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    Summary
    EudraCT Number:2015-002125-19
    Sponsor's Protocol Code Number:9494
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Suspended by CA
    Date on which this record was first entered in the EudraCT database:2016-05-18
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2015-002125-19
    A.3Full title of the trial
    A phase IIb, prospective, multicentre, double-blind, triple-arm, randomized versus placebo trial, to assess the efficacy of a single injection of either 2 or 10 x 106 autologous adipose derived mesenchymal stromal cells (ASC) in the treatment of mild to moderate osteoarthritis (OA) of the knee, active and unresponsive to conservative therapy for at least 12 months.
    Studio di fase IIb, prospettico, multicentrico, in doppio cieco, a tre bracci, randomizzato verso placebo, per valutare l’efficacia di una singola iniezione di 2 o 10 x 106 cellule stromali mesenchimali derivate da tessuto adiposo autologo (ASC) nel trattamento dell’artrosi di ginocchio da lieve a moderata , in fase acuta e non responsiva ad almeno 12 mesi di terapia standard
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase 2b Study Evaluating the Efficacy of a Single Injection Autologous Adipose Derived Mesenchymal Stromal Cells in Patients with Knee Osteoarthritis
    “Singola iniezione nell'articolazione del ginocchio di pazienti affetti da artrosi moderata
    (malattia delle articolazioni che peggiora nel tempo caratterizzata dalla formazione di nuovo tessuto attorno alla zona interessata) di cellule capaci di trasformarsi in diversi altri tipi di cellule del corpo derivate dal tessuto adiposo prelevato precedentemente dallo stesso paziente ricevente”
    A.3.2Name or abbreviated title of the trial where available
    ADIPOA 2
    ADIPOA 2
    A.4.1Sponsor's protocol code number9494
    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 SponsorCHU MontpellierCentre administratif André Benech,
    B.1.3.4CountryFrance
    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 supportH2020-PHC-2014-single-stage
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU Montpellier
    B.5.2Functional name of contact pointChristian JORGENSEN
    B.5.3 Address:
    B.5.3.1Street AddressHôpital Lepyronie, 191, avenue du Doyen gaston Giraud
    B.5.3.2Town/ cityMontpellier cedex 5
    B.5.3.3Post code34295
    B.5.3.4CountryFrance
    B.5.4Telephone number330467337796
    B.5.5Fax number330467337227
    B.5.6E-mailc-jorgensen@chu-montpellier.fr
    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 nameautologous adipose derived mesenchymal stromal cells
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarticular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNA
    D.3.9.1CAS number NA
    D.3.9.3Other descriptive nameEXPANDED HUMAN AUTOLOGOUS MESENCHYMAL ADULT STEM CELLS EXTRACTED FROM ADIPOSE TISSUE (EASCS)
    D.3.9.4EV Substance CodeSUB30158
    D.3.10 Strength
    D.3.10.1Concentration unit million organisms/ml million organisms/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2000000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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) Yes
    D.3.11.3.1Somatic cell therapy medicinal product Yes
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Yes
    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.IMP: 2
    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 nameAutologous adipose derived mesenchymal stromal cells
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarticular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNA
    D.3.9.1CAS number NA
    D.3.9.3Other descriptive nameEXPANDED HUMAN ALLOGENEIC MESENCHYMAL ADULT STEM CELLS EXTRACTED FROM ADIPOSE TISSUE
    D.3.9.4EV Substance CodeSUB30305
    D.3.10 Strength
    D.3.10.1Concentration unit million organisms/ml million organisms/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10000000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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) Yes
    D.3.11.3.1Somatic cell therapy medicinal product Yes
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Yes
    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 placeboSuspension for injection
    D.8.4Route of administration of the placeboIntraarticular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Active knee Osteoarthritis (mild to moderate)
    Artrosi in fase acuta da lieve a moderata
    E.1.1.1Medical condition in easily understood language
    Osteoarthritis
    Malattia delle articolazioni che peggiora nel tempo caratterizzata dalla formazione di nuovo tessuto attorno alla zona interessata
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    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
    Evaluate the efficacy of a single intra-articular injection of ASC in mild to moderate knee OA (KL 2-3) based on improvement of WOMAC pain and function subscore at 6 month, compared to placebo (vehic: 0.5% glucose in saline with 4% alb)
    Valutare l’efficacia di una singola iniezione intra-articolare di ASC nell’artrosi di ginocchio da lieve a moderata OA (Kellgren Lawrence 2-3) basata sull’incremento del numero dei pazienti strettamente responsivi (strict responders) definiti tali mediante i miglioramenti rispetto al baseline del dolore e della funzionalità fisica secondo il sottopunteggio 50% WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index), con variazioni assolute di 20 mm a 6 mesi, comparata con placebo (veicolo 0.5% glucosio in soluzione salina con 4.5% alb).
