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    EudraCT Number:2020-004805-30
    Sponsor's Protocol Code Number:CLN-PXT3003-06
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-05-27
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2020-004805-30
    A.3Full title of the trial
    A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Assess the Efficacy, Safety, and Tolerability of PXT3003 in Charcot-Marie-Tooth type 1A (CMT1A)
    Een multicentrisch, gerandomiseerd, dubbelblind, placebogecontroleerd fase III-onderzoek ter beoordeling van de werking, veiligheid en verdraagzaamheid van PXT3003 bij Charcot Marie-Tooth type 1A (CMT1A).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 3 trial of PXT3003 in Charcot-Marie-Tooth (CMT) Type 1A patients
    Fase III-onderzoek van PXT3003 bij patienten met Charcot Marie-Tooth type 1A (CMT1A).
    A.4.1Sponsor's protocol code numberCLN-PXT3003-06
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04762758
    A.5.4Other Identifiers
    Name:IND numberNumber:122505
    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 SponsorPharnext SA
    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 supportPharnext SA
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPharnext SA
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street Address46 rue Saint Lazare
    B.5.3.2Town/ cityParis
    B.5.3.3Post code7009
    B.5.4Telephone number+19178853598
    B.5.5Fax number+33141092231
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/14/1260
    D.3 Description of the IMP
    D.3.1Product nameNA
    D.3.2Product code PXT3003
    D.3.4Pharmaceutical form Oral solution in sachet
    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 INNBACLOFEN
    D.3.9.1CAS number 1134-47-0
    D.3.9.3Other descriptive name(RS)-baclofen
    D.3.9.4EV Substance CodeSUB05667MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.6
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNALTREXONE
    D.3.9.1CAS number 16590-41-3
    D.3.9.3Other descriptive namenaltrexone hydrochloride
    D.3.9.4EV Substance CodeSUB09143MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.07
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSorbitol
    D.3.9.1CAS number 50-70-4
    D.3.9.3Other descriptive nameD-SORBITOL
    D.3.9.4EV Substance CodeSUB20837
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 placeboOral solution in sachet
    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
    Charcot Marie Tooth Type 1A
    Charcot Marie Tooth Type 1A
    E.1.1.1Medical condition in easily understood language
    Hereditary Motor and Sensory Neuropathy
    Erfelijke Motorische en Sensorische Neuropathie
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10008414
    E.1.2Term Charcot-Marie-Tooth disease
    E.1.2System Organ Class 100000004850
    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 the efficacy of treatment with PXT3003 (a fixed-dose combination of (RS)-baclofen, naltrexone hydrochloride, and D-sorbitol) compared to placebo in subjects with CMT1A
    Evalueren van de effectiviteit van de behandeling met PXT3003 (een gefixeerde-dosis combinatie van (RS)-baclofen, naltrexone hydrochloride, en D-sorbitol) vergeleken met placebo in proefpersonen met CMT1A
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of PXT3003 treatment in subjects with CMT1A
    Evalueren van de veiligheid en verdraagzaamheid van PXT3003 behandeling in proefpersonen met CMT1A
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Male and non-pregnant female subjects, aged 16 to 65 years with a genetically proven diagnosis of CMT1A
    2) Able to provide written informed consent/assent and comply with study procedures
    3) Mild-to-moderate severity assessed by CMTNS-v2 score >2 and ≤18
    4) Muscle weakness in at least foot dorsiflexion on clinical assessment
    5) Ulnar nerve motor conduction time of at least 15m/s
    6) Stable dose of prescribed psychoactive drugs (e.g. antidepressants, stimulants, tranquilizers, anti-epileptics) for at least 4 weeks prior to randomization, which is not planned to be changed
    7) Stable dose of prescribed or ‘over-the-counter’ (OTC) analgesic medications (e.g. paracetamol/acetaminophen, nonsteroidal anti-inflammatory drugs [NSAIDs]) for at least 2 weeks prior to randomization, which is not planned to be changed
    8) If female, subject must be: (a) Surgically sterilized via hysterectomy, bilateral oophorectomy, or bilateral tubal ligation; or (b) Of childbearing potential and using a birth control method such as:
    • Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
    o Oral
    o Intravaginal
    o Transdermal
    • Progestogen-only hormonal contraception associated with inhibition of ovulation:
    o Oral
    o Injectable
    o Implantable
    • Intrauterine device (IUD)
    • Intrauterine hormone-releasing system (IUS)
    • Bilateral tubal occlusion
    • Vasectomized partner
    • Sexual abstinence;
    or (c) Of non-childbearing potential (i.e., postmenopausal for at least 1 year)
    9) If male, the subject must have had a vasectomy or must use a reliable method of birth control with their partner or total abstinence from sexual intercourse. The subject must agree to continue using their selected method of birth control with their sexual partner during the study and for 120 days after study completion.

