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    The EU Clinical Trials Register currently displays   42891   clinical trials with a EudraCT protocol, of which   7066   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2020-004805-30
    Sponsor's Protocol Code Number:CLN-PXT3003-06
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-08-02
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    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)
    Studio di fase III multicentrico, randomizzato, in doppio cieco, controllato con placebo, per valutare l'efficacia, la sicurezza e la tollerabilità di PXT3003 nella malattia di Charcot-Marie-Tooth di tipo 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
    Studio di fase 3 di PXT3003 in pazienti affetti da malattia di Charcot-Marie-Tooth di tipo 1A
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberCLN-PXT3003-06
    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/ cityParigi
    B.5.3.3Post code7009
    B.5.4Telephone number0019178853598
    B.5.5Fax number0033141092231
    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 namePXT3003
    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 INNBACLOFENE
    D.3.9.1CAS number 1134-47-0
    D.3.9.2Current sponsor codena
    D.3.9.4EV Substance CodeSUB05667MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/µl microgram(s)/microlitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 16590-41-3
    D.3.9.2Current sponsor codena
    D.3.9.3Other descriptive namenaltrexone hydrochloride
    D.3.9.4EV Substance CodeSUB09143MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/µl microgram(s)/microlitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSORBITOLO
    D.3.9.1CAS number 50-70-4
    D.3.9.2Current sponsor codena
    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 Information not present in EudraCT
    D. therapy medical product Information not present in EudraCT
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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 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 di tipo 1A
    E.1.1.1Medical condition in easily understood language
    Hereditary Motor and Sensory Neuropathy
    Neuropatia motoria e sensoriale ereditaria
    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
    Valutare l'efficacia del trattamento con PXT3003 (una combinazione a dose fissa di (RS)-baclofene, naltrexone cloridrato (HCl), e D-sorbitolo) rispetto al placebo nei soggetti con malattia di Charcot-Marie-Tooth tipo 1 (CMT1A)
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of PXT3003 treatment in subjects with CMT1A
    Valutare la sicurezza e la tollerabilità del trattamento con PXT3003 in soggetti affetti da 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 antiinflammatory 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. Soggetti di sesso maschile e di sesso femminile non in gravidanza, di età compresa tra i 16 e i 65 anni con una diagnosi geneticamente provata di CMT1A.
    2. In grado di fornire il consenso/assenso informato scritto e di rispettare le procedure dello studio.
    3. Gravità da lieve a moderata valutata con un punteggio CMTNS-V2 >2 e =18.
    4. Debolezza muscolare almeno nella dorsiflessione del piede in base alla valutazione clinica.
    5. Tempo di conduzione motorio del nervo ulnare di almeno 15 m/s.
    6. Dose stabile di farmaci psicoattivi prescritti (ad esempio, antidepressivi, stimolanti, tranquillanti, antiepilettici) per almeno 4 settimane prima della randomizzazione, che non si prevede di modificare.
    7. Dose stabile di farmaci analgesici prescritti o da banco (ad esempio, paracetamolo/acetaminofene, farmaci antinfiammatori non steroidei) per almeno 2 settimane prima della randomizzazione, che non si prevede di modificare.
    8. Se di sesso femminile il soggetto deve essere: (a) sterilizzato chirurgicamente mediante isterectomia, ooforectomia bilaterale o legatura bilaterale delle tube; oppure (b) potenzialmente fertile che utilizza un metodo contraccettivo, ad esempio:
    • contraccettivo ormonale combinato (contenente estrogeni e progestinici) associato a inibizione dell'ovulazione:
    o orale
    o intravaginale
    o transdermico
    • Contraccezione ormonale basata solo su progestinici, associata a inibizione dell'ovulazione:
    o orale
    o iniettabile
    o impiantabile
    • Dispositivo intrauterino
    • Sistema intrauterino a rilascio di ormoni
    • Occlusione bilaterale delle tube
    • Partner vasectomizzato
    • Astinenza sessuale
    oppure (c) non potenzialmente fertili (cioè, in menopausa post-menopausa da almeno 1 anno)
    9. Se di sesso maschile, il soggetto deve aver subito una vasectomia o deve utilizzare un metodo affidabile di contraccezione con la partner o praticare astinenza totale dal rapporto sessuale. Il soggetto deve accettare di continuare a utilizzare il metodo di contraccezione selezionato con la partner sessuale durante lo studio e per 120 giorni dopo il completamento dello studio.