    E.2.2Secondary objectives of the trial
    - Kellgren-Lawrence scores assessment on the basis of X-rays
    - Progression of affected knee joints by quantitative MRI
    - Disability and life quality assessment
    - OARSI response assessment
    - Paracetamol (Acetaminophen) medication assessment
    - Valutazione punteggio Kellgren Lawrence sulla base degli esami radiografici;
    - Progressione del ginocchio interessato definita mediante RMN;
    - Valutazione della disabilità e della qualità della vita;
    - Valutazione della risposta OARSI;
    - Valutazione dell’uso del paracetamolo e di altri antidolorifici.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Symptomatic mild to moderate osteoarthritis (OA) of the index knee as defined by the American college of Rheumatology (ACR):
    - History of pain in the index knee ≥ 6 months, AND
    - Kellgren-Lawrence (K-L) Grade 2 or 3 only, on plain radiographs of the index knee (including fixed flexion), AND
    - Swelling of the index knee evaluated by the investigator
    2. Must meet the following pain criteria at the time of screening/baseline visit since at least half of the days in the previous month:
    - Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscores ≥ 40 mm on the 0-100 normalised scale
    - Visual Analogic Scale (VAS) pain rating of at least 40 on a 100-mm scale
    - Subject’s global assessment of arthritis status must be fair, poor, or very poor
    -Subject’s global assessment of the contralateral knee <20 mm by 100-mm using Visual Analogic Scale (VAS)
    3. NSAID washout of at least 2 days before screening/baseline
    4. BMI between 20-35 kg/m2
    1. Precedenti trattamenti che agiscono sulla cartilagine o sul metabolismo osseo (es bifosfonati orali o endovena <1 anno precente, denosumab < 6 mesi, ranelato di stronzio o teriparatide o raloxifene <7 giorni prima dallo screening)
    2. Glucosamina orale ≥1500 mg/die e condroitinsolfato ≥1000 mg/die <3 mesi prima
    3. Pazienti che abbiano ricevuto iniezioni intra-articolari di corticosteroidi, piastrine ricche di plasma o acido ialuronico nei 6 mesi precedent la visita di screening.
    4. Traumi significativi o operazioni chirurgiche nel ginocchio interessato nel corso dell’ultimo anno o artroscopia del ginocchio entro 12 mesi dallo screening.
    5. Kellgren-Lawrence di grado 1 o 4 nel ginocchio interessato e in qualunque proiezione.
    6. Artrosi causante dolore significativo in qualunque altra sede diversa dal ginocchio interessato, ad esempio dolore all’anca o al ginocchio controlaterale (≥ 20 mm sulla scala del dolore) come confermato dal VAS al baseline per ogni altra articolazione interessata dal dolore .

    7. Storia di protesi del ginocchio o dell’anca nei 12 mesi precedenti.

    8. Diagnosi di una o più dei seguenti:
     Artriti infiammatorie come l’artrite reumatoide, disordini autoimmuni, spondiloartrite sieronegativa, gotta o pseudogotta (definita come attacco acuto di gonfiore, dolore articolare in pazienti con condrocalcinosi o cristalli CPPD ai raggi X); storia o evidenza di artriti infettive, malattia di Paget, Ocronosi, sindrome di Wilson, Osteocondromatosi primaria
     Storia di fratture articolari nel ginocchio interessato
     Storia di disordini ereditari (es ipermobilità) e mutazioni del gene del collagene
     Patologie da immunodeficienza
     Alcolismo non trattato e ancora in corso (+14 bevande alcoliche a settimana)
     Soggetti con diabete mellito scarsamente controllato (HbA1C > 8%) o problemi vascolari concomitanti noti
     Programmati soggiorni prolungati fuori regione che impediscono la compliance per le visite programmate previste
     Grave disallineamento del ginocchio (eccessivamente varo o valgo ≥ 8°) all’esame obiettivo, e alla radiografia standard.
    Grave osteoporosi con precedenti e sintomatiche fratture vertebrali o del femore
    E.4Principal exclusion criteria
    1. Previous treatments acting on cartilage or bone metabolism (eg, oral or intravenous bisphosphonates <1 year previously, strontium ranelate or teriparatide or raloxifene <7 days prior to selection, and oral glucosamine ≥1500 mg/day and chondroitin sulphate <3 months previously)
    2. Prior to the screening visit, has received intra-articular injection of corticosteroids, platelet rich plasma or hyaluronic acid within the previous 6 months,
    3. Significant trauma or surgery to the index knee within the last year or arthroscopy of the index knee within 12 months of screening.