    1. Mannelijke en niet-zwangere vrouwelijke patiënten tussen 16 en 65 jaar met een genetisch bewezen diagnose van CMT1A.
    2. In staat zijn om een geïnformeerde toestemming/instemming te verstrekken en de onderzoeksprocedures te volgen.
    3. Milde tot matige ernst, beoordeeld door een CMTNS-V2-score >2 en ≤18.
    4. Spierzwakte in ten minste dorsiflexie van de voet volgens klinische beoordeling.
    5. Geleidingstijd van de motorische elleboogzenuw van ten minste 15 m/s.
    6. Stabiele dosis van voorgeschreven psychoactieve middelen (bijv. antidepressiva, stimulerende middelen, kalmeringsmiddelen, anti epileptische middelen) gedurende minstens 4 weken vóór randomisatie, zonder dat een wijziging is gepland.
    7. Stabiele dosis van voorgeschreven of vrij te verkrijgen pijnstillers (bijv. paracetamol, niet-steroïde ontstekingsremmers) gedurende minstens 2 weken vóór randomisatie, zonder dat een wijziging is gepland.
    8. Vrouwelijke patiënten moeten: (a) chirurgisch gesteriliseerd zijn via hysterectomie, bilaterale oöforectomie of bilaterale tubaligatie; of (b) in vruchtbare leeftijd zijn en een anticonceptiemethode gebruiken zoals:
    • Gecombineerde hormonale anticonceptie (met oestrogeen en progestageen) geassocieerd met ovulatieremming:
    o Oraal
    o Intravaginaal
    o Transdermaal
    • Hormonale anticonceptie met enkel progestageen, geassocieerd met ovulatieremming:
    o Oraal
    o Injecteerbaar
    o Implanteerbaar
    • Koperspiraal
    • Hormoonspiraal
    • Bilaterale tuba-occlusie
    • Partner met vasectomie
    • Seksuele onthouding
    of (c) Niet in vruchtbare leeftijd (d.w.z. postmenopauzaal gedurende minstens 1 jaar)
    9. Mannelijke patiënten moeten een vasectomie hebben ondergaan of een betrouwbare anticonceptiemethode gebruiken met hun partner, of zich geheel onthouden van seksuele betrekkingen. De proefpersonen moeten ermee instemmen om gedurende het onderzoek en tot 120 dagen na afloop van het onderzoek hun gekozen methode voor geboortebeperking met hun seksuele partner te gebruiken.
    E.4Principal exclusion criteria
    1) Subjects previously enrolled in any PXT3003 study
    2) Subjects living in the same household and enrolled in a PXT3003 study (due to potential lack of adequate storage for study material, risk of mixing treatments and potential unblinding)
    3) CMT of any subtype other than 1A
    4) ONLS score of 0
    5) Known clinically significant motor or sensory abnormalities secondary to a different neurological cause (e.g. diabetes, alcohol, vascular, autoimmune, neoplastic, neurodegenerative, HIV, etc.)
    6) Subjects who have had any surgery or have a concomitant disorder (e.g. severe arthrosis) that reduces the mobility of the ankle making it, in the opinion of the investigator, difficult to assess the efficacy of the treatment.
    7) Known peripheral neuropathy, myopathy, or neuromuscular disorder of any other kind
    8) Any other clinically significant and/or uncontrolled medical condition that, in the opinion of the investigator, could be a confound or may preclude successful participation or completion of the study
    9) Known hypersensitivity or intolerance to baclofen, naltrexone, or sorbitol
    10) Concomitant treatments including but not limited to baclofen, naltrexone, sorbitol (pharmaceutical form), opioids, and potentially neurotoxic drugs such as amiodarone, chloroquine, and chemotherapeutics capable of inducing peripheral neuropathy. Subjects able to stop these medications at least 2 weeks before randomization and for the study duration may be included
    11) History of porphyria
    12) Diagnosis or history of substance use disorder by DSM-V criteria within the past 12 months
    13) Medical or recreational use of marijuana in the 3 months prior to the Screening Visit
    14) Active suicidality (e.g. any suicide attempts within the past 12 months or any current suicide intent, including a plan, as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) score of “YES” on questions 4 or 5; and/or based on clinical evaluation by the investigator)
    15) Currently active major depression, as determined by a Beck Depression Inventory (BDI-II) score ≥ 20
    16) Currently lactating, pregnant, or planning on becoming pregnant during the study
    17) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 2 times the upper limit of normal (ULN)
    18) Significant renal impairment as determined by Glomerular Filtration Rate (GFR) of less than 50 mL/min
    19) Subject has participated in an investigational drug or device study within 30 days prior to the Screening Visit or plans to participate in an investigational drug or device study during the course of this study
    20) Subject is a dependent and/or relative of the Sponsor or investigator.
    1. Patiënten die eerder zijn ingeschreven voor een PXT3003 onderzoek.
    2. Patiënten die in hetzelfde huishouden wonen en zich hebben ingeschreven voor een PXT3003-onderzoek (wegens een mogelijk gebrek aan geschikte opslag voor onderzoeksmateriaal, het risico op het mengen van behandelingen en mogelijk opheffen van blindering).
