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    Summary
    EudraCT Number:2019-004256-11
    Sponsor's Protocol Code Number:MT-1186-A02
    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:2021-05-24
    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 number2019-004256-11
    A.3Full title of the trial
    A Phase 3b, Multicenter, Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Oral Edaravone Administered for a Period of 48 Weeks in Subjects with Amyotrophic Lateral Sclerosis (ALS)
    Studio di Fase 3b, multicentrico, randomizzato, in doppio cieco per valutare l’efficacia e la sicurezza di edaravone orale somministrato per un periodo di 48 settimane a soggetti con sclerosi laterale amiotrofica (SLA).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Efficacy and Safety Study of Oral Edaravone in Subjects with Amyotrophic Lateral Sclerosis (ALS)
    Studio sulla sicurezza e sull'efficacia di edaravone orale in soggetti con sclerosi laterale amiotrofica (SLA).
    A.3.2Name or abbreviated title of the trial where available
    N/A
    N/A
    A.4.1Sponsor's protocol code numberMT-1186-A02
    A.5.4Other Identifiers
    Name:IND numberNumber:138145
    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 SponsorMitsubishi Tanabe Development America Inc.
    B.1.3.4CountryUnited States
    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 supportMitsubishi Tanabe Pharma Development America, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMitsubishi Tanabe Pharma Development America, Inc.
    B.5.2Functional name of contact pointDaniel Selness
    B.5.3 Address:
    B.5.3.1Street Address525 Washington Boulevard, Suite 400
    B.5.3.2Town/ cityJersey City
    B.5.3.3Post codeNJ 07310
    B.5.3.4CountryUnited States
    B.5.4Telephone number0014147048829
    B.5.5Fax number0014147048829
    B.5.6E-maildaniel_selness@mt-pharma-us.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 No
    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 nameEdaravone
    D.3.2Product code [MT-1186]
    D.3.4Pharmaceutical form Oral suspension
    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 89-25-8
    D.3.9.2Current sponsor codeMT-1186
    D.3.9.4EV Substance CodeSUB06453MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number21
    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
    D.8.3Pharmaceutical form of the placeboOral suspension
    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
    Amyotrophic Lateral Sclerosis (ALS)
    Sclerosi Laterale Amiotrofica (SLA)
    E.1.1.1Medical condition in easily understood language
    A disease that affects nerve cells in the brain and the spinal cord
    Una malattia che colpisce le cellule nervose del cervello e del midollo spinale
    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 21.1
    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
    To evaluate and compare the efficacy of the following two dosing regimens of oral edaravone in subjects with amyotrophic lateral sclerosis (ALS) based on the change in ALS Functional Rating Scale-
    Revised (ALSFRS-R) score from baseline up to Week 48:
    - Oral edaravone 105 mg administered once daily (regimen denoted as daily) in Cycles 1 through 12
    - Oral edaravone 105 mg administered for 14 days, followed by placebo for 14 days in Cycle 1, and subsequently, repeat oral edaravone 105 mg administered for 10 days followed by placebo for 18 days (regimen denoted as on/off) in Cycles 2 through 12.
    Valutare e confrontare l’efficacia dei seguenti due regimi di dosaggio di edaravone orale in soggetti con sclerosi laterale amiotrofica (SLA) in base al cambiamento nel punteggio dell’ALS Functional Rating Scale- Revised (ALSFRS-R) dal basale fino alla settimana 48:
    - edaravone orale 105 mg somministrato una volta al giorno (regime indicato come giornaliero) nei cicli 1-12;
    - edaravone orale 105 mg somministrato per 14 giorni, seguito da placebo per 14 giorni nel ciclo 1 e successivamente, ripetere edaravone orale 105 mg somministrato per 10 giorni seguito da placebo per 18 giorni (regime indicato come on/off) nei cicli 2-12.