    4. Kellgren-Lawrence Grade 1 or 4 in the index knee.
    5. Osteoarthritis causing significant pain in any joint other than the identified knee, i.e., pain in hip, back, or contralateral knee (≥ 20 mm pain) as confirmed by a separate VAS at baseline for any other painful joint concerned
    6. History of joint replacement of the knee or hip within the 
previous 12 month
    7. Diagnosis of one or more of the following:
    - Inflammatory arthritis such as rheumatoid arthritis, autoimmune disorder, seronegative spondyloarthritis, gout or pseudogout (defined as acute episodic attacks of swollen, painful joint in a patient with X-Ray chondrocalcinosis or CPPD crystals);
    - Severe misalignment of the knee (excessive varus or valgus ≥ 8°) at physical examination, as confirmed by standard radiograph
    - Severe osteoporosis with previous fractures
    1. Artrosi del ginocchio sintomatica da lieve a moderata come definita dai criteri diagnostici dell’ American college of Rheumatology (ACR):
     Storia di dolore nel ginocchio interessato ≥ 6 mesi, E
     Kellgren-Lawrence (K-L) di grado 2 o 3, alle radiografie del ginocchio interessato (inclusa la proiezione in flessione fissa), E
     Tumefazione del ginocchio interessato valutato dallo sperimentatore.

    2. I seguenti requisiti relativi al dolore devono essere soddisfatti al momento della prima visita di screening/baseline da almeno la metà dei giorni del mese precedente:
     Punteggio del dolore ≥ 40 mm su una scala normalizzata da 0-100 mm secondo l’Indice WOMAC
     Valutazione del dolore di almeno 40 mm su una scala fino a 100 mm secondo la Visual Analogic Scale (VAS)
     La valutazione globale del ginocchio controlaterale <20 mm secondo la Visual Analogic Scale (VAS) fino a 100 mm
    3. Washout di FANS da almeno 2 giorni prima sia dello screening che basale.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Analysis:
    - Improvement from baseline to month 6 in WOMAC pain score of the index knee.
    -Improvement from baseline to month 6 in WOMAC physical function score of the index knee.
    Aumento del numero di pazienti veramente rispondenti OMERACT/OARSI definiti attraverso il miglioramento rispetto al baseline del dolore e della funzionalità fisica secondo il sottopunteggio 50% WOMAC con variazioni assolute di 20 mm a 6 mesi
    E.5.1.1Timepoint(s) of evaluation of this end point
    Month 6
    A 6 mesi
    E.5.2Secondary end point(s)
    - Changes from baseline to months 1, 3, 6, 12 and 24 in OARSI scores of the index knee.
    - Changes from baseline to months 1, 3, 6, 12 and 24 in VAS pain scores of the index knee.
    - Changes from baseline to months 1, 3, 6, 12 and 24 in WOMAC stiffness scores of the index knee
    - Changes from baseline to months 1, 3, 6, 12 and 24 in WOMAC global scores of the index knee
    - Changes from baseline to months 1, 3, 12 and 24 in WOMAC pain and function scores of the index knee
    - Changes from baseline to months 1, 3, 6, 12 and 24 in KOOS scores of the index knee
    - Changes from baseline to months 1, 3, 6, 12 and 24 in SAS scores of the index knee
    - Changes from baseline to months 1, 3, 6, 12 and 24 in SF-36
    - Changes from baseline to months 12 and 24 in cartilage volume/thickness of the index knee MRI (MOAKS score).
    - Changes from baseline to months 12 and 24 in femorotibial joint space of the index knee on X-ray
     Cambiamenti dal baseline ai mesi 1, 3, 6, 12 e 24 dei punteggi OARSI al ginocchio interessato.
     Cambiamenti dal baseline ai mesi 1, 3, 6, 12 e 24 dei punteggi del dolore sulla scala VAS al ginocchio interessato.
     Cambiamenti dal baseline ai mesi 1, 3, 6, 12 e 24 dei punteggi di rigidità WOMAC al ginocchio interessato
     Cambiamenti dal baseline ai mesi 1, 3, 6, 12 e 24 dei punteggi generali WOMAC al ginocchio interessato
     Cambiamenti dal baseline ai mesi 1, 3, 6, 12 e 24 dei punteggi di dolore e funzionalità WOMAC al ginocchio interessato
     Cambiamenti dal baseline ai mesi 1, 3, 6, 12 e 24 dei punteggi KOOS al ginocchio interessato.
     Cambiamenti dal baseline ai mesi 1, 3, 6, 12 e 24 dei punteggi SAS al ginocchio interessato
     Cambiamenti dal baseline ai mesi 1, 3, 6, 12 e 24 in SF-36
     Cambiamenti dal baseline ai mesi 1, 3, 6, 12 e 24 nell’uso degli analgesici.
     Cambiamenti dal baseline ai mesi 12 e 24 in punteggio MOAKS e del volume e dello spessore della cartilagine nel ginocchio interessato alla risonanza magnetica.
     Cambiamenti dal baseline ai mesi 12 e 24 nello spazio articolare femoro-tibiale ai raggi X del ginocchio interessato
    E.5.2.1Timepoint(s) of evaluation of this end point
    Months 1, 3, 6, 12 and 24
    A 1, 3, 6, 12 e 24
    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 Yes
    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 trial3
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    LVLP
    LVLP
    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 months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    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: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 153
    F.4.2.2In the whole clinical trial 153
    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)
    None
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation ECRIN European Correspondent for France
    G.4.3.4Network Country France
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-06-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-20
    P. End of Trial
    P.End of Trial StatusSuspended by CA
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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