    3. CMT van een ander subtype dan 1A.
    4. ONLS-score van 0.
    5. Bekende klinisch significante motorische of zintuiglijke afwijkingen die voortkomen uit een andere neurologische oorzaak (bijv. diabetes, alcohol, vasculair, auto-immuun, neoplastisch, neurodegeneratief, humaan immunodeficiëntievirus enz.).
    6. Patiënten die chirurgie hebben ondergaan, of een bijkomende aandoening (bijv. ernstige artrose) hebben die de mobiliteit van de enkel beperkt, waardoor het naar de mening van de onderzoeker moeilijk is om de werkzaamheid van de behandeling te beoordelen.
    7. Bekende perifere neuropathie, myopathie of neuromusculaire aandoening van een andere soort.
    8. Een andere klinisch significante en/of ongecontroleerde medische aandoening die, naar de mening van de onderzoeker, tot verwarring kan leiden of een succesvolle deelname aan of voltooiing van het onderzoek kan verhinderen.
    9. Bekende overgevoeligheid of intolerantie voor baclofen, naltrexon of sorbitol.
    10. Gelijktijdige behandelingen, waaronder maar niet beperkt tot baclofen, naltrexon, sorbitol (farmaceutische vorm), opioïden en potentieel neurotoxische geneesmiddelen zoals amiodaron, chloroquine en chemotherapeutica die perifere neuropathie kunnen induceren. Patiënten die deze geneesmiddelen minstens 2 weken voor randomisatie en gedurende het onderzoek kunnen stopzetten, kunnen opgenomen worden.
    11. Voorgeschiedenis van porfyrie.
    12. Diagnose of voorgeschiedenis van drugsgebruik volgens de criteria van Diagnostisch en statistisch handboek voor psychische stoornissen-5e editie in de afgelopen 12 maanden.
    13. Medisch of recreatief gebruik van marihuana in de 3 maanden voor het screeningbezoek.
    14. Actieve suïcidaliteit (bijv. zelfmoordpogingen binnen de voorbije 12 maanden of huidige zelfmoordneigingen, zoals beoordeeld door de C SSRS-score van 'JA' op vraag 4 of 5; en/of op basis van klinische evaluatie door de onderzoeker).
    15. Momenteel actieve ernstige depressie, zoals bepaald door een Beck Depression Inventory-II (BDI-II)-score ≥20.
    16. Patiënt die borstvoeding geeft, zwanger is of van plan is om zwanger te worden tijdens het onderzoek.
    17. Niveaus van alanine-aminotransferase (ALAT) of aspartaat aminotransferase (ASAT) hoger dan 2 maal de bovengrens van normaal.
    18. Significante nierfunctiestoornis, zoals bepaald door glomerulus filtratiesnelheid minder dan 50 ml/min.
    19. Patiënt heeft deelgenomen aan een onderzoek naar een onderzoeksgeneesmiddel of hulpmiddel binnen 30 dagen voor het screeningbezoek of plant om deel te nemen aan een dergelijk onderzoek in de loop van dit onderzoek.
    20. Patiënt is afhankelijk en/of een familielid van de opdrachtgever of hoofdonderzoeker.
    E.5 End points
    E.5.1Primary end point(s)
    The change in the modified Overall Neuropathy Limitation Scale (ONLS) between baseline and the Month 15 visit.
    De verandering in de gewijzigde "Overall Neuropathy Limitation Scale" (ONLS) tussen basislijn en het bezoek in maand 15.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Month 15 visit
    Visite maand 15
    E.5.2Secondary end point(s)
    The change from baseline to month 15 in the following outcome measures in hierarchical order:
    1) 10-Meter Walk Test (10mWT)
    2) Quantified Muscular Testing (bilateral foot dorsiflexion dynamometry)
    3) Patient Global Impression of Severity (PGI-S)
    4) Patient Global Impression of Change (PGI-C)*
    5) Charcot-Marie-Tooth Neuropathy Score, version 2 (CMTNS-v2)
    6) Quantified Muscular Testing (hand grip)
    * Because the PGI-C is already a change assessment, the change from Baseline is not needed for this endpoint.
    De verandering van basislijn tot maand 15 in de volgende resultaten in hiërarchische volgorde:
    1. 10mWT
    2. Kwantitatieve spiertests (QMT) (bilaterale dynamometrie van voet-dorsiflexie)
    3. Patient Global Impression of Severity (PGI-S)
    4. Patient Global Impression of Change (PGI-C)*
    5. CMTNS-V2
    6. QMT (handgreep)
    * Omdat de PGI-C al een beoordeling van de verandering is, is de verandering vanaf de basislijn niet nodig voor dit eindpunt.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Month 15 visit
    Visite maand 15
    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 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. 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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 - completion of the Month 15 Visit by the last subject
    LVLS: Afronding van de maand 15 visite door de laatste proefpersoon.
    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 months4
    E.8.9.1In the Member State concerned days28
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days28
    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: 56
    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) Yes
    F. of subjects for this age range: 56
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 271
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 23
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 130
    F.4.2.2In the whole clinical trial 350
    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)
    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 Decision2021-05-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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