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of oral edaravone at a dose of 105 mg once daily compared to oral edaravone at a dose of 105 mg including placebo (regimen denoted as on/off) in subjects with ALS over 48 weeks.
    Valutare la sicurezza e la tollerabilità di edaravone orale a una dose di 105 mg una volta al giorno rispetto a edaravone orale a una dose di 105 mg incluso placebo (regime indicato come on/off) in soggetti con SLA in 48 settimane
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects must provide a signed and dated informed consent form (ICF) to participate in the study. Subjects must be able (in the judgment of the Investigator) to understand the nature of the study and all risks involved with participation in the study. Subjects must be willing to cooperate and comply with all protocol restrictions and requirements.
    2. Subjects will be male or female, = 18 to 75 years of age at the time the ICF is signed.
    3. Subjects will be diagnosed with Definite ALS or Probable ALS according to the El Escorial revised criteria for the diagnosis of ALS.
    4. Subjects with a baseline score = 2 points on each individual item of the ALSFRS- R at screening and baseline visits
    5. Subjects have a screening and baseline %forced vital capacity (FVC) =70%.
    6. Subjects with 1 to 4 points decline for 8 weeks in ALSFRS-R total
    score between screening and baseline visits.
    7. Subjects whose first symptom of ALS has occurred within 2 years of
    providing written informed consent.
    1. Per partecipare allo studio, i soggetti devono fornire un modulo di consenso informato (ICF) datato e firmato. I soggetti devono essere in grado (secondo il parere dello Sperimentatore) di comprendere la natura dello studio e tutti i rischi che comporta la partecipazione allo studio. I soggetti devono essere disposti a collaborare e rispettare tutte le restrizioni e i requisiti del protocollo.
    2. I soggetti saranno pazienti di sesso maschile o femminile di età compresa fra =18 anni e 75 anni al momento della firma dell’ICF.
    3. I soggetti devono avere una diagnosi di SLA certa o probabile secondo i criteri rivisti El Escorial per la diagnosi di SLA.
    4. Soggetti con un punteggio basale di =2 punti su ciascun item individuale dell’ALSFRS alla visita di screening e basale.
    5. I soggetti hanno una percentuale di capacità vitale forzata (FVC) al basale e allo screening di =70%.
    6. Soggetti con un declino di 1-4 punti per 8 settimane nel punteggio totale ALSFRS-R tra le visite di screening e basale.
    7. Soggetti i cui sintomi iniziali della SLA si sono manifestati entro 2 anni dal consenso informato scritto.
    E.4Principal exclusion criteria
    Exclusions Related to Primary Diagnosis
    1. Subjects with a history of spinal surgery after the onset of ALS, such as surgery for cervical spondylosis or a herniated disc, or plans for such surgery during the study period.
    Exclusions Related to Other Neurological Disorders (including, but not limited to the following)
    2. Subjects with the possibility that the current symptoms may be symptoms of a disease requiring differential diagnosis, such as cervical spondylosis and multifocal motor neuropathy, cannot be ruled out.
    Exclusions Related to General Health or Concomitant Conditions
    3. Subjects undergoing treatment for a malignancy.
    4. Subjects with a complication that could have a significant effect on efficacy evaluations, such as Parkinson's disease or syndrome, schizophrenia, bipolar disorder, and dementia.
    5. Subjects who have the presence or history of any clinically significant (CS) disease (except ALS) that could interfere with the objectives of the study (the assessment of safety and efficacy) or the safety of the subject, as judged by the Investigator.
    6. Subjects who are female and pregnant (a positive pregnancy test) or lactating at the screening visit (Visit 1).
    7. Subjects of childbearing potential unwilling to use acceptable method of contraception from the screening visit until 3 months after the last dose of study medication. Subjects who are sexually active who do not agree to use contraception during the study period. Refer to Appendix 3 for additional contraceptive information.