    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. Soggetti precedentemente arruolati in qualsiasi studio su PXT3003.
    2. Soggetti che vivono nella stessa abitazione e che sono stati arruolati in uno studio su PXT3003 (a causa della potenziale mancanza di un'adeguata conservazione del materiale dello studio, del rischio di mischiare i trattamenti e della potenziale apertura del cieco).
    3. CMT di qualsiasi sottotipo diverso da 1A.
    4. Punteggio ONLS di 0.
    5. Note anomalie motorie o sensoriali clinicamente significative secondarie ad una diversa causa neurologica (ad esempio, diabete, alcool, vascolare, autoimmune, neoplastica, neurodegenerativa, virus dell'immunodeficienza umana, ecc.)
    6. Soggetti che hanno subito un intervento chirurgico o che presentano un disturbo concomitante (es. artrosi grave) che riduce la mobilità della caviglia rendendo difficile, a parere dello sperimentatore, valutare l'efficacia del trattamento.
    7. Nota neuropatia periferica, miopatia o disturbo neuromuscolare di qualsiasi altro tipo.
    8. Qualsiasi altra condizione medica clinicamente significativa e/o incontrollata che, secondo l'opinione dello sperimentatore, potrebbe essere un fattore di confusione o potrebbe precludere la partecipazione o il completamento dello studio.
    9. Nota ipersensibilità o intolleranza a baclofene, naltrexone o sorbitolo.
    10. Trattamenti concomitanti che includono, ma non sono limitati a, baclofene, naltrexone, sorbitolo (forma farmaceutica), oppioidi e farmaci potenzialmente neurotossici come amiodarone, clorochina e chemioterapia in grado di indurre neuropatie periferiche. Possono essere inclusi i soggetti in grado di interrompere questi farmaci almeno 2 settimane prima della randomizzazione e per la durata dello studio.
    11. Anamnesi di porfiria.
    12. Diagnosi o anamnesi di disturbo da abuso di sostanze come definito dai criteri del Manuale diagnostico e statistico dei disturbi mentali,5a Edizione negli ultimi 12 mesi.
    13. Uso medico o ricreativo di marijuana nei 3 mesi precedenti la Visita di screening.
    14. Suicidalità attiva (per es., qualsiasi tentativo di suicidio negli ultimi 12 mesi o qualsiasi intento suicida attuale, compreso un piano, come valutato dal punteggio C-SSRS di "SÌ" alle domande 4 o 5; e/o sulla base della valutazione clinica da parte dello sperimentatore).
    15. Depressione grave attualmente attiva, come determinato da un punteggio del Questionario della Depressione di Beck–II (BDI-II) =20.
    16. Attualmente in allattamento, in gravidanza o con l'intenzione di iniziare una gravidanza durante lo studio.
    17. Alanina aminotransferasi o aspartato aminotransferasi 2 volte maggiori rispetto al limite superiore della norma.
    18. Danno renale significativo, determinato da una velocità di filtrazione glomerulare inferiore a 50 ml/min.
    19. Il soggetto ha partecipato a uno studio su un farmaco o dispositivo sperimentale entro 30 giorni prima della Visita di screening o prevede di partecipare a uno studio su un farmaco o dispositivo sperimentale durante il corso di questo studio.
    20. Il soggetto è un dipendente e/o parente dello Sponsor o dello Sperimentatore principale.
    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.
    Variazione nel punteggio ONLS modificato tra la Baseline e la Visita del Mese 15.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Month 15 visit
    Visita del Mese 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.
    Variazione dalla Baseline al Mese 15 nelle seguenti misure di esito in ordine gerarchico:
    1. 10mWT
    2. Test muscolare quantificato (QMT) (dinamometria bilaterale della dorsiflessione del piede)
    3. Impressione globale di gravità del paziente (PGI-S)
    4. Impressione globale di cambiamento del paziente (PGI-C)1
    5. CMTNS-V2
    6. QMT (impugnatura con la mano)
    1 Poiché PGI-C è già una valutazione della variazione, la variazione rispetto alla Baseline non è necessaria per questo endpoint.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Month 15 visit
    Visita del Mese 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 concerned3
    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 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
    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 - completamento della Visita al mese 15 dell'ultimo soggetto
    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.1.1.1In 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 state24
    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 Decision2021-05-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-05
    P. End of Trial
    P.End of Trial StatusOngoing
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