10% della FVC (L) durante il periodo di trattamento di 78 settimane, valutato mediante spirometria ambulatoriale

    • Variazione dell’IFR fra la Baseline e la Settimana 78, valutata mediante spirometria ambulatoriale
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoint 1: 78 weeks
    Secondary endpoint 2: 13, 26, 39, 52, 65 and 78 weeks
    Secondary endpoint 3: 78 weeks
    Secondary endpoint 1: 78 weeks
    Secondary endpoint 2: 13, 26, 39, 52, 65 and 78 weeks
    Secondary endpoint 3: 78 weeks
    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 Yes
    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) 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.8.2.4Number of treatment arms in the trial2
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    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
    Austria
    Belgium
    France
    Germany
    Italy
    Netherlands
    Spain
    Sweden
    Switzerland
    United Kingdom
    United States
    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
    LVLS
    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 months40
    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 months40
    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 Yes
    F.1.1Number of subjects for this age range: 1
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 26
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 200
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 0
    F.2 Gender
    F.2.1Female No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    DMD is mainly diagnosed in the first decade of life and therefore
    patients below the age of consent are expected to be enrolled into the
    trial
    DMD is mainly diagnosed in the first decade of life and therefore
    patients below the age of consent are expected to be enrolled into the
    trial
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state81
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 130
    F.4.2.2In the whole clinical trial 266
    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)
    All patients completing Visit 8/Week 78, and considered eligible by the
    Investigator will be able to participate in an open-label extension study
    (SIDEROS-E) and will continue to receive idebenone until the SIDEROSE
    is terminated or Marketing Authorization is obtained for idebenone in
    DMD, whichever occurs first.
    All patients completing Visit 8/Week 78, and considered eligible by the
    Investigator will be able to participate in an open-label extension study
    (SIDEROS-E) and will continue to receive idebenone until the SIDEROSE
    is terminated or Marketing Authorization is obtained for idebenone in
    DMD, whichever occurs first.
    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 Decision2016-10-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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