    8. Subjects who have a significant risk of suicidality. Subjects with any suicidal behavior or suicidal ideation of type 4 (active suicidal ideation with some intent to act, without a specific plan) or type 5 (active suicidal ideation with specific plan and intent) based on the Columbia–Suicide
    Severity Rating Scale (C-SSRS) within the 3 months before the screening visit.
    9. Subjects who have alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevations greater than 2 times the upper limit of normal (ULN) at screening.
    10. Subjects with a Glomerular Filtration Rate (GFR) < 30 mL/Min Per 1.73 m2 at screening, using the Larsson Equation.
    Exclusions Related to Medications
    11. Subjects with history of hypersensitivity to edaravone, any of the additives or inactive ingredients of edaravone, or sulfites.
    12. Subjects with hereditary problems of fructose intolerance (eg, fructose, sucrose, invert sugar, and sorbitol).
    13. Subjects who participated in another study and were administered an investigational product within 1 month or 5 half-lives of the investigational agent, whichever is longer, before providing informed consent for the present study.
    14. Subjects who have received any previous treatment with edaravone.
    15. Subjects who have received stem cell therapy.
    16. Subjects who are unable to take their medications orally at baseline
    (Visit 2).
    Esclusioni correlate alla diagnosi primaria
    1. Soggetti con anamnesi di chirurgia spinale dopo l’insorgenza della SLA, come intervento per spondilosi cervicale o ernia al disco, o previsione di tali interventi durante il periodo dello studio.
    Esclusioni correlate ad altri disturbi neurologici (inclusi a titolo esemplificativo, i seguenti)
    2. I soggetti per cui esiste la possibilità che i sintomi attuali possano essere sintomi di una malattia che richiede una diagnosi differenziale, come spondilosi cervicale e neuropatia motoria multifocale non possono essere esclusi. Esclusioni correlate allo stato di salute generale o a condizioni concomitanti
    3. Soggetti sottoposti a trattamento per tumore maligno.
    4. Soggetti con una complicazione che potrebbe avere un effetto significativo sulle valutazioni dell’efficacia, come sindrome parkinsoniana o malattia di Parkinson, schizofrenia, disturbo bipolare o demenza.
    5. Soggetti con presenza o anamnesi di malattia clinicamente significativa (CS) (ad eccezione della SLA) che potrebbe interferire con gli obiettivi dello studio (la valutazione dell’efficacia e della sicurezza) o la sicurezza del soggetto, secondo il parere dello Sperimentatore.
    6. Soggetti di sesso femminile in stato di gravidanza (con test di gravidanza positivo) o che allattano al seno alla visita di screening (Visita 1).
    7. Soggetti in età fertile che non vogliono utilizzare un metodo contraccettivo accettabile dalla visita di screening fino a 3 mesi dopo l’ultima dose del farmaco in studio. Soggetti sessualmente attivi che non accettano di utilizzare metodi contraccettivi durante il periodo dello studio. Fare riferimento all’Allegato 3 per ulteriori informazioni sui metodi contraccettivi.
    8. Soggetti con un rischio significativo di suicidalità. Soggetti con comportamenti suicidi o ideazione suicidaria di tipo 4 (ideazione attiva con qualche intenzione di agire, senza un piano specifico) o di tipo 5 (ideazione suicidaria attiva con un piano specifico e con intenzione) in base alla scala della Columbia University per la valutazione della gravità del rischio di suicidio (C-SSRS) entro i 3 mesi precedenti la visita di screening.
    9. Soggetti con elevazioni dell’alanina aminotransferasi (ALT) oppure dell’aspartato aminotransferasi (AST) 2 volte superiori al limite superiore della norma (ULN) allo screening.
    10. Soggetti con velocità di filtrazione glomerulare (GFR) <30 ml/min per 1,73m2 allo screening, utilizzando l’equazione di Larsson. Esclusioni correlate ai farmaci
    11. Soggetti con anamnesi di ipersensibilità a edaravone, qualsiasi additivo o ingrediente attivo di edaravone, o solfiti.
    12. Soggetti con problemi ereditari di intolleranza al fruttosio (es. fruttosio, saccarosio, zucchero invertito e sorbitolo).
    13. Soggetti che hanno partecipato a un altro studio e hanno ricevuto un prodotto sperimentale entro 1 mese o 5 emivite dell’agente sperimentale, a seconda del periodo più lungo, prima di fornire il consenso informato per il presente studio.
    14. Soggetti che hanno ricevuto qualsiasi trattamento precedente con edaravone.
    15. Soggetti che hanno ricevuto terapia con cellule staminali.
    16. Soggetti che non sono in grado di assumere i propri farmaci oralmente al basale (Visita 2).
    E.5 End points
    E.5.1Primary end point(s)
    Change in ALSFRS-R score from baseline to Week 48 of treatment
    Variazione nel punteggio ALSFRS-R dal basale alla Settimana 48 di trattamento
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of treatment visit number 15 (week 48)
    Visita di fine trattamento numero 15 (settimana 48)
    E.5.2Secondary end point(s)
    Key Secondary Efficacy Endpoints are:
    - Change from baseline in % slow vital capacity (SVC) at Week 48
    - Change from baseline in Amyotrophic Lateral Sclerosis Assessment
    Questionnaire (ALSAQ)40 at Week 48
    - Time to death, tracheostomy or permanent assisted mechanical
    ventilation (= 23 hours/day)
    Other Secondary Endpoints:
    - Change from baseline in ALSFRS-R score at Weeks 4, 8, 12, 24, and 36
    - Change from screening and baseline in %FVC at Weeks 24 and 48
    - Change from baseline in %SVC at Weeks 4, 8, 12, 24, and 36
    - Change from baseline in ALSAQ40 to Week 24
    - Change from baseline in body weight score at Weeks 4, 8, 12, 24, 36,
    and 48
    - The Combined Assessment of Function and Survival (CAFS) score at
    Weeks 24 and 48
    - King's ALS Clinical Stage derived from ALSFRS-R score and death
    Gli endpoint di efficacia secondari principali sono:
    - Variazione dal basale della % di capacità vitale lenta (SVC) alla settimana 48
    - Variazione dal basale del Questionario di valutazione della sclerosi laterale amiotrofica (ALSAQ)40 alla Settimana 48
    - Tempo al decesso, tracheostomia o ventilazione meccanica assistita permanente (=23 ore/giorno)
    Altri endpoint secondari:
    - Variazione dal basale del punteggio ALSFRS-R alla Settimana 4, 8, 12, 24 e 36
    - Variazione dallo screening e dal basale della %FVC alla Settimana 24 e 48
    - Variazione dal basale della %SVC alla Settimana 4, 8, 12, 24 e 36
    - Variazione dal basale dell’ALSAQ40 alla Settimana 24
    - Variazione dal basale del punteggio relativo al peso corporeo alla Settimana 4, 8, 12, 24, 36 e 48
    - Il punteggio CAFS (Combined Assessment of Function and Survival) alla Settimana 24 e 48
    Stadio clinico SLA di King derivato dal punteggio ALSFRS-R e decesso
    E.5.2.1Timepoint(s) of evaluation of this end point
    At various timepoints throughout the study as described above.
    In vari punti temporali durante lo studio come descritto in precedenza.
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 No
    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 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 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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
    Canada
    Japan
    Korea, Republic of
    United States
    France
    Germany
    Italy
    Switzerland
    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 years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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: 190
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 190
    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
    Male subjects with partners of child-bearing potential using contraception
    Soggetti maschi con partner in età fertile che utilizzano metodi contraccettivi
    F.4 Planned number of subjects to be included
    F.4.1In the member state31
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 79
    F.4.2.2In the whole clinical trial 380
    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)
    N/A
    N/A
    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 Decision2021-02-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-22
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-07-